iba molecular north america, inc., license amendment ... · texas bop permit enclosed. jeff...

72
&r, () March 14,2012 Commercial and R&D Branch Division of Nuclear Materials Safety U.S. Nuclear Regulatory Commission, Region I 475 Allendale Road King of Prussia, PA 19406-1415 RE: Amendment Request to Add and Remove Authorized Nuclear Pharmacists IBA Molecular North America, Inc. - NRC License Nos. 45-25221-01 MD ).- , . To Whom It May Concern: Please amend the above referenced license to add the following persons as authorized nuclear pharmacists: Adrryl Addison Triad Georgia listed Af\lP. Copy enclosed. New York BOP permit enclosed. GaryAlmase IBA Virginia listed ANP. Copy enclosed. Virginia BOP permit enclosed. Shahnam Biglari IBA California listed ANP. Copy enclosed. California BOP permit enclosed. Alex Freed IBA Somerset New Jersey listed ANP. Copy enclosed. New Jersey BOP permit enclosed. Patrick Sillo IBA Somerset New Jersey listed ANP. Copy enclosed. New Jersey BOP permit enclosed. Arti Jinsi-Parimoo IBA Totowa New Jersey listed ANP. Copy enclosed. New Jersey BOP permit enclosed. Beth Kraemer IBA Totowa New Jersey listed ANP. Copy enclosed. New Jersey BOP permit enclosed. Darian Kirby IBA Texas listed ANP. Copy enclosed. Texas BOP permit enclosed. Julius Martin IBA Texas listed ANP. Copy enclosed. Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal Patel IBA Ohio listed ANP. Copy enclosed. Ohio BOP permit enclosed. Please delete from License Condition 11 B Jay Pfeiffer, Brad Richardson and Michael C. Tingler. ) 77/-/'}-- .... NMSSIRGN1 MATERtALS-002

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Page 1: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

ampr ()

March 142012

Commercial and RampD Branch Division of Nuclear Materials Safety US Nuclear Regulatory Commission Region I 475 Allendale Road King of Prussia PA 19406-1415

RE Amendment Request to Add and Remove Authorized Nuclear Pharmacists IBA Molecular North America Inc - NRC License Nos 45-25221-01 MD

) shy

To Whom It May Concern

Please amend the above referenced license to add the following persons as authorized nuclear pharmacists

Adrryl Addison Triad Georgia listed AflP Copy enclosed New York BOP permit enclosed

GaryAlmase IBA Virginia listed ANP Copy enclosed Virginia BOP permit enclosed

Shahnam Biglari IBA California listed ANP Copy enclosed California BOP permit enclosed

Alex Freed IBA Somerset New Jersey listed ANP Copy enclosed New Jersey BOP permit enclosed

Patrick Sillo IBA Somerset New Jersey listed ANP Copy enclosed New Jersey BOP permit enclosed

Arti Jinsi-Parimoo IBA Totowa New Jersey listed ANP Copy enclosed New Jersey BOP permit enclosed

Beth Kraemer IBA Totowa New Jersey listed ANP Copy enclosed New Jersey BOP permit enclosed

Darian Kirby IBA Texas listed ANP Copy enclosed Texas BOP permit enclosed

Julius Martin IBA Texas listed ANP Copy enclosed Texas BOP permit enclosed

Jeff Kuehnhoff PETNet Texas listed ANP Copy enclosed Massachusetts BOP permit enclosed

Kunal Patel IBA Ohio listed ANP Copy enclosed Ohio BOP permit enclosed

Please delete from License Condition 11 B Jay Pfeiffer Brad Richardson and Michael C Tingler

) 77--- ~ NMSSIRGN1 MATERtALS-002

We appreciate your assistance with this transaction If you have any questions about this request please contact Jim Kostka at (202) 207-5437

Sincerely

David W Peliicciarini CHP Vice President RAlQAlEHS ISA Molecular North America Inc

cc Gregory Hisel Director Health Physics Ron Lough Site Manager Morgantown Michael Roberts Site RSO Kansas City

Page 12

Attachments

Adrryl Addison Triad Georgia RAM License New York BOP permit

Georgia Department of Natural Resources 4220 International Parkway Suite 100 Atlanta Georgia 30354

Noel tlolcomb CommisSioner Envlronmentlll (o~clkm Division

Catol A Couch pnDbull Ohectot (404) 3Glmiddot2676

RADIOACTive MATERIALS PROGRAM GEORGIA RADIOACTIVE MATERIALS LICENSE

Pursuenl to Iho Geor9ia Rlldialion Conlrol Act OCGA 31middot13 (HB 947) 1990 and tho Georgia Department of Naturlll Resources Rulegt IIlld Rcgulallons deslgnllted Chapler 391-3-171 end In tellanco on stalemant end roprosonlaUons herelofor~ mlldo by tho lioeneaa designated below iii license is hereby lsaued luthllri2lng luch licen810 10 transfer receive P01l611116 and ule the radlotKllve malarlal(s) designated below anD 10 use suell ntdloBclve ma1erlals for tile purpOS1J(II) and et Ihft pla~($) designated below Thill license 19 subject 10 al applicable rults lind regulallons of 1he Georgia Department or Natural ResouIC6t1 and olders luuod by 1I1i Department now orhereaIter in etrecl anCllo any condition 8pCifled below

Page 1of 6 Pages License Number GA 1582-1

License (1 Name and 2 Address) 3 In accordance wllh application dated May 6 2008 License Number GA

triad Isotopes Inc 1~82middot1 Is Issued to read aa follows dba Nuclear Pharmacy of Georgia 200 South Orange Avenue Suite 2100 4 Expiration Date June 30 2013 Orlando Florida 32B01

5 Telephone Numbr 407455middot6700 Norcross Number 6781242-1870

6 RADIOACTiVe MATERIAL 7 CHEMICAL ANDOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANYONE

TIME

A Any radloaotlve material wlth A Any A Not to exceed SOD atomiG numbers 1 throllgh 83 millicurie~ per except molybdenum 99 radionuclide and 2 Curie technetium 99m iodine 131 total xenon 133 and thallium 201

B Any radloaotlve material 8 Any 8 35 CurIes authorized in (41) of Rule 3913shy17-05 except iodine 131 and technetium 99m

C Any radioactive material C Any C 35 Curies authorized In (48) of Rule 391middot3shy7-05

D Iodine 131 D Any form except $ealed D 2 Curiee source

C Molybdenum 99 e Any E 35 Curies

F Technetium gem F Anyforrn except sealed F 25 Curies source

Georgia Department of Natnral Resources Radioactive Materials License

Supplementary Sheet

Page 2 of 6 Pages license Number GA 1562middot1

6 RADIOACTIVE MATERIAL T CHEMICAl ANDIOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANY ONE

TIME

G Xenon 133 G UnIt dose containers G 1 Curle

H Yttrium SO H Liquid H 110 millicuries no standard to exceed 52 mllliollries

I Iodine 125 I Meta-iodobenzl guanidine I 100 millicuries

J IOdlne-131 Bexxar J 1-131 Tosllumomab J 500 mllllcurtes

K Samariummiddot153 K Samarium Lexidronam K 500 millicuries

L Strontium 89 L Strontium Chloride L 500 mlllicuries

M Any radloacllve malerial M Prepackaged In vitro M 100 mllllourlee Identified in (6)(g)1 of Rule 391- diagnostic test kits 3middot17middot02

N Any radioactive material N Any N 30 mllUcuries 15 mCi for authOrized by (32) of Rule 391middot halfmiddotllfe pound 120 days and 3-17-05 200CI for half~lire gt

120days

0 Iodine 125 O Sealed Source O 500 mllilourles

P Palladium 103 P Sealed Source P 500 millicurie

Q Depleted Uranium O Malal encased in stainless Q 101 kilograms steel

9 AUTHORizeD USE

A Redistribution of prepared radlopharmaceuticals to authorized recipients

B Preparing dispensing andor dIstribution of radlopharmaceutlcals to autholiled reCipients Use of technetIum 99m Pertechnetate for processing with reagent kits in preparing radlopharmacaullcals

C L Preparing dispensing andor distribution of radlopharmaceutioals to authoriced recipients

M Redistribution of prepackaged In vitro kits to general and specific licenses

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 3 of 6 Pages License Number GA 1582-1

N InslrumenteHon Calibration

o-P Sealed sources for brachytherapy or diagnosis to be redistributed will be obtained from a manufacturer authorzed 10 distribute sealed sources for brachytherapy or diagnosis according to a speCific license issued pursuant to 02(11)mmiddot

Q Shielding for molybdenum 991echnetium 99m generators

CONDITIONS

10 Radioactive materia shall be used only althe licensees facilities at 3100 Medlock Bridge Road Bulding 300 Suite 360 Norcross Georgia 30072

11 The licensee shall comply with the provisions of Georgia Department of Natural Resources Rule 391-3-17-03 Standards for Protection Against Radiation Amended Rule 391middot3-17-05 Use of Radlonuclides in the Healing Arts Amended Rule 391-3-17-06 Transportation of Radioactive Material Amended and Rule 391-3-17-07 Notice Instructions end Reports to Workers Inspections Amended

12 In accordance with DNR Board Policy adopted May 28 2003 the fees associated with this license fee category A8a are

Application fee $340000 Annual fee $458000 Amendment fee $46000 Non-routine Inspection fee $190000

Checks for the fees should be made payable to the Department of Natural Resources Radioaotive Materials Program and mailed to the following address

Radioactive Materials Fees PO Box 101161

Atlanta GA 30392

Mail license applications and amendment requests to the following address

Radioactive Materials Program 4220 Internatronal ParkWay Suite 100

Atlanta GA ~0354

All license applications amendmentB and fee payments should be mailed the same day

Annual fees are billed by the Department at the beginning of each fiscal year

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 4 of 6 Pages License Number GA 1562middot1

Conditions (continued)

13 The Radiation Safety Officer in this program 9hall be Walter Holsl PharmD BeNP

14 A Licensed malarial shall be used by or under the supervision of

1) A pharmacist working or designated as an authorized nuclear pharmaclet in accordance with Rule 391-3-17-02(11)(i) or (Iv) or

2) Authorized nuclear pharmacist(s) Dave Abbott R Ph BCNP Adryl Addison Pharm D Chris Connell Pharm O Walter Holst Pharm 0 BeN John Michael Walker Pharm D Mark MUllinax Pharm D and Denny Sims Pharm O

B At least one Individual meeting the reqvlrements of this condition shall be physioally present at the authorized place of use whenever radioactive malerlalls being used

15 The licenseE shall perform required tests for leakage or contamination at intervals not to exceed six (6) months In accordance with Rule 391-3-17-03(6) Analysis of the tests shall be performed by persons specifically authorized by the Department the US Nuclear Regulatory Commission or an Agreement State to pelform such services

16 Sealed sources containing radioactive materi21 shall not beopened by Ihe licensee

17 The licensee shall conduct a physical Inventory every six months of sealed sources In accordance with Rule 391-S-17-05(33)(d

1S Any proposed changes In packagIng shielding or labeling shall be submitted for review to the Radioactive Materials Program Georgia Department of Natural Resources 4220 IntemaUonaJ Parkway Suite 100 Atlanta Georgia 30334 or present mailing address

19 The licensee is aulhorized to hold radioactive material with a physioal half-life of less than 120 days for decaymiddotinmiddotstorage before dispoBalln ordinary trash in accordance with Rule 391-3-17shy05(40

20 The licensee shall possess and use instrumentation to measure the radioaellvlly of radiopharmaceutlcals in accordance with Rvle 391middot3middot17-0211)(i)6

21 The licensee is authorized to retrieve receive and dispose of radioactive waste from Its customers limited to raciopharmacy supplied syringes and vials and Iheir components

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 5 of 6 Pages License Number GA 1582middot1

Conditions (continued)

22 A Radlon uclldes separated from a generator either by elution of a generator or by an extraction process shall be tesled to detect and quantify contaminant activity In accordance with Rule 391-3-17-05(45)(b

B Prior to first use of a generator the licensee shall establish written procedures for personnel performing lests to detect and quantify contaminants These procedures shall inolude all necessary calculations and steps to be taken If aotlvlUes of contaminants in excess of the limits specified In 391-3-17-05(45)(a) are detected

C Personnel performing tests to deleet and quantify contaminants shall be gIVen specific training in performing these tests prior 10 conductIng such tests

D 1 The licensee shall maintain for inspecUon by the Department records of the results of each test performed 10 detect and quantify contaminants and records of training given to personnel performing these tests

2 Records described In Subltem 01 above shall be maintained for three (3) years following the performance of the lasts and the training of personnel

23 The licensee shall not transfer possession andor control of materials or producls containing radioactive material as a contaminant except

A By transfer of waste 10 an authorized recipient

B By transfer to a specifically licensed recipient or

C As provided otherwise by a specific condition of this license pursuant to the requiremenls of (13) of Rule 391-3-17-03

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page (1 of 6 Pages LIcense Number GA 1582-1

ConditlOIlS (contInued)

24 In addition to the possession limits in Item 8 1he licensee shall further restrict the possession of licensed material with a half-life greater than 120 days to quantities lees than those specified In Rule 391middot3middot17028)(g)4 Exceeding quantities in 02(8(g4 requires 1he submittal of Ii financial assurance mechanism or a decommissioning funding plan

25 In addition to the p09sesslon limits in Item 8 the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in Rule 391-3shy1702(21)(e) Schedule E which requires consideration of the need for an emergency plan (02(7)(hraquo) for responding to a release of licensed material

26 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with statements representations and procedures contained in the documents Including any enclosures listed below

A Application with enclosures dated May 62008 and signed by William P McCormick Senior VP amp General Couneel

The Georgia Department of Natural Resources regulations shall govern Ltnless the statements representations and procedures in the licensees application and oorrespondence are mere restrictive than the Regulations

FOR THE OEPARTMENT OF NATURAL RESOURCES

Date June 13 2008 BY

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 2: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

We appreciate your assistance with this transaction If you have any questions about this request please contact Jim Kostka at (202) 207-5437

Sincerely

David W Peliicciarini CHP Vice President RAlQAlEHS ISA Molecular North America Inc

cc Gregory Hisel Director Health Physics Ron Lough Site Manager Morgantown Michael Roberts Site RSO Kansas City

Page 12

Attachments

Adrryl Addison Triad Georgia RAM License New York BOP permit

Georgia Department of Natural Resources 4220 International Parkway Suite 100 Atlanta Georgia 30354

Noel tlolcomb CommisSioner Envlronmentlll (o~clkm Division

Catol A Couch pnDbull Ohectot (404) 3Glmiddot2676

RADIOACTive MATERIALS PROGRAM GEORGIA RADIOACTIVE MATERIALS LICENSE

Pursuenl to Iho Geor9ia Rlldialion Conlrol Act OCGA 31middot13 (HB 947) 1990 and tho Georgia Department of Naturlll Resources Rulegt IIlld Rcgulallons deslgnllted Chapler 391-3-171 end In tellanco on stalemant end roprosonlaUons herelofor~ mlldo by tho lioeneaa designated below iii license is hereby lsaued luthllri2lng luch licen810 10 transfer receive P01l611116 and ule the radlotKllve malarlal(s) designated below anD 10 use suell ntdloBclve ma1erlals for tile purpOS1J(II) and et Ihft pla~($) designated below Thill license 19 subject 10 al applicable rults lind regulallons of 1he Georgia Department or Natural ResouIC6t1 and olders luuod by 1I1i Department now orhereaIter in etrecl anCllo any condition 8pCifled below

Page 1of 6 Pages License Number GA 1582-1

License (1 Name and 2 Address) 3 In accordance wllh application dated May 6 2008 License Number GA

triad Isotopes Inc 1~82middot1 Is Issued to read aa follows dba Nuclear Pharmacy of Georgia 200 South Orange Avenue Suite 2100 4 Expiration Date June 30 2013 Orlando Florida 32B01

5 Telephone Numbr 407455middot6700 Norcross Number 6781242-1870

6 RADIOACTiVe MATERIAL 7 CHEMICAL ANDOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANYONE

TIME

A Any radloaotlve material wlth A Any A Not to exceed SOD atomiG numbers 1 throllgh 83 millicurie~ per except molybdenum 99 radionuclide and 2 Curie technetium 99m iodine 131 total xenon 133 and thallium 201

B Any radloaotlve material 8 Any 8 35 CurIes authorized in (41) of Rule 3913shy17-05 except iodine 131 and technetium 99m

C Any radioactive material C Any C 35 Curies authorized In (48) of Rule 391middot3shy7-05

D Iodine 131 D Any form except $ealed D 2 Curiee source

C Molybdenum 99 e Any E 35 Curies

F Technetium gem F Anyforrn except sealed F 25 Curies source

Georgia Department of Natnral Resources Radioactive Materials License

Supplementary Sheet

Page 2 of 6 Pages license Number GA 1562middot1

6 RADIOACTIVE MATERIAL T CHEMICAl ANDIOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANY ONE

TIME

G Xenon 133 G UnIt dose containers G 1 Curle

H Yttrium SO H Liquid H 110 millicuries no standard to exceed 52 mllliollries

I Iodine 125 I Meta-iodobenzl guanidine I 100 millicuries

J IOdlne-131 Bexxar J 1-131 Tosllumomab J 500 mllllcurtes

K Samariummiddot153 K Samarium Lexidronam K 500 millicuries

L Strontium 89 L Strontium Chloride L 500 mlllicuries

M Any radloacllve malerial M Prepackaged In vitro M 100 mllllourlee Identified in (6)(g)1 of Rule 391- diagnostic test kits 3middot17middot02

N Any radioactive material N Any N 30 mllUcuries 15 mCi for authOrized by (32) of Rule 391middot halfmiddotllfe pound 120 days and 3-17-05 200CI for half~lire gt

120days

0 Iodine 125 O Sealed Source O 500 mllilourles

P Palladium 103 P Sealed Source P 500 millicurie

Q Depleted Uranium O Malal encased in stainless Q 101 kilograms steel

9 AUTHORizeD USE

A Redistribution of prepared radlopharmaceuticals to authorized recipients

B Preparing dispensing andor dIstribution of radlopharmaceutlcals to autholiled reCipients Use of technetIum 99m Pertechnetate for processing with reagent kits in preparing radlopharmacaullcals

C L Preparing dispensing andor distribution of radlopharmaceutioals to authoriced recipients

M Redistribution of prepackaged In vitro kits to general and specific licenses

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 3 of 6 Pages License Number GA 1582-1

N InslrumenteHon Calibration

o-P Sealed sources for brachytherapy or diagnosis to be redistributed will be obtained from a manufacturer authorzed 10 distribute sealed sources for brachytherapy or diagnosis according to a speCific license issued pursuant to 02(11)mmiddot

Q Shielding for molybdenum 991echnetium 99m generators

CONDITIONS

10 Radioactive materia shall be used only althe licensees facilities at 3100 Medlock Bridge Road Bulding 300 Suite 360 Norcross Georgia 30072

11 The licensee shall comply with the provisions of Georgia Department of Natural Resources Rule 391-3-17-03 Standards for Protection Against Radiation Amended Rule 391middot3-17-05 Use of Radlonuclides in the Healing Arts Amended Rule 391-3-17-06 Transportation of Radioactive Material Amended and Rule 391-3-17-07 Notice Instructions end Reports to Workers Inspections Amended

12 In accordance with DNR Board Policy adopted May 28 2003 the fees associated with this license fee category A8a are

Application fee $340000 Annual fee $458000 Amendment fee $46000 Non-routine Inspection fee $190000

Checks for the fees should be made payable to the Department of Natural Resources Radioaotive Materials Program and mailed to the following address

Radioactive Materials Fees PO Box 101161

Atlanta GA 30392

Mail license applications and amendment requests to the following address

Radioactive Materials Program 4220 Internatronal ParkWay Suite 100

Atlanta GA ~0354

All license applications amendmentB and fee payments should be mailed the same day

Annual fees are billed by the Department at the beginning of each fiscal year

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 4 of 6 Pages License Number GA 1562middot1

Conditions (continued)

13 The Radiation Safety Officer in this program 9hall be Walter Holsl PharmD BeNP

14 A Licensed malarial shall be used by or under the supervision of

1) A pharmacist working or designated as an authorized nuclear pharmaclet in accordance with Rule 391-3-17-02(11)(i) or (Iv) or

2) Authorized nuclear pharmacist(s) Dave Abbott R Ph BCNP Adryl Addison Pharm D Chris Connell Pharm O Walter Holst Pharm 0 BeN John Michael Walker Pharm D Mark MUllinax Pharm D and Denny Sims Pharm O

B At least one Individual meeting the reqvlrements of this condition shall be physioally present at the authorized place of use whenever radioactive malerlalls being used

15 The licenseE shall perform required tests for leakage or contamination at intervals not to exceed six (6) months In accordance with Rule 391-3-17-03(6) Analysis of the tests shall be performed by persons specifically authorized by the Department the US Nuclear Regulatory Commission or an Agreement State to pelform such services

16 Sealed sources containing radioactive materi21 shall not beopened by Ihe licensee

17 The licensee shall conduct a physical Inventory every six months of sealed sources In accordance with Rule 391-S-17-05(33)(d

1S Any proposed changes In packagIng shielding or labeling shall be submitted for review to the Radioactive Materials Program Georgia Department of Natural Resources 4220 IntemaUonaJ Parkway Suite 100 Atlanta Georgia 30334 or present mailing address

19 The licensee is aulhorized to hold radioactive material with a physioal half-life of less than 120 days for decaymiddotinmiddotstorage before dispoBalln ordinary trash in accordance with Rule 391-3-17shy05(40

20 The licensee shall possess and use instrumentation to measure the radioaellvlly of radiopharmaceutlcals in accordance with Rvle 391middot3middot17-0211)(i)6

21 The licensee is authorized to retrieve receive and dispose of radioactive waste from Its customers limited to raciopharmacy supplied syringes and vials and Iheir components

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 5 of 6 Pages License Number GA 1582middot1

Conditions (continued)

22 A Radlon uclldes separated from a generator either by elution of a generator or by an extraction process shall be tesled to detect and quantify contaminant activity In accordance with Rule 391-3-17-05(45)(b

B Prior to first use of a generator the licensee shall establish written procedures for personnel performing lests to detect and quantify contaminants These procedures shall inolude all necessary calculations and steps to be taken If aotlvlUes of contaminants in excess of the limits specified In 391-3-17-05(45)(a) are detected

C Personnel performing tests to deleet and quantify contaminants shall be gIVen specific training in performing these tests prior 10 conductIng such tests

D 1 The licensee shall maintain for inspecUon by the Department records of the results of each test performed 10 detect and quantify contaminants and records of training given to personnel performing these tests

2 Records described In Subltem 01 above shall be maintained for three (3) years following the performance of the lasts and the training of personnel

23 The licensee shall not transfer possession andor control of materials or producls containing radioactive material as a contaminant except

A By transfer of waste 10 an authorized recipient

B By transfer to a specifically licensed recipient or

C As provided otherwise by a specific condition of this license pursuant to the requiremenls of (13) of Rule 391-3-17-03

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page (1 of 6 Pages LIcense Number GA 1582-1

ConditlOIlS (contInued)

24 In addition to the possession limits in Item 8 1he licensee shall further restrict the possession of licensed material with a half-life greater than 120 days to quantities lees than those specified In Rule 391middot3middot17028)(g)4 Exceeding quantities in 02(8(g4 requires 1he submittal of Ii financial assurance mechanism or a decommissioning funding plan

25 In addition to the p09sesslon limits in Item 8 the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in Rule 391-3shy1702(21)(e) Schedule E which requires consideration of the need for an emergency plan (02(7)(hraquo) for responding to a release of licensed material

26 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with statements representations and procedures contained in the documents Including any enclosures listed below

A Application with enclosures dated May 62008 and signed by William P McCormick Senior VP amp General Couneel

The Georgia Department of Natural Resources regulations shall govern Ltnless the statements representations and procedures in the licensees application and oorrespondence are mere restrictive than the Regulations

FOR THE OEPARTMENT OF NATURAL RESOURCES

Date June 13 2008 BY

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 3: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Attachments

Adrryl Addison Triad Georgia RAM License New York BOP permit

Georgia Department of Natural Resources 4220 International Parkway Suite 100 Atlanta Georgia 30354

Noel tlolcomb CommisSioner Envlronmentlll (o~clkm Division

Catol A Couch pnDbull Ohectot (404) 3Glmiddot2676

RADIOACTive MATERIALS PROGRAM GEORGIA RADIOACTIVE MATERIALS LICENSE

Pursuenl to Iho Geor9ia Rlldialion Conlrol Act OCGA 31middot13 (HB 947) 1990 and tho Georgia Department of Naturlll Resources Rulegt IIlld Rcgulallons deslgnllted Chapler 391-3-171 end In tellanco on stalemant end roprosonlaUons herelofor~ mlldo by tho lioeneaa designated below iii license is hereby lsaued luthllri2lng luch licen810 10 transfer receive P01l611116 and ule the radlotKllve malarlal(s) designated below anD 10 use suell ntdloBclve ma1erlals for tile purpOS1J(II) and et Ihft pla~($) designated below Thill license 19 subject 10 al applicable rults lind regulallons of 1he Georgia Department or Natural ResouIC6t1 and olders luuod by 1I1i Department now orhereaIter in etrecl anCllo any condition 8pCifled below

Page 1of 6 Pages License Number GA 1582-1

License (1 Name and 2 Address) 3 In accordance wllh application dated May 6 2008 License Number GA

triad Isotopes Inc 1~82middot1 Is Issued to read aa follows dba Nuclear Pharmacy of Georgia 200 South Orange Avenue Suite 2100 4 Expiration Date June 30 2013 Orlando Florida 32B01

5 Telephone Numbr 407455middot6700 Norcross Number 6781242-1870

6 RADIOACTiVe MATERIAL 7 CHEMICAL ANDOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANYONE

TIME

A Any radloaotlve material wlth A Any A Not to exceed SOD atomiG numbers 1 throllgh 83 millicurie~ per except molybdenum 99 radionuclide and 2 Curie technetium 99m iodine 131 total xenon 133 and thallium 201

B Any radloaotlve material 8 Any 8 35 CurIes authorized in (41) of Rule 3913shy17-05 except iodine 131 and technetium 99m

C Any radioactive material C Any C 35 Curies authorized In (48) of Rule 391middot3shy7-05

D Iodine 131 D Any form except $ealed D 2 Curiee source

C Molybdenum 99 e Any E 35 Curies

F Technetium gem F Anyforrn except sealed F 25 Curies source

Georgia Department of Natnral Resources Radioactive Materials License

Supplementary Sheet

Page 2 of 6 Pages license Number GA 1562middot1

6 RADIOACTIVE MATERIAL T CHEMICAl ANDIOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANY ONE

TIME

G Xenon 133 G UnIt dose containers G 1 Curle

H Yttrium SO H Liquid H 110 millicuries no standard to exceed 52 mllliollries

I Iodine 125 I Meta-iodobenzl guanidine I 100 millicuries

J IOdlne-131 Bexxar J 1-131 Tosllumomab J 500 mllllcurtes

K Samariummiddot153 K Samarium Lexidronam K 500 millicuries

L Strontium 89 L Strontium Chloride L 500 mlllicuries

M Any radloacllve malerial M Prepackaged In vitro M 100 mllllourlee Identified in (6)(g)1 of Rule 391- diagnostic test kits 3middot17middot02

N Any radioactive material N Any N 30 mllUcuries 15 mCi for authOrized by (32) of Rule 391middot halfmiddotllfe pound 120 days and 3-17-05 200CI for half~lire gt

120days

0 Iodine 125 O Sealed Source O 500 mllilourles

P Palladium 103 P Sealed Source P 500 millicurie

Q Depleted Uranium O Malal encased in stainless Q 101 kilograms steel

9 AUTHORizeD USE

A Redistribution of prepared radlopharmaceuticals to authorized recipients

B Preparing dispensing andor dIstribution of radlopharmaceutlcals to autholiled reCipients Use of technetIum 99m Pertechnetate for processing with reagent kits in preparing radlopharmacaullcals

C L Preparing dispensing andor distribution of radlopharmaceutioals to authoriced recipients

M Redistribution of prepackaged In vitro kits to general and specific licenses

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 3 of 6 Pages License Number GA 1582-1

N InslrumenteHon Calibration

o-P Sealed sources for brachytherapy or diagnosis to be redistributed will be obtained from a manufacturer authorzed 10 distribute sealed sources for brachytherapy or diagnosis according to a speCific license issued pursuant to 02(11)mmiddot

Q Shielding for molybdenum 991echnetium 99m generators

CONDITIONS

10 Radioactive materia shall be used only althe licensees facilities at 3100 Medlock Bridge Road Bulding 300 Suite 360 Norcross Georgia 30072

11 The licensee shall comply with the provisions of Georgia Department of Natural Resources Rule 391-3-17-03 Standards for Protection Against Radiation Amended Rule 391middot3-17-05 Use of Radlonuclides in the Healing Arts Amended Rule 391-3-17-06 Transportation of Radioactive Material Amended and Rule 391-3-17-07 Notice Instructions end Reports to Workers Inspections Amended

12 In accordance with DNR Board Policy adopted May 28 2003 the fees associated with this license fee category A8a are

Application fee $340000 Annual fee $458000 Amendment fee $46000 Non-routine Inspection fee $190000

Checks for the fees should be made payable to the Department of Natural Resources Radioaotive Materials Program and mailed to the following address

Radioactive Materials Fees PO Box 101161

Atlanta GA 30392

Mail license applications and amendment requests to the following address

Radioactive Materials Program 4220 Internatronal ParkWay Suite 100

Atlanta GA ~0354

All license applications amendmentB and fee payments should be mailed the same day

Annual fees are billed by the Department at the beginning of each fiscal year

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 4 of 6 Pages License Number GA 1562middot1

Conditions (continued)

13 The Radiation Safety Officer in this program 9hall be Walter Holsl PharmD BeNP

14 A Licensed malarial shall be used by or under the supervision of

1) A pharmacist working or designated as an authorized nuclear pharmaclet in accordance with Rule 391-3-17-02(11)(i) or (Iv) or

2) Authorized nuclear pharmacist(s) Dave Abbott R Ph BCNP Adryl Addison Pharm D Chris Connell Pharm O Walter Holst Pharm 0 BeN John Michael Walker Pharm D Mark MUllinax Pharm D and Denny Sims Pharm O

B At least one Individual meeting the reqvlrements of this condition shall be physioally present at the authorized place of use whenever radioactive malerlalls being used

15 The licenseE shall perform required tests for leakage or contamination at intervals not to exceed six (6) months In accordance with Rule 391-3-17-03(6) Analysis of the tests shall be performed by persons specifically authorized by the Department the US Nuclear Regulatory Commission or an Agreement State to pelform such services

16 Sealed sources containing radioactive materi21 shall not beopened by Ihe licensee

17 The licensee shall conduct a physical Inventory every six months of sealed sources In accordance with Rule 391-S-17-05(33)(d

1S Any proposed changes In packagIng shielding or labeling shall be submitted for review to the Radioactive Materials Program Georgia Department of Natural Resources 4220 IntemaUonaJ Parkway Suite 100 Atlanta Georgia 30334 or present mailing address

19 The licensee is aulhorized to hold radioactive material with a physioal half-life of less than 120 days for decaymiddotinmiddotstorage before dispoBalln ordinary trash in accordance with Rule 391-3-17shy05(40

20 The licensee shall possess and use instrumentation to measure the radioaellvlly of radiopharmaceutlcals in accordance with Rvle 391middot3middot17-0211)(i)6

21 The licensee is authorized to retrieve receive and dispose of radioactive waste from Its customers limited to raciopharmacy supplied syringes and vials and Iheir components

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 5 of 6 Pages License Number GA 1582middot1

Conditions (continued)

22 A Radlon uclldes separated from a generator either by elution of a generator or by an extraction process shall be tesled to detect and quantify contaminant activity In accordance with Rule 391-3-17-05(45)(b

B Prior to first use of a generator the licensee shall establish written procedures for personnel performing lests to detect and quantify contaminants These procedures shall inolude all necessary calculations and steps to be taken If aotlvlUes of contaminants in excess of the limits specified In 391-3-17-05(45)(a) are detected

C Personnel performing tests to deleet and quantify contaminants shall be gIVen specific training in performing these tests prior 10 conductIng such tests

D 1 The licensee shall maintain for inspecUon by the Department records of the results of each test performed 10 detect and quantify contaminants and records of training given to personnel performing these tests

2 Records described In Subltem 01 above shall be maintained for three (3) years following the performance of the lasts and the training of personnel

23 The licensee shall not transfer possession andor control of materials or producls containing radioactive material as a contaminant except

A By transfer of waste 10 an authorized recipient

B By transfer to a specifically licensed recipient or

C As provided otherwise by a specific condition of this license pursuant to the requiremenls of (13) of Rule 391-3-17-03

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page (1 of 6 Pages LIcense Number GA 1582-1

ConditlOIlS (contInued)

24 In addition to the possession limits in Item 8 1he licensee shall further restrict the possession of licensed material with a half-life greater than 120 days to quantities lees than those specified In Rule 391middot3middot17028)(g)4 Exceeding quantities in 02(8(g4 requires 1he submittal of Ii financial assurance mechanism or a decommissioning funding plan

25 In addition to the p09sesslon limits in Item 8 the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in Rule 391-3shy1702(21)(e) Schedule E which requires consideration of the need for an emergency plan (02(7)(hraquo) for responding to a release of licensed material

26 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with statements representations and procedures contained in the documents Including any enclosures listed below

A Application with enclosures dated May 62008 and signed by William P McCormick Senior VP amp General Couneel

The Georgia Department of Natural Resources regulations shall govern Ltnless the statements representations and procedures in the licensees application and oorrespondence are mere restrictive than the Regulations

FOR THE OEPARTMENT OF NATURAL RESOURCES

Date June 13 2008 BY

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 4: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Adrryl Addison Triad Georgia RAM License New York BOP permit

Georgia Department of Natural Resources 4220 International Parkway Suite 100 Atlanta Georgia 30354

Noel tlolcomb CommisSioner Envlronmentlll (o~clkm Division

Catol A Couch pnDbull Ohectot (404) 3Glmiddot2676

RADIOACTive MATERIALS PROGRAM GEORGIA RADIOACTIVE MATERIALS LICENSE

Pursuenl to Iho Geor9ia Rlldialion Conlrol Act OCGA 31middot13 (HB 947) 1990 and tho Georgia Department of Naturlll Resources Rulegt IIlld Rcgulallons deslgnllted Chapler 391-3-171 end In tellanco on stalemant end roprosonlaUons herelofor~ mlldo by tho lioeneaa designated below iii license is hereby lsaued luthllri2lng luch licen810 10 transfer receive P01l611116 and ule the radlotKllve malarlal(s) designated below anD 10 use suell ntdloBclve ma1erlals for tile purpOS1J(II) and et Ihft pla~($) designated below Thill license 19 subject 10 al applicable rults lind regulallons of 1he Georgia Department or Natural ResouIC6t1 and olders luuod by 1I1i Department now orhereaIter in etrecl anCllo any condition 8pCifled below

Page 1of 6 Pages License Number GA 1582-1

License (1 Name and 2 Address) 3 In accordance wllh application dated May 6 2008 License Number GA

triad Isotopes Inc 1~82middot1 Is Issued to read aa follows dba Nuclear Pharmacy of Georgia 200 South Orange Avenue Suite 2100 4 Expiration Date June 30 2013 Orlando Florida 32B01

5 Telephone Numbr 407455middot6700 Norcross Number 6781242-1870

6 RADIOACTiVe MATERIAL 7 CHEMICAL ANDOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANYONE

TIME

A Any radloaotlve material wlth A Any A Not to exceed SOD atomiG numbers 1 throllgh 83 millicurie~ per except molybdenum 99 radionuclide and 2 Curie technetium 99m iodine 131 total xenon 133 and thallium 201

B Any radloaotlve material 8 Any 8 35 CurIes authorized in (41) of Rule 3913shy17-05 except iodine 131 and technetium 99m

C Any radioactive material C Any C 35 Curies authorized In (48) of Rule 391middot3shy7-05

D Iodine 131 D Any form except $ealed D 2 Curiee source

C Molybdenum 99 e Any E 35 Curies

F Technetium gem F Anyforrn except sealed F 25 Curies source

Georgia Department of Natnral Resources Radioactive Materials License

Supplementary Sheet

Page 2 of 6 Pages license Number GA 1562middot1

6 RADIOACTIVE MATERIAL T CHEMICAl ANDIOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANY ONE

TIME

G Xenon 133 G UnIt dose containers G 1 Curle

H Yttrium SO H Liquid H 110 millicuries no standard to exceed 52 mllliollries

I Iodine 125 I Meta-iodobenzl guanidine I 100 millicuries

J IOdlne-131 Bexxar J 1-131 Tosllumomab J 500 mllllcurtes

K Samariummiddot153 K Samarium Lexidronam K 500 millicuries

L Strontium 89 L Strontium Chloride L 500 mlllicuries

M Any radloacllve malerial M Prepackaged In vitro M 100 mllllourlee Identified in (6)(g)1 of Rule 391- diagnostic test kits 3middot17middot02

N Any radioactive material N Any N 30 mllUcuries 15 mCi for authOrized by (32) of Rule 391middot halfmiddotllfe pound 120 days and 3-17-05 200CI for half~lire gt

120days

0 Iodine 125 O Sealed Source O 500 mllilourles

P Palladium 103 P Sealed Source P 500 millicurie

Q Depleted Uranium O Malal encased in stainless Q 101 kilograms steel

9 AUTHORizeD USE

A Redistribution of prepared radlopharmaceuticals to authorized recipients

B Preparing dispensing andor dIstribution of radlopharmaceutlcals to autholiled reCipients Use of technetIum 99m Pertechnetate for processing with reagent kits in preparing radlopharmacaullcals

C L Preparing dispensing andor distribution of radlopharmaceutioals to authoriced recipients

M Redistribution of prepackaged In vitro kits to general and specific licenses

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 3 of 6 Pages License Number GA 1582-1

N InslrumenteHon Calibration

o-P Sealed sources for brachytherapy or diagnosis to be redistributed will be obtained from a manufacturer authorzed 10 distribute sealed sources for brachytherapy or diagnosis according to a speCific license issued pursuant to 02(11)mmiddot

Q Shielding for molybdenum 991echnetium 99m generators

CONDITIONS

10 Radioactive materia shall be used only althe licensees facilities at 3100 Medlock Bridge Road Bulding 300 Suite 360 Norcross Georgia 30072

11 The licensee shall comply with the provisions of Georgia Department of Natural Resources Rule 391-3-17-03 Standards for Protection Against Radiation Amended Rule 391middot3-17-05 Use of Radlonuclides in the Healing Arts Amended Rule 391-3-17-06 Transportation of Radioactive Material Amended and Rule 391-3-17-07 Notice Instructions end Reports to Workers Inspections Amended

12 In accordance with DNR Board Policy adopted May 28 2003 the fees associated with this license fee category A8a are

Application fee $340000 Annual fee $458000 Amendment fee $46000 Non-routine Inspection fee $190000

Checks for the fees should be made payable to the Department of Natural Resources Radioaotive Materials Program and mailed to the following address

Radioactive Materials Fees PO Box 101161

Atlanta GA 30392

Mail license applications and amendment requests to the following address

Radioactive Materials Program 4220 Internatronal ParkWay Suite 100

Atlanta GA ~0354

All license applications amendmentB and fee payments should be mailed the same day

Annual fees are billed by the Department at the beginning of each fiscal year

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 4 of 6 Pages License Number GA 1562middot1

Conditions (continued)

13 The Radiation Safety Officer in this program 9hall be Walter Holsl PharmD BeNP

14 A Licensed malarial shall be used by or under the supervision of

1) A pharmacist working or designated as an authorized nuclear pharmaclet in accordance with Rule 391-3-17-02(11)(i) or (Iv) or

2) Authorized nuclear pharmacist(s) Dave Abbott R Ph BCNP Adryl Addison Pharm D Chris Connell Pharm O Walter Holst Pharm 0 BeN John Michael Walker Pharm D Mark MUllinax Pharm D and Denny Sims Pharm O

B At least one Individual meeting the reqvlrements of this condition shall be physioally present at the authorized place of use whenever radioactive malerlalls being used

15 The licenseE shall perform required tests for leakage or contamination at intervals not to exceed six (6) months In accordance with Rule 391-3-17-03(6) Analysis of the tests shall be performed by persons specifically authorized by the Department the US Nuclear Regulatory Commission or an Agreement State to pelform such services

16 Sealed sources containing radioactive materi21 shall not beopened by Ihe licensee

17 The licensee shall conduct a physical Inventory every six months of sealed sources In accordance with Rule 391-S-17-05(33)(d

1S Any proposed changes In packagIng shielding or labeling shall be submitted for review to the Radioactive Materials Program Georgia Department of Natural Resources 4220 IntemaUonaJ Parkway Suite 100 Atlanta Georgia 30334 or present mailing address

19 The licensee is aulhorized to hold radioactive material with a physioal half-life of less than 120 days for decaymiddotinmiddotstorage before dispoBalln ordinary trash in accordance with Rule 391-3-17shy05(40

20 The licensee shall possess and use instrumentation to measure the radioaellvlly of radiopharmaceutlcals in accordance with Rvle 391middot3middot17-0211)(i)6

21 The licensee is authorized to retrieve receive and dispose of radioactive waste from Its customers limited to raciopharmacy supplied syringes and vials and Iheir components

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 5 of 6 Pages License Number GA 1582middot1

Conditions (continued)

22 A Radlon uclldes separated from a generator either by elution of a generator or by an extraction process shall be tesled to detect and quantify contaminant activity In accordance with Rule 391-3-17-05(45)(b

B Prior to first use of a generator the licensee shall establish written procedures for personnel performing lests to detect and quantify contaminants These procedures shall inolude all necessary calculations and steps to be taken If aotlvlUes of contaminants in excess of the limits specified In 391-3-17-05(45)(a) are detected

C Personnel performing tests to deleet and quantify contaminants shall be gIVen specific training in performing these tests prior 10 conductIng such tests

D 1 The licensee shall maintain for inspecUon by the Department records of the results of each test performed 10 detect and quantify contaminants and records of training given to personnel performing these tests

2 Records described In Subltem 01 above shall be maintained for three (3) years following the performance of the lasts and the training of personnel

23 The licensee shall not transfer possession andor control of materials or producls containing radioactive material as a contaminant except

A By transfer of waste 10 an authorized recipient

B By transfer to a specifically licensed recipient or

C As provided otherwise by a specific condition of this license pursuant to the requiremenls of (13) of Rule 391-3-17-03

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page (1 of 6 Pages LIcense Number GA 1582-1

ConditlOIlS (contInued)

24 In addition to the possession limits in Item 8 1he licensee shall further restrict the possession of licensed material with a half-life greater than 120 days to quantities lees than those specified In Rule 391middot3middot17028)(g)4 Exceeding quantities in 02(8(g4 requires 1he submittal of Ii financial assurance mechanism or a decommissioning funding plan

25 In addition to the p09sesslon limits in Item 8 the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in Rule 391-3shy1702(21)(e) Schedule E which requires consideration of the need for an emergency plan (02(7)(hraquo) for responding to a release of licensed material

26 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with statements representations and procedures contained in the documents Including any enclosures listed below

A Application with enclosures dated May 62008 and signed by William P McCormick Senior VP amp General Couneel

The Georgia Department of Natural Resources regulations shall govern Ltnless the statements representations and procedures in the licensees application and oorrespondence are mere restrictive than the Regulations

FOR THE OEPARTMENT OF NATURAL RESOURCES

Date June 13 2008 BY

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 5: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Georgia Department of Natural Resources 4220 International Parkway Suite 100 Atlanta Georgia 30354

Noel tlolcomb CommisSioner Envlronmentlll (o~clkm Division

Catol A Couch pnDbull Ohectot (404) 3Glmiddot2676

RADIOACTive MATERIALS PROGRAM GEORGIA RADIOACTIVE MATERIALS LICENSE

Pursuenl to Iho Geor9ia Rlldialion Conlrol Act OCGA 31middot13 (HB 947) 1990 and tho Georgia Department of Naturlll Resources Rulegt IIlld Rcgulallons deslgnllted Chapler 391-3-171 end In tellanco on stalemant end roprosonlaUons herelofor~ mlldo by tho lioeneaa designated below iii license is hereby lsaued luthllri2lng luch licen810 10 transfer receive P01l611116 and ule the radlotKllve malarlal(s) designated below anD 10 use suell ntdloBclve ma1erlals for tile purpOS1J(II) and et Ihft pla~($) designated below Thill license 19 subject 10 al applicable rults lind regulallons of 1he Georgia Department or Natural ResouIC6t1 and olders luuod by 1I1i Department now orhereaIter in etrecl anCllo any condition 8pCifled below

Page 1of 6 Pages License Number GA 1582-1

License (1 Name and 2 Address) 3 In accordance wllh application dated May 6 2008 License Number GA

triad Isotopes Inc 1~82middot1 Is Issued to read aa follows dba Nuclear Pharmacy of Georgia 200 South Orange Avenue Suite 2100 4 Expiration Date June 30 2013 Orlando Florida 32B01

5 Telephone Numbr 407455middot6700 Norcross Number 6781242-1870

6 RADIOACTiVe MATERIAL 7 CHEMICAL ANDOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANYONE

TIME

A Any radloaotlve material wlth A Any A Not to exceed SOD atomiG numbers 1 throllgh 83 millicurie~ per except molybdenum 99 radionuclide and 2 Curie technetium 99m iodine 131 total xenon 133 and thallium 201

B Any radloaotlve material 8 Any 8 35 CurIes authorized in (41) of Rule 3913shy17-05 except iodine 131 and technetium 99m

C Any radioactive material C Any C 35 Curies authorized In (48) of Rule 391middot3shy7-05

D Iodine 131 D Any form except $ealed D 2 Curiee source

C Molybdenum 99 e Any E 35 Curies

F Technetium gem F Anyforrn except sealed F 25 Curies source

Georgia Department of Natnral Resources Radioactive Materials License

Supplementary Sheet

Page 2 of 6 Pages license Number GA 1562middot1

6 RADIOACTIVE MATERIAL T CHEMICAl ANDIOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANY ONE

TIME

G Xenon 133 G UnIt dose containers G 1 Curle

H Yttrium SO H Liquid H 110 millicuries no standard to exceed 52 mllliollries

I Iodine 125 I Meta-iodobenzl guanidine I 100 millicuries

J IOdlne-131 Bexxar J 1-131 Tosllumomab J 500 mllllcurtes

K Samariummiddot153 K Samarium Lexidronam K 500 millicuries

L Strontium 89 L Strontium Chloride L 500 mlllicuries

M Any radloacllve malerial M Prepackaged In vitro M 100 mllllourlee Identified in (6)(g)1 of Rule 391- diagnostic test kits 3middot17middot02

N Any radioactive material N Any N 30 mllUcuries 15 mCi for authOrized by (32) of Rule 391middot halfmiddotllfe pound 120 days and 3-17-05 200CI for half~lire gt

120days

0 Iodine 125 O Sealed Source O 500 mllilourles

P Palladium 103 P Sealed Source P 500 millicurie

Q Depleted Uranium O Malal encased in stainless Q 101 kilograms steel

9 AUTHORizeD USE

A Redistribution of prepared radlopharmaceuticals to authorized recipients

B Preparing dispensing andor dIstribution of radlopharmaceutlcals to autholiled reCipients Use of technetIum 99m Pertechnetate for processing with reagent kits in preparing radlopharmacaullcals

C L Preparing dispensing andor distribution of radlopharmaceutioals to authoriced recipients

M Redistribution of prepackaged In vitro kits to general and specific licenses

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 3 of 6 Pages License Number GA 1582-1

N InslrumenteHon Calibration

o-P Sealed sources for brachytherapy or diagnosis to be redistributed will be obtained from a manufacturer authorzed 10 distribute sealed sources for brachytherapy or diagnosis according to a speCific license issued pursuant to 02(11)mmiddot

Q Shielding for molybdenum 991echnetium 99m generators

CONDITIONS

10 Radioactive materia shall be used only althe licensees facilities at 3100 Medlock Bridge Road Bulding 300 Suite 360 Norcross Georgia 30072

11 The licensee shall comply with the provisions of Georgia Department of Natural Resources Rule 391-3-17-03 Standards for Protection Against Radiation Amended Rule 391middot3-17-05 Use of Radlonuclides in the Healing Arts Amended Rule 391-3-17-06 Transportation of Radioactive Material Amended and Rule 391-3-17-07 Notice Instructions end Reports to Workers Inspections Amended

12 In accordance with DNR Board Policy adopted May 28 2003 the fees associated with this license fee category A8a are

Application fee $340000 Annual fee $458000 Amendment fee $46000 Non-routine Inspection fee $190000

Checks for the fees should be made payable to the Department of Natural Resources Radioaotive Materials Program and mailed to the following address

Radioactive Materials Fees PO Box 101161

Atlanta GA 30392

Mail license applications and amendment requests to the following address

Radioactive Materials Program 4220 Internatronal ParkWay Suite 100

Atlanta GA ~0354

All license applications amendmentB and fee payments should be mailed the same day

Annual fees are billed by the Department at the beginning of each fiscal year

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 4 of 6 Pages License Number GA 1562middot1

Conditions (continued)

13 The Radiation Safety Officer in this program 9hall be Walter Holsl PharmD BeNP

14 A Licensed malarial shall be used by or under the supervision of

1) A pharmacist working or designated as an authorized nuclear pharmaclet in accordance with Rule 391-3-17-02(11)(i) or (Iv) or

2) Authorized nuclear pharmacist(s) Dave Abbott R Ph BCNP Adryl Addison Pharm D Chris Connell Pharm O Walter Holst Pharm 0 BeN John Michael Walker Pharm D Mark MUllinax Pharm D and Denny Sims Pharm O

B At least one Individual meeting the reqvlrements of this condition shall be physioally present at the authorized place of use whenever radioactive malerlalls being used

15 The licenseE shall perform required tests for leakage or contamination at intervals not to exceed six (6) months In accordance with Rule 391-3-17-03(6) Analysis of the tests shall be performed by persons specifically authorized by the Department the US Nuclear Regulatory Commission or an Agreement State to pelform such services

16 Sealed sources containing radioactive materi21 shall not beopened by Ihe licensee

17 The licensee shall conduct a physical Inventory every six months of sealed sources In accordance with Rule 391-S-17-05(33)(d

1S Any proposed changes In packagIng shielding or labeling shall be submitted for review to the Radioactive Materials Program Georgia Department of Natural Resources 4220 IntemaUonaJ Parkway Suite 100 Atlanta Georgia 30334 or present mailing address

19 The licensee is aulhorized to hold radioactive material with a physioal half-life of less than 120 days for decaymiddotinmiddotstorage before dispoBalln ordinary trash in accordance with Rule 391-3-17shy05(40

20 The licensee shall possess and use instrumentation to measure the radioaellvlly of radiopharmaceutlcals in accordance with Rvle 391middot3middot17-0211)(i)6

21 The licensee is authorized to retrieve receive and dispose of radioactive waste from Its customers limited to raciopharmacy supplied syringes and vials and Iheir components

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 5 of 6 Pages License Number GA 1582middot1

Conditions (continued)

22 A Radlon uclldes separated from a generator either by elution of a generator or by an extraction process shall be tesled to detect and quantify contaminant activity In accordance with Rule 391-3-17-05(45)(b

B Prior to first use of a generator the licensee shall establish written procedures for personnel performing lests to detect and quantify contaminants These procedures shall inolude all necessary calculations and steps to be taken If aotlvlUes of contaminants in excess of the limits specified In 391-3-17-05(45)(a) are detected

C Personnel performing tests to deleet and quantify contaminants shall be gIVen specific training in performing these tests prior 10 conductIng such tests

D 1 The licensee shall maintain for inspecUon by the Department records of the results of each test performed 10 detect and quantify contaminants and records of training given to personnel performing these tests

2 Records described In Subltem 01 above shall be maintained for three (3) years following the performance of the lasts and the training of personnel

23 The licensee shall not transfer possession andor control of materials or producls containing radioactive material as a contaminant except

A By transfer of waste 10 an authorized recipient

B By transfer to a specifically licensed recipient or

C As provided otherwise by a specific condition of this license pursuant to the requiremenls of (13) of Rule 391-3-17-03

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page (1 of 6 Pages LIcense Number GA 1582-1

ConditlOIlS (contInued)

24 In addition to the possession limits in Item 8 1he licensee shall further restrict the possession of licensed material with a half-life greater than 120 days to quantities lees than those specified In Rule 391middot3middot17028)(g)4 Exceeding quantities in 02(8(g4 requires 1he submittal of Ii financial assurance mechanism or a decommissioning funding plan

25 In addition to the p09sesslon limits in Item 8 the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in Rule 391-3shy1702(21)(e) Schedule E which requires consideration of the need for an emergency plan (02(7)(hraquo) for responding to a release of licensed material

26 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with statements representations and procedures contained in the documents Including any enclosures listed below

A Application with enclosures dated May 62008 and signed by William P McCormick Senior VP amp General Couneel

The Georgia Department of Natural Resources regulations shall govern Ltnless the statements representations and procedures in the licensees application and oorrespondence are mere restrictive than the Regulations

FOR THE OEPARTMENT OF NATURAL RESOURCES

Date June 13 2008 BY

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 6: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Georgia Department of Natnral Resources Radioactive Materials License

Supplementary Sheet

Page 2 of 6 Pages license Number GA 1562middot1

6 RADIOACTIVE MATERIAL T CHEMICAl ANDIOR 8 MAXIMUM QUANTITY (ELEMENT AND MASS PHYSICAL FORM LICENSEE MAY NUMBER) POSSESS AT ANY ONE

TIME

G Xenon 133 G UnIt dose containers G 1 Curle

H Yttrium SO H Liquid H 110 millicuries no standard to exceed 52 mllliollries

I Iodine 125 I Meta-iodobenzl guanidine I 100 millicuries

J IOdlne-131 Bexxar J 1-131 Tosllumomab J 500 mllllcurtes

K Samariummiddot153 K Samarium Lexidronam K 500 millicuries

L Strontium 89 L Strontium Chloride L 500 mlllicuries

M Any radloacllve malerial M Prepackaged In vitro M 100 mllllourlee Identified in (6)(g)1 of Rule 391- diagnostic test kits 3middot17middot02

N Any radioactive material N Any N 30 mllUcuries 15 mCi for authOrized by (32) of Rule 391middot halfmiddotllfe pound 120 days and 3-17-05 200CI for half~lire gt

120days

0 Iodine 125 O Sealed Source O 500 mllilourles

P Palladium 103 P Sealed Source P 500 millicurie

Q Depleted Uranium O Malal encased in stainless Q 101 kilograms steel

9 AUTHORizeD USE

A Redistribution of prepared radlopharmaceuticals to authorized recipients

B Preparing dispensing andor dIstribution of radlopharmaceutlcals to autholiled reCipients Use of technetIum 99m Pertechnetate for processing with reagent kits in preparing radlopharmacaullcals

C L Preparing dispensing andor distribution of radlopharmaceutioals to authoriced recipients

M Redistribution of prepackaged In vitro kits to general and specific licenses

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 3 of 6 Pages License Number GA 1582-1

N InslrumenteHon Calibration

o-P Sealed sources for brachytherapy or diagnosis to be redistributed will be obtained from a manufacturer authorzed 10 distribute sealed sources for brachytherapy or diagnosis according to a speCific license issued pursuant to 02(11)mmiddot

Q Shielding for molybdenum 991echnetium 99m generators

CONDITIONS

10 Radioactive materia shall be used only althe licensees facilities at 3100 Medlock Bridge Road Bulding 300 Suite 360 Norcross Georgia 30072

11 The licensee shall comply with the provisions of Georgia Department of Natural Resources Rule 391-3-17-03 Standards for Protection Against Radiation Amended Rule 391middot3-17-05 Use of Radlonuclides in the Healing Arts Amended Rule 391-3-17-06 Transportation of Radioactive Material Amended and Rule 391-3-17-07 Notice Instructions end Reports to Workers Inspections Amended

12 In accordance with DNR Board Policy adopted May 28 2003 the fees associated with this license fee category A8a are

Application fee $340000 Annual fee $458000 Amendment fee $46000 Non-routine Inspection fee $190000

Checks for the fees should be made payable to the Department of Natural Resources Radioaotive Materials Program and mailed to the following address

Radioactive Materials Fees PO Box 101161

Atlanta GA 30392

Mail license applications and amendment requests to the following address

Radioactive Materials Program 4220 Internatronal ParkWay Suite 100

Atlanta GA ~0354

All license applications amendmentB and fee payments should be mailed the same day

Annual fees are billed by the Department at the beginning of each fiscal year

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 4 of 6 Pages License Number GA 1562middot1

Conditions (continued)

13 The Radiation Safety Officer in this program 9hall be Walter Holsl PharmD BeNP

14 A Licensed malarial shall be used by or under the supervision of

1) A pharmacist working or designated as an authorized nuclear pharmaclet in accordance with Rule 391-3-17-02(11)(i) or (Iv) or

2) Authorized nuclear pharmacist(s) Dave Abbott R Ph BCNP Adryl Addison Pharm D Chris Connell Pharm O Walter Holst Pharm 0 BeN John Michael Walker Pharm D Mark MUllinax Pharm D and Denny Sims Pharm O

B At least one Individual meeting the reqvlrements of this condition shall be physioally present at the authorized place of use whenever radioactive malerlalls being used

15 The licenseE shall perform required tests for leakage or contamination at intervals not to exceed six (6) months In accordance with Rule 391-3-17-03(6) Analysis of the tests shall be performed by persons specifically authorized by the Department the US Nuclear Regulatory Commission or an Agreement State to pelform such services

16 Sealed sources containing radioactive materi21 shall not beopened by Ihe licensee

17 The licensee shall conduct a physical Inventory every six months of sealed sources In accordance with Rule 391-S-17-05(33)(d

1S Any proposed changes In packagIng shielding or labeling shall be submitted for review to the Radioactive Materials Program Georgia Department of Natural Resources 4220 IntemaUonaJ Parkway Suite 100 Atlanta Georgia 30334 or present mailing address

19 The licensee is aulhorized to hold radioactive material with a physioal half-life of less than 120 days for decaymiddotinmiddotstorage before dispoBalln ordinary trash in accordance with Rule 391-3-17shy05(40

20 The licensee shall possess and use instrumentation to measure the radioaellvlly of radiopharmaceutlcals in accordance with Rvle 391middot3middot17-0211)(i)6

21 The licensee is authorized to retrieve receive and dispose of radioactive waste from Its customers limited to raciopharmacy supplied syringes and vials and Iheir components

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 5 of 6 Pages License Number GA 1582middot1

Conditions (continued)

22 A Radlon uclldes separated from a generator either by elution of a generator or by an extraction process shall be tesled to detect and quantify contaminant activity In accordance with Rule 391-3-17-05(45)(b

B Prior to first use of a generator the licensee shall establish written procedures for personnel performing lests to detect and quantify contaminants These procedures shall inolude all necessary calculations and steps to be taken If aotlvlUes of contaminants in excess of the limits specified In 391-3-17-05(45)(a) are detected

C Personnel performing tests to deleet and quantify contaminants shall be gIVen specific training in performing these tests prior 10 conductIng such tests

D 1 The licensee shall maintain for inspecUon by the Department records of the results of each test performed 10 detect and quantify contaminants and records of training given to personnel performing these tests

2 Records described In Subltem 01 above shall be maintained for three (3) years following the performance of the lasts and the training of personnel

23 The licensee shall not transfer possession andor control of materials or producls containing radioactive material as a contaminant except

A By transfer of waste 10 an authorized recipient

B By transfer to a specifically licensed recipient or

C As provided otherwise by a specific condition of this license pursuant to the requiremenls of (13) of Rule 391-3-17-03

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page (1 of 6 Pages LIcense Number GA 1582-1

ConditlOIlS (contInued)

24 In addition to the possession limits in Item 8 1he licensee shall further restrict the possession of licensed material with a half-life greater than 120 days to quantities lees than those specified In Rule 391middot3middot17028)(g)4 Exceeding quantities in 02(8(g4 requires 1he submittal of Ii financial assurance mechanism or a decommissioning funding plan

25 In addition to the p09sesslon limits in Item 8 the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in Rule 391-3shy1702(21)(e) Schedule E which requires consideration of the need for an emergency plan (02(7)(hraquo) for responding to a release of licensed material

26 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with statements representations and procedures contained in the documents Including any enclosures listed below

A Application with enclosures dated May 62008 and signed by William P McCormick Senior VP amp General Couneel

The Georgia Department of Natural Resources regulations shall govern Ltnless the statements representations and procedures in the licensees application and oorrespondence are mere restrictive than the Regulations

FOR THE OEPARTMENT OF NATURAL RESOURCES

Date June 13 2008 BY

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 7: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 3 of 6 Pages License Number GA 1582-1

N InslrumenteHon Calibration

o-P Sealed sources for brachytherapy or diagnosis to be redistributed will be obtained from a manufacturer authorzed 10 distribute sealed sources for brachytherapy or diagnosis according to a speCific license issued pursuant to 02(11)mmiddot

Q Shielding for molybdenum 991echnetium 99m generators

CONDITIONS

10 Radioactive materia shall be used only althe licensees facilities at 3100 Medlock Bridge Road Bulding 300 Suite 360 Norcross Georgia 30072

11 The licensee shall comply with the provisions of Georgia Department of Natural Resources Rule 391-3-17-03 Standards for Protection Against Radiation Amended Rule 391middot3-17-05 Use of Radlonuclides in the Healing Arts Amended Rule 391-3-17-06 Transportation of Radioactive Material Amended and Rule 391-3-17-07 Notice Instructions end Reports to Workers Inspections Amended

12 In accordance with DNR Board Policy adopted May 28 2003 the fees associated with this license fee category A8a are

Application fee $340000 Annual fee $458000 Amendment fee $46000 Non-routine Inspection fee $190000

Checks for the fees should be made payable to the Department of Natural Resources Radioaotive Materials Program and mailed to the following address

Radioactive Materials Fees PO Box 101161

Atlanta GA 30392

Mail license applications and amendment requests to the following address

Radioactive Materials Program 4220 Internatronal ParkWay Suite 100

Atlanta GA ~0354

All license applications amendmentB and fee payments should be mailed the same day

Annual fees are billed by the Department at the beginning of each fiscal year

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 4 of 6 Pages License Number GA 1562middot1

Conditions (continued)

13 The Radiation Safety Officer in this program 9hall be Walter Holsl PharmD BeNP

14 A Licensed malarial shall be used by or under the supervision of

1) A pharmacist working or designated as an authorized nuclear pharmaclet in accordance with Rule 391-3-17-02(11)(i) or (Iv) or

2) Authorized nuclear pharmacist(s) Dave Abbott R Ph BCNP Adryl Addison Pharm D Chris Connell Pharm O Walter Holst Pharm 0 BeN John Michael Walker Pharm D Mark MUllinax Pharm D and Denny Sims Pharm O

B At least one Individual meeting the reqvlrements of this condition shall be physioally present at the authorized place of use whenever radioactive malerlalls being used

15 The licenseE shall perform required tests for leakage or contamination at intervals not to exceed six (6) months In accordance with Rule 391-3-17-03(6) Analysis of the tests shall be performed by persons specifically authorized by the Department the US Nuclear Regulatory Commission or an Agreement State to pelform such services

16 Sealed sources containing radioactive materi21 shall not beopened by Ihe licensee

17 The licensee shall conduct a physical Inventory every six months of sealed sources In accordance with Rule 391-S-17-05(33)(d

1S Any proposed changes In packagIng shielding or labeling shall be submitted for review to the Radioactive Materials Program Georgia Department of Natural Resources 4220 IntemaUonaJ Parkway Suite 100 Atlanta Georgia 30334 or present mailing address

19 The licensee is aulhorized to hold radioactive material with a physioal half-life of less than 120 days for decaymiddotinmiddotstorage before dispoBalln ordinary trash in accordance with Rule 391-3-17shy05(40

20 The licensee shall possess and use instrumentation to measure the radioaellvlly of radiopharmaceutlcals in accordance with Rvle 391middot3middot17-0211)(i)6

21 The licensee is authorized to retrieve receive and dispose of radioactive waste from Its customers limited to raciopharmacy supplied syringes and vials and Iheir components

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 5 of 6 Pages License Number GA 1582middot1

Conditions (continued)

22 A Radlon uclldes separated from a generator either by elution of a generator or by an extraction process shall be tesled to detect and quantify contaminant activity In accordance with Rule 391-3-17-05(45)(b

B Prior to first use of a generator the licensee shall establish written procedures for personnel performing lests to detect and quantify contaminants These procedures shall inolude all necessary calculations and steps to be taken If aotlvlUes of contaminants in excess of the limits specified In 391-3-17-05(45)(a) are detected

C Personnel performing tests to deleet and quantify contaminants shall be gIVen specific training in performing these tests prior 10 conductIng such tests

D 1 The licensee shall maintain for inspecUon by the Department records of the results of each test performed 10 detect and quantify contaminants and records of training given to personnel performing these tests

2 Records described In Subltem 01 above shall be maintained for three (3) years following the performance of the lasts and the training of personnel

23 The licensee shall not transfer possession andor control of materials or producls containing radioactive material as a contaminant except

A By transfer of waste 10 an authorized recipient

B By transfer to a specifically licensed recipient or

C As provided otherwise by a specific condition of this license pursuant to the requiremenls of (13) of Rule 391-3-17-03

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page (1 of 6 Pages LIcense Number GA 1582-1

ConditlOIlS (contInued)

24 In addition to the possession limits in Item 8 1he licensee shall further restrict the possession of licensed material with a half-life greater than 120 days to quantities lees than those specified In Rule 391middot3middot17028)(g)4 Exceeding quantities in 02(8(g4 requires 1he submittal of Ii financial assurance mechanism or a decommissioning funding plan

25 In addition to the p09sesslon limits in Item 8 the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in Rule 391-3shy1702(21)(e) Schedule E which requires consideration of the need for an emergency plan (02(7)(hraquo) for responding to a release of licensed material

26 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with statements representations and procedures contained in the documents Including any enclosures listed below

A Application with enclosures dated May 62008 and signed by William P McCormick Senior VP amp General Couneel

The Georgia Department of Natural Resources regulations shall govern Ltnless the statements representations and procedures in the licensees application and oorrespondence are mere restrictive than the Regulations

FOR THE OEPARTMENT OF NATURAL RESOURCES

Date June 13 2008 BY

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 8: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 4 of 6 Pages License Number GA 1562middot1

Conditions (continued)

13 The Radiation Safety Officer in this program 9hall be Walter Holsl PharmD BeNP

14 A Licensed malarial shall be used by or under the supervision of

1) A pharmacist working or designated as an authorized nuclear pharmaclet in accordance with Rule 391-3-17-02(11)(i) or (Iv) or

2) Authorized nuclear pharmacist(s) Dave Abbott R Ph BCNP Adryl Addison Pharm D Chris Connell Pharm O Walter Holst Pharm 0 BeN John Michael Walker Pharm D Mark MUllinax Pharm D and Denny Sims Pharm O

B At least one Individual meeting the reqvlrements of this condition shall be physioally present at the authorized place of use whenever radioactive malerlalls being used

15 The licenseE shall perform required tests for leakage or contamination at intervals not to exceed six (6) months In accordance with Rule 391-3-17-03(6) Analysis of the tests shall be performed by persons specifically authorized by the Department the US Nuclear Regulatory Commission or an Agreement State to pelform such services

16 Sealed sources containing radioactive materi21 shall not beopened by Ihe licensee

17 The licensee shall conduct a physical Inventory every six months of sealed sources In accordance with Rule 391-S-17-05(33)(d

1S Any proposed changes In packagIng shielding or labeling shall be submitted for review to the Radioactive Materials Program Georgia Department of Natural Resources 4220 IntemaUonaJ Parkway Suite 100 Atlanta Georgia 30334 or present mailing address

19 The licensee is aulhorized to hold radioactive material with a physioal half-life of less than 120 days for decaymiddotinmiddotstorage before dispoBalln ordinary trash in accordance with Rule 391-3-17shy05(40

20 The licensee shall possess and use instrumentation to measure the radioaellvlly of radiopharmaceutlcals in accordance with Rvle 391middot3middot17-0211)(i)6

21 The licensee is authorized to retrieve receive and dispose of radioactive waste from Its customers limited to raciopharmacy supplied syringes and vials and Iheir components

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 5 of 6 Pages License Number GA 1582middot1

Conditions (continued)

22 A Radlon uclldes separated from a generator either by elution of a generator or by an extraction process shall be tesled to detect and quantify contaminant activity In accordance with Rule 391-3-17-05(45)(b

B Prior to first use of a generator the licensee shall establish written procedures for personnel performing lests to detect and quantify contaminants These procedures shall inolude all necessary calculations and steps to be taken If aotlvlUes of contaminants in excess of the limits specified In 391-3-17-05(45)(a) are detected

C Personnel performing tests to deleet and quantify contaminants shall be gIVen specific training in performing these tests prior 10 conductIng such tests

D 1 The licensee shall maintain for inspecUon by the Department records of the results of each test performed 10 detect and quantify contaminants and records of training given to personnel performing these tests

2 Records described In Subltem 01 above shall be maintained for three (3) years following the performance of the lasts and the training of personnel

23 The licensee shall not transfer possession andor control of materials or producls containing radioactive material as a contaminant except

A By transfer of waste 10 an authorized recipient

B By transfer to a specifically licensed recipient or

C As provided otherwise by a specific condition of this license pursuant to the requiremenls of (13) of Rule 391-3-17-03

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page (1 of 6 Pages LIcense Number GA 1582-1

ConditlOIlS (contInued)

24 In addition to the possession limits in Item 8 1he licensee shall further restrict the possession of licensed material with a half-life greater than 120 days to quantities lees than those specified In Rule 391middot3middot17028)(g)4 Exceeding quantities in 02(8(g4 requires 1he submittal of Ii financial assurance mechanism or a decommissioning funding plan

25 In addition to the p09sesslon limits in Item 8 the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in Rule 391-3shy1702(21)(e) Schedule E which requires consideration of the need for an emergency plan (02(7)(hraquo) for responding to a release of licensed material

26 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with statements representations and procedures contained in the documents Including any enclosures listed below

A Application with enclosures dated May 62008 and signed by William P McCormick Senior VP amp General Couneel

The Georgia Department of Natural Resources regulations shall govern Ltnless the statements representations and procedures in the licensees application and oorrespondence are mere restrictive than the Regulations

FOR THE OEPARTMENT OF NATURAL RESOURCES

Date June 13 2008 BY

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 9: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page 5 of 6 Pages License Number GA 1582middot1

Conditions (continued)

22 A Radlon uclldes separated from a generator either by elution of a generator or by an extraction process shall be tesled to detect and quantify contaminant activity In accordance with Rule 391-3-17-05(45)(b

B Prior to first use of a generator the licensee shall establish written procedures for personnel performing lests to detect and quantify contaminants These procedures shall inolude all necessary calculations and steps to be taken If aotlvlUes of contaminants in excess of the limits specified In 391-3-17-05(45)(a) are detected

C Personnel performing tests to deleet and quantify contaminants shall be gIVen specific training in performing these tests prior 10 conductIng such tests

D 1 The licensee shall maintain for inspecUon by the Department records of the results of each test performed 10 detect and quantify contaminants and records of training given to personnel performing these tests

2 Records described In Subltem 01 above shall be maintained for three (3) years following the performance of the lasts and the training of personnel

23 The licensee shall not transfer possession andor control of materials or producls containing radioactive material as a contaminant except

A By transfer of waste 10 an authorized recipient

B By transfer to a specifically licensed recipient or

C As provided otherwise by a specific condition of this license pursuant to the requiremenls of (13) of Rule 391-3-17-03

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page (1 of 6 Pages LIcense Number GA 1582-1

ConditlOIlS (contInued)

24 In addition to the possession limits in Item 8 1he licensee shall further restrict the possession of licensed material with a half-life greater than 120 days to quantities lees than those specified In Rule 391middot3middot17028)(g)4 Exceeding quantities in 02(8(g4 requires 1he submittal of Ii financial assurance mechanism or a decommissioning funding plan

25 In addition to the p09sesslon limits in Item 8 the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in Rule 391-3shy1702(21)(e) Schedule E which requires consideration of the need for an emergency plan (02(7)(hraquo) for responding to a release of licensed material

26 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with statements representations and procedures contained in the documents Including any enclosures listed below

A Application with enclosures dated May 62008 and signed by William P McCormick Senior VP amp General Couneel

The Georgia Department of Natural Resources regulations shall govern Ltnless the statements representations and procedures in the licensees application and oorrespondence are mere restrictive than the Regulations

FOR THE OEPARTMENT OF NATURAL RESOURCES

Date June 13 2008 BY

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 10: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Georgia Department of Natural Resources Radioactive Materials License

Supplementary Sheet

Page (1 of 6 Pages LIcense Number GA 1582-1

ConditlOIlS (contInued)

24 In addition to the possession limits in Item 8 1he licensee shall further restrict the possession of licensed material with a half-life greater than 120 days to quantities lees than those specified In Rule 391middot3middot17028)(g)4 Exceeding quantities in 02(8(g4 requires 1he submittal of Ii financial assurance mechanism or a decommissioning funding plan

25 In addition to the p09sesslon limits in Item 8 the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in Rule 391-3shy1702(21)(e) Schedule E which requires consideration of the need for an emergency plan (02(7)(hraquo) for responding to a release of licensed material

26 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with statements representations and procedures contained in the documents Including any enclosures listed below

A Application with enclosures dated May 62008 and signed by William P McCormick Senior VP amp General Couneel

The Georgia Department of Natural Resources regulations shall govern Ltnless the statements representations and procedures in the licensees application and oorrespondence are mere restrictive than the Regulations

FOR THE OEPARTMENT OF NATURAL RESOURCES

Date June 13 2008 BY

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 11: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

To LicenseeIRegistrant

bull Please review the Registration Certificate below to be sure the infonnation on it is correct

+ If any of the infonnation is not correct please contact us Ilt OPREGFEEmaiJnysedgov or (518) 474-3811 Ext 410

bull If the infonnation is correct sign above the LicenseeJRegistrant block and please destroy any previous Registration Certificates you may have as certificates with incorrect infonnation are not valid lind should not be kept

bull Should yom address or name cbange please notify us as described on the reverse and a new certificate will be issued

UPON RECEIPT OF THIS REGISTRATION CERTIFICATE YOUR PREVIOUSLY ISSUED REGISTRATION CERTIFICATE IS NULL AND VOID PLEASE DESTROY THE PREVIOUSLY ISSUED REGISTRATION CERTIFICATE

SeE BACK FOR tMIORTANT INFORMATION

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 12: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Gary Almase IBA Virginia RAM License Virginia BOP permit

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 13: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH

RADIOACTIVE MATERIALS LICENSE

Underthe Code of Virginia Section 321-2293 and t2V AC5-481 Virginia Radiation Protection Regulations and in reliance on statements and representations made by the licensee a license is issued authorizing the licensee to receive acquire possess and transfer radioactive material designated below to use the material for the purpose(s) and at the pJace(s) designated below and to deliver or transfer the material to persons authorized to receive it in accordance with 12VAC5-48J Virginia Radiation Protection Regulations This license is subject to all applicable rules and orders of the Virginia Department of Health now or hereafter in effect and to any conditions specified below

Licensee Name and Address In accordance with letter dated October 292010 3 License Number 107-113-1

is hereby amended to read as follows

1 IBA Molecular North America Inc 4 Amendment No 2

2 21000 Atlantic Blvd 5 Expiration Date July 31 2013 Dulles VA 20166

6 Radioactive material 7 Chemical andor 8 Maximum amount of 9 Authorized Use physical fonn radioactive materials that

the licensee may possess at anyone time under this license

A Any radioactive A Any A 3 curies per A through F Preparation and material with atomic radionuclide total not to distribution or redistribution of numbers 1 through 83 exceed 8 curies per radioactive drugs including except other nucJ ides location of use compounding of iodine-131 and listed herein used and unused molybdenumshy

99technetium-99m and B Iodine-131 B Any B 6 curies rubidium-82strontium-82

generators to authorized C Flourine-18 C Any C 50 curies at each recipients for medical use in

location of use accordance with 12V AC5-481shyD Carbon-1I D Any D 4 euries 470] and for non-medical use to

authorized recipients E Oxygen-15 E Any E 4 curies

F lodine-124 F Any F 10 curies

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 14: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

G Pd-103 G Sealed source G No single source to G and H Redistribution of sealed exceed the maximum sources initially distributed by a amount listed on the manufacturer licensed pursuant to Sealed Source and 12VAC5-481-470 J Device Registry total Redistribution of sealed sources not to exceed 1000 that have been registered either millicuries with NRC under 10 CFR 32210

H Iodine-125 H Sealed sources H No single source to or with an Agreement State and have been distributed in

exceed the maximum amount listed on the Sealed Source and Device Registry total not to exceed 1000 millicuries

accordance with an NRC or Agreement State specific license authorizing distribution to persons specifically authorized by an NRC or Agreement State license to receive possess and use the devices

1 Any radioactive 1 Sealed source I No single source to 1 Calibration and checking of the material permitted by exceed the maximum licensees instruments 12VAC5-481-1830 amount listed on the Redistribution of sealed sources

Sealed Source and initially distributed by a Device Registry total manufacturer licensed pursuant to not to exceed 500 12VAC5-481-470 J millicuries

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at 100 Executive Drive Suites 3 4 6 7 and 100 Sterling Virginia and at the Medical College of Virginia 1200 East Marshall Street Suite B303 Richmond Virginia

11 The Radiation Safety Officer for this license is David Pellicciarini CHP

12 A Licensed material shall be used by or under the supervision of

(1) A pharmacist working or designated as an authorized nuclear phannacist in accordance with 12VAC5-481-470 12

(2) Authorized Nuclear Phannacists

David S Askew RPh William Boerger RPh Jeffrey Brannock RPh Hayden Parker Honeycutt PharmD Kelli Rae Myers PhamlD Nasrin Pourkiani PharmD Sarah Skeele PhannD Sally Duann Vanderslice RPh BCNP Henry Wielgosz RPh Serge Lyashchenko PharmD Gary Almase PharmD

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 15: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

30[4

RADIOACTIVE MATERIALS

B Licensed material limited to the handling of radioactive material produced by cyclotron operations and not including the preparation and redistribution of radioactive drugs may also be used by individuals who have received the training described in the letter dated August 21 2009 have been instructed in the licensees operation and emergency procedures and have been approved in writing by the Radiation Safety Oflicer

13 The licensee is authorized to transport licensed material in accordance with the provisions of Chapter 481 Part Xlll Transportation of Radioactive Material

14 This license does not authorize commercial distribution of licensed material to persons exempt from licensing pursuant to 12VAC5-481-400

15 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized

16 The licensee shall conduct a physical inventory every 6 months or at other intervals approved by VDH to account for all sources andor devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory

17 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiophannacy supplied syringes and vials and their contents

18 The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee

A Surveys the waste at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to detennine that its radioactivity cannot be distinguished from background

B Removes or obliterates all radiation labels except for radiation labels on materials that are within containers that will be managed as biomedical waste after they have been released fiom the licensee and

C Maintains a record of each such disposal pennitted under this license condition for three years The record must include the date of disposal the date on which the radioactive material was placed in storage the radionuclides disposed the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who perfom1ed the disposal

19 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 12VAC5-481-450 C for establishing decommissioning financial assurance

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 16: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Page4of4 License Number 107-113-1

RADIOACTIVE MATERIALS LICENSE Amendment No

20 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below Chapter 481 Virginia Radiation Protection Regulations shall govern unless the statements representations and procedures in the licensees application and cOlTespondence are more restrictive than the regUlations

A Application dated February 3 2003

B Letter dated July 222003

C Letter dated January 6 2005

D Letter dated April 62005

E Letter dated June 272006

F Letter dated July 24 2006

G Letter dated February 12 2007

H Letter dated March 192008

1 Letter dated December 10 2008

J Letters received April 162009

K Letter dated August 21 2009

L Letter dated June 28 2010

FOR THE VIRGINIA DEPARTMENT OF HEALTH

UbMc SIGNATURE DATE DIRECTOR RADIOACTIVE MATERIALS PROGRAM

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 17: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

COMMONWEALTH OF VIRGINIA DEPARTMENT OF HEALTH PROFESSIONS

Dianlle L Reynolds-Calle MD Director

Carotin D Juran Ex(ultill Dirtctor (804) 367-4456

BOARD OF PHARMACY Wf)J Mayland Drilpound Suil 3()(

Ridlllllmd fA 333-463 IIIIIImiddotdhrmiddotlmiddotilgillitlgolmiddotphamw()middot

Pharm~)cist License

Gary Thomas Almase

Expires Number 12312012 --__---=0202210242 bull

To Provide Intormation or File 3

Complaint About a Licensee Call 1-800-533-1560

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 18: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Shahnam Biglari IBA California RAM License California BOP permit

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 19: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

09262011 1315 FAX 9164407999 RADIOLOGIC HEALTH BRN~CH IiUUUUUI

State of Califomla-Healtl md Human Servlr ~gency California Department of Public Health

Page 1 of 6 pages RADIOACTIVE MATERIAL LICENSE

Pursuant to the Califorr fa ode ofReIulatlons Division 1 Title 17 Chapter 5 Subchapter 4 Group 2 Ucensing of Radioactive Material and in rillarlee on statemen s snd represetations heretofore made by the IicemH a license is hereby issued alJthorizing the licensee to receive use possess transfer O dispose of radioactive material listed below and to use such radioactive material for the purpose(s) Bnd at the psce(s) deSignated behw This lfceflse Is subject to all applicable rules regulations and orders of the California Department of Public Health now or hereafter In lffeCt and t) any standard or specific condition specified in this license

1 Licensee IBA Mo etular North America Inc 3 License Number 713143 Amendment Number 19

4 Expiration dete2 Address 5900~B ()hna Way

June 16 2013Gilroy C 95020 (2) Attention David Pt 1I~ciarjni CHP 5 Inspection agency Radiologic Health Branch

____________middot~C_o~~~o~rn~t~~~a~d_ia~ti~o~n~~_a_re_~~l~O~f_fi_c~er~________~______________~N~o~rt~h~_______________________

In response to the Mter witb attachments dated July 26 2011 signed by David W Pellicciarini CHP Vice President License Ntnber 7131-43 is hereby amended as follows

-6 Nuclide 7 Fonn 8 Possession Limit

A Any AA I Any radionumiddotl de with atomic L Total possession limit not to

numbers 1-8i (~xcept as isted exceed 2 CL below

2 Fluorine-I 8 2 Not to exceed 50 Ci

3 RlIbiditJm-8~ 3 Not to exceed 3 Ci

4 Strontium-82 4 Not to exceed 3 Ci

5 Strontium-85 S Not to exceed 6 Ci

6 Iodine-I 24 6 Not to exceed 990 mCi

7 Iodine-HI 7 Not to exceed 990 mC i

B Any rndionuclide lith atomi( B Sealed solid or liquid sources B Total possession limit not to numbers 1-83 manufactured in accordance with a exceed 200 mCL Each source not

specific license issued by the to exceed 20 mCL United States Nuclear Regulatory Commission an Agreement State or a Licensing State

C Fluorine-18 C- Any C Total not to exceed 50 Ci

D Any radionuclide w ith atomic D Cyclotron activation products D Total not to exceed 4 Ci number 3-83 incuIve

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 20: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

IflUV)UUIRADIOLOGIC HEALTH BRANCH09262011 1316 FAX 9164407999

State of CalifornlamiddotHeal h aod Human Servi Agency California Department of Public Health

Page 2 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number 12

9 Authorized Use

A Preparatin and dislribution of radioactive drugs including compounding of Iodine-I 23 125 and 131 and redistrbution of tlstd and unused Molybdenum-99Technetium-99m and Strontium-82Rubidium-82 generatm to authorized recipients in accordance with CCR Title 17 Section 302102 Preparation and distributilm of radicactive drugs and radiochemicals including compounding oflodine-123 125 and 131 and redistrihution ofuS(d and unused Molybdenum-99Technetium-99m generators and Strontium-82fRubidiumshy82 to 81middotthgtrized recipients for non-medical use Also labeling blood components analysis of labeled or taggedlblogical samples

B calibra ion and cheking afthe licensees instruments and provide quality assurance testing to persons license(i hy the US Nuclear Regulatory Commission an Agreement State or a Licensing State Redistrb ltion of selled sources initially distributed by a manufacturer licensed pursuant to 10 CFR 3274 or equivajllt Agreement State or Licensing State requirements to authorized recipients for medical or nonshymedicai llle Redislribution ofsealed sources that have been registered either with US Nuclear Regulatory Commi lsbn under 10 CPR 322l 0 or withan Agreement State or a Licensing State and have been distribure to persous specifically authorized by US Nuclear Regulatory Commission an Agreement State or a Liceming State to receive possess and use the devicessources

C Manufacturing of positron emitting radionuclides for distribution using Ion Beam Appl ications Cyclone 189 cyciotren

D For stOlage only

LICENSE CONDITIONS

10 Radioactive ma1enal shall hi used only at the following locations

(a) 5900-8 ObatE Way Gilroy CA (Excluding rhe area occupied by RML 6579-43)

(b) Radioactiwllaterial d~scrjbed in Subitem A of this license may be used at licensed clinics and hospitaJs as temporary 0 sites of the licensee for the purposes of packaging preparation distribution and redistribution of used and u med Stromium-82IRubidium-82 generators throughout the State of California except those areas under exclt sive federal jurisdiction

11 This license is s t~ect to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in tems 6 7 8 and 9 of this license The annual fee for this license is required by and computed in accordance witl Title 17 California Code of Regulations Sections 30230middot30232 and is also subject to an annual cost-of-Iiving 3(jmtment pursuant to Section 100425 of the California Health and Safety Code

12 (a) Radioactive material shnll be used by or under the supervision and in the physical presence of the following individuals

(l) Homan Ibrahim JaTar RPh

(2) Mark A Juarez RPh

(3) Akrarr ~ A Kitdani RPh

(4) Henry Wielgosz RPh

(5) Serge bullYmiddotlshchenko PhannD

(6) Shahnam Biglari ItPh

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 21: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

09262011 13 16 FAX 9164407999 UADIULUllL )fJALllf UKANLl1

California Department (If Public Health State of Callfomia-Heal h ilnd Human Serv Agency

Page 3 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 7131-43

Amendment Number

(7) Anymiddot )tter radlopharmacist registered by the California State Board of Phannacy and also listed on a speedlt license ohhe US Nuclear Regulatory Commission an Agreement State or a Licensing State for a maxitrmm period of 60 days

(b) The Cycktwn shall be operated by or under the supervision and in the physical presence of the following individuaL

(1) Tomny Sjarief (12) Robert Symons

(2) Frank Ierson (13) Eric Schreiner

(3) Edwarc Jacobs (14) Frery Perez

(4) Martin Mager (J 5) Cristen Garner

(5) Phili~p Brisard ( 16) Otto SGarcia Jr

(6) ThOll a~ J Seimer ( I 7) Otto Garcia Sf

(7) Robe1 E Hallgre1 (1S) Alba Perez

(8) Frank f Vraniak (19) Bobby Perez

(9) Sky Cui (20) Ahmed Baker

(10) AI Parn (21) Y ing Zhang

(II) Gary Kmny

13 Except as spec if ally provided otherwise by this license the licensee shall possess and use radioactive material described in IMn 6 7 8 and 9 of this license in accordance with the statements representations and procedures contained in be documerts listed below The Departments regulations shall govern unless the statements representations lOd procedures in the licensees application and correspondence are more restrictive than the regulations

(a) The new licnse applkation with attachments dated September 162002 the letters with attachments dated February ~ ~003 March 26 2003 the letter dated May 62003 and the letters with attachment dated May ~ 2003 and May 27 2003 all signed by C Joseph Harless CNMT Vice President Operations and Corporate Radiation )fiety Officer

(b) The letter itlt attachments dated April 9 2004 as modified by the letter with attachment dated May 27 2004 and the letters oth with attachments dated June 9 2004 June 16 2004 and June 29 2004 the letter dated July 7 2004 thl fax cover page with attachment dated July 8 2004 all signed by C Joseph Harless CNMT COIporate Radiation Safety Officer regarding effluent monitoring physical measurements the QC hood Sr-821Rb-82 generators and commercial distribution along with associated procedures and commitments

(c) TIle letter with attachllent dated January 6 2005 signed by C Joseph Harless CNMT Corporate Radiation Safety Officr regardhg temporary job sites for Strontium-82IRubidium-82 generators

(d) The letter Nith attachments dated August 9 2006 signed by Anwer Rizvi President regarding the appointme Ilt of a new Corporate Radiation Safety Officer

(e) The letter ith attachment dated April 13 2009 signed by Homan Ibrahim Jarrar RPh Radiation Safety Officer regwding the change from monthly to quarterly exchange for personnel monitoring devices for some employees ill certain jltb classifications

(f) In the leter with attachments dated May 8 2009 signed by David Pellicciarini CHP Vice President Regulatory ffairs and EHampS and the letter dated April 21 2009 signed by Anwer Rizvi President and the letters datnd April 13 2009 and June 3 2009 and the letter with attachment dated February 17 2009 all

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 22: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

09262011 1317 FAX 9164407999 RADIOLOGIC HEALTH BRANCH 19I UU50117

State of California-Healh clnd Human Se Agency California Department of Public Health

Page 4 of 6 pages

RADIOACTIVE MATERIAL LICENSE license Number 7131-43

Amendment Number 19

signed by j-Ioman Ibrahim Jarrar BCNP Radiation Safety Officer regarding the appointment of a new Corporate Radiation Stfety Officer along with a new corporate mailing address at 21000 Atlantic Blvd Dulles VA 201611 md the approval to use one vial reference source for Daily Dose Calibrator Checks with the use of F- J8 and II fla-133 source with the use ofl-13 L

(g) The letter with attachments dated April 11 2011 supplemented by the letter with attachment dated June 8 2011 bod ~igned by David W Pellicciarini CHP Vice President regarding the remodeling of the pharmacy with associated commitments and procedures

(h) The letter with attachments dated May 16 2011 signed by David W PeJlicciarini CHP Vice President and the Duties and F~esponsibilities and Delegation of AuthOrity Form dated September 9 2011 signed by David W Pellicciarini CHP Vice President and Mark R Juarez RPb regarding the appointment of the new Radiation Safety Officer

14 (a) The Corpcrae Radiation Safety Officer in tlis program shall be David Pellicciarini CHP (b) The Radiaion Safety Officer in this program shall be Mark R Juarez RPb

15 Before radioactiv( materials may be used at a temporary job site at any federal facility the jurisdictional status of the job site must b ~ detenninel If the jurisdictional status is unknown the federal agency should be contacted to determine if the jtlb site is under exclusive federal jurisdiction A response shall be obtained in writing or a record made of the nane and title of the person at the federal agency who provided the determ ination and the date that it was provided Auth )rization fOl use of radioactive materials at the job sites under exclusive federal jurisdiction shall be obtained either by

(a) Filing an NRC Form-241 in accordance with the Code of Federal Regulations Title 10 Part J5020 (b) Recognition of Agreement State Licenses or

(b) By applyir g Or a specific NRC license

(c) Before radioactive material can be used at a tempOrary job site in another State authorization shall be obtained from the 5tne if it is an Agreement State or from the NRC for any non-Agreement State either by filing for reciprocit) 01 applying for a specific license

16 Sealed sources posessed under this license shall be tested for leakage andor contamination as required by Title 17 California Code 0 Regulations Section 30275 (c)

)7 In lieu of the IDak test intervals required by California Code of Regulations Title J7 Section 30275 (c) sealed sources can be t~led for leltJkage andor contamination at longer intervals when tbey are specified in a certificate of registration issumiddotd by the US Nuclear Regulatory Commission an Agreement State or a Licensing State When a longer interval s ipulated in a certificate of registration is used the certificate must be maintained on file and available for inspection fo as long as he associated leak test records are retained

8 Quantitative am 1)Iical assays for the purpose of tests for leakage andor contamination of sealed sources shall be performed only) persons Decifically authorized to perform that service

19 The following individuals ate authorized to collect wipe test samples of sealed sources possessed under this license using leak test k ts acceptable to the California Department of Public Health

(a) The Radialicn Safety Officer (b) Qualified individuals designated in writing by the Radiation Safety Officer

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 23: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

09262011 1318 FAX 9164407999 RWlULUlaC HfjALTIi ISKAltt-U lI6lUVUl VVI

State of California-Heat lI nd Human Serv Agency california Department of Public Health

Page 5 of 6 pages

RADIOACTIVE MATERIAL LJCENSE license Number 7131-43

Amendment Numoor 12

20 The licensee ShIll conduct a physical inventol) every six months to account for all sealed sources andor devices received and pomissed und(~ the license Records of the inventories shall be maintained for inspection and may be disposed of follOlIing Department inspection

2 J Where users or th ir assistants are engaged in elution of from generators the exposure to the fingers or hands shall be monitored as required by T tie 10 Code of Federal Regulations Part 20 Section 201502 (8)

22 The licensee shlIl comply Nith all requirements of Title 17 California Code of Regulations Section 30373 when transporting or dcdivering radioactive materials to a carrier for shipment These requirements include packaging marking labeli IF loading storage placarding monitoring and accident reporting Shipping papers shall be maintained for inIJection pursuant to the US Department of Transportation requirements (Title 49 Code of Federal Regulations Pat J72 Sections 172200 through 172204)

23 Radiopharmacellt r~ls may be redistributed to persons licensed pursuant to Title 17 California Code of Regulations Section 30195 a and (b) middot)r a specific license issued by the US Nuclear Regulatory Commission an Agreement State or a Licer sing State in accordance with the statements procedures and representations in Condition 13 of this license

24 The licensee is hereby granted authorization to retrieve radioactive waste from customers facilities in accordance with the procedures (iecribed in ondition 13 ofthis license Collection of radioactive waste from customer facilities shall be limited to W85tlt generated from materials supplied under conditions of this license

25 Equipment for miiometric assay of pharmaceuticals body fluids excreta or in vitro assay samples shall be calibrated to enmre the reliubility of data obtained The stability of the equipment shall be checked at least once on each day of use uing appropriate standards

26 The licensee is a Jthorized to hold radioactive materials with a physical half-life of less than 90 days for decay in storage before disposal in ordinary trash provided

(8) Radioactbe waste to be disposed of in this manner shall be held for decay in storage for at least 10 half-lives

(b) Before di5p)sal as normal waste radioactive waste shall be surveyed to determine that its radioactivity cannot be distingllinned from background All radiation labels shall be removed or obliterated

(c) Records 5111111 be maintained of the disposal of licenied materials made by decay in storage These records shall be sufficknt to demonstrate compliance with this license condition and shall be retained for 3 years after the record is nll de

(d) Generator clumnsshall be segregated so that they may be monitored separately to ensure decay to background levels prier tJ disposal

27 In addition to de oossessiol1 limits in Item 8 the licensee shall further restrict the possession of licensed material so that at no time vi the total quantity of radioactive material possessed require financial surety for decommissioning in accordance witt the California Code of Regulations Title 17 Section 301951 A value of 100 microcuries IS

assigned to Cobalt-57 to sUjplement the Code of Federal Regulations Title )0 Part 30 Appendix B

28 The licensee shall comply with the requirements described in the RHB document entitled Increased Controls (1C) for Licensees tbat Possess Sources Containing Radioactive Material Quantities of Concern The IC requirements shall be implemented bfore taking possession of any IC quantities Upon completion of implementation the licensee shaH notifY the Radi(logic Health Branch (RHB) of the California Department of Public Health (CDPH) by telephone and in writing Writel notification is to be sent to

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 24: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

tJlllVVlt VU

State of California-Hea tl and Humar Serv Agency California Department of Public Health

Page 6 of 6 pages

RADIOACTIVE MATERIAL LICENSE License Number 713 1-4 ~

Amendment Number J2

CDPH Radiologic Health Branch Radioactive Material Liceming A TT Increased (ontrols Pr)gram MS 7610 PO Box 997414 Sacramento C (JS899-741~

Telephone notifiction shall be made to the local RHB Inspection Office Local RHB 1nspection Office telephone numbers are

Northern Califo Ilia (510) 620-3416 or (510) 620middot3419 Southem Califo 11ia (714) 257-2043 or (74)257-2031 Los Angeles COllrrty (213) 35 J-7897 or (213) 351-7387 San Diego Coutty (858) 694-3621 or (858) 694-3616

21 The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health and Safety Code sectin 1150001 (h) to the California Department of Public Health (CDPH) on an annual basis for both shipped and stoei LLRW Alternatively LLRW shipment information may be provided on a per shipment basis LLRW shipmen information and annual reports shall be mailed to

Attn LLRW Tracking Program California Department of Public Health Radiologic Health Branch MS 7610 PO Box 997414 Sacramento CA 95899-7414

22 The licensee shall tomply with the requirements described in the California Department of Public Health Radiologic Health Branch letter with Imclosure entitled Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks dated June 5 2008 and California order dated June 5 2008 signed by Gary Butner Acting Chief R~ d llogic He alth Branch The licensee shall complete implementation ofsaid requirements prior to the time that tadi~clgtve materials are possessed at or above the quantities of concern as specified in Table 1 Radiolluctides of Concern contained within the Order

23 A copy of this Iketlse and a OPY ofall records and documents pertaining to this license shall be maintained available for inspection at 59)0-8 Obala Way Gilroy CA

la Department of Public Health

Date September 1~_2_0_11______ By --~J~~--~----~--==------------------------------

I Radiologic Health Branch

MS 7610 PO Box 997414 Sacramento CA 95899-7414

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 25: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

~

~ Remove your new Pocket License Board of Pharmacy

1625 North Market Blvd Suite N-219~ from the receipt portion and keep Sacramento CA 95834 on your person 916 574-7900

~ 070710 CUTIHERE~ 07107 IU

shy

~D Board of Pharmacy

1625 North Market Blvd HERE IMP 0 R TAN T ~ Suite N-219

Sacramento CA 95834 1 Please include your license Number with any correspondence 916 574-7900 to this office

pound 2 Notify the Board of Pharmacy of any name or addressREGISTERED PHARMACIST change in writing

LICENSE ~O RPH 45604 EXPIRATION 083112

3 Report any loss immediately in writing to the Board

4SH~~1l~~N5~mlA~d carry the Pocket License with you ~ liCENSE NO EXPIRATION RECEIPT NO

RECEIPT NO RPH 45604 083112 017000671-= amprfNCmiddot- t7 ltyen Please retain this receipt in a safe location01700067 ~ PPHRPH 1031107

PEASONAllNFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 26: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Alex Freed I BA Somerset NJ RAM License New Jersey BOP permit

Patrick Silo I BA Somerset NJ RAM License New Jersey BOP permit

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 27: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RADllO002 - 439619

New Jersey Department of Environmental Protection Bureau ofEnvironmental Radiation

Radioactive Materials Program Mail Code 25-01

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 et seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 439619 Issuance Date December 5 2011

License Number RADl10002 - 439619 Expiration Date October 312012

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pellicciarini 21000 ATLANTIC BLVD Radiation Safety Officer DULLES VA 20166 Melissa Achey RPh

PROGRAM INFORMATION Program Code Description

02500 Nuclear Pharmacies 02501 Cyclotron for Production ofRadio pharmaceuticals

LICENSE CONDITIONS This license is subject to the following conditions

Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~js licens~ tr~l bedfect~m~ateIY is issued on bebalf of the Department under the authority of SIgnature December 52011 Print Name Catherine JgtBie1 Date

Page 1

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 28: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RADI10002 ~ 4396]9

SECTION A - Materials Form Limits Uses amp Users

Material Form Max Limit Cobalt-57 Sealed Source 200 millicuries

Germanium- Sealed Source 200 millicuries 68

Iodine-I 3 I Any 990 millicuries

Rubidium-82 Liquid 3 curies

Any Sealed Source ) 0 millicuries byproduct material

permitted by i 10 CFR 3565 Strontium-85 Solid 6 curies

Strontium-82 Solid 3 curies

Any Sealed Source 10 millicuries byproduct material permitted by 10 CFR3565 Fluorine-IS Any 50 curies

Any Any 5 curies byproduct material with atomic number 1- 83 (TII2 lt120 days) Sodium-22 Sealed Source 5 millicuries

Any Any 2 curies byproduct material (Z == 3-83)

Authorized Uses Non-Human Use - Receipt storage use andlor distribution to authorized recipients ofsealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage use andlor distribution to authorized recipients of sealed sourcesdevices registered under 10 CFR 32210 which are intended for non-human uses only Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with lO CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with ] 0 CFR 3272 and for non-medical use Non-Human Use - Redistribution oheated sourcesdevices initially distributed pursuant to 10 CFR 3274 and to authorized recipients for non-medical use

Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Contained within a radiopharmaceutical generator device Non-Human Use - Calibration andlor quality assurance

Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use Non-Human Use - Receipt storage preparation andor distribution ofradioactive drugs and radiochemicals for medical use in accordance with 10 CFR 3272 and for non-medical use

Non-Human Use - Calibration andor quality assurance Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Authorized Users Melissa Achey RPh (ANP) William A Boerger RPh

bull(ANP) i Jeff Brannock RPh (ANP) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP)

i Patrick J SilIo RPh (ANP) Henry Wielgosz RPh (ANP)

I

Melissa Achey RPh (ANP) John Aymil (cyclotron operator) William A Boerger RPh (ANP) Jeff Brannock RPh (ANP) Sam Frackowiak (cyclotron operator) Alex Freed RPh (ANP) Arti Jinsi-Parimoo RPh (ANP) Beth Kraemer RPh (ANP) Jamie Perry RPh (ANP) Patrick J Sil 10 RPh (ANP) Henry Wielgosz RPh (ANP)

Page 2

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 29: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RADI10002 - 439619

SECTION B - Authorized Locations

Site Site Name Street Address Location Description ID

182101 IBA MOLECULAR 110 CLYDE RD SOMERSET NJ Stomge Possession Use cyclotron vaults manufacturing NORTH AMERICA rooms equipment rooms and packaging rooms

lINe Rad Material Radiation Release Point (Air Release) monitored releases of radioactive materials from exhaust stack

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (sienature)

Radioactive Material License NJ Full Application 91242002 Charles 1 Harless Application Radioactive Material License NRC Full Application 232003 Charles J Harless Application Radioactive Material License Renewal Certification ]01912007 Duann Vanderslice RPh Application Letter Amendment Request (Daily Dose Calibrator 412012009 Duann Vanderslice RPh

Check) Letter Amendment Request (Monitoring Devices) 41202009 Duann Vanderslice RPh Letter Amendment Request 51812009 David PeJlicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 30: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License -Amended License

Requirements Report

Subject Item PI 439619shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Sections B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of an Authorized Nuclear Pharmacist listed in this license document At least one authorized Nuclear Pharmacist listed on this ]jcense shall be physically present at the authorized location of use whenever licensed material is being used When an Authorized Nuclear Pharmacist is not present Cyclotron Operators listed in section A of this license document may only operate the cyclotron conduct researchdevelopment and testing productions [NJAC728-49(c)]

3 Licensed material shall be used by or under the supervision of individuals who have received the training described in documents including any enclosures specified in section C of this license document and have been designated in writing by the Radiation Safety Officer The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual [NlAC728-511]

4 CompJiance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

5 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CPR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (lOCPR3014through3021 inclusive) [NJAC728-511]

6 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the Jicensee except as specifically authorized [NJAC728-511]

7 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence ofa certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CPR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andor gamma-emitting material or not more than 10 microcuries of alpha-emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728-511]

Page I-I oflmiddot2

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 31: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

IBA MOLECULAR NORTH AMERICA INC 439619 RAD110002 RAD Materials License middotAmended License

Requirements Report

Subject Item PI 439619middot

8 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample lfthe test reveals the presence of 0005 microcurie (185 becquerels) or more of removable contamination a report shall be filed with the Department in accordance with NJAC 728-51] (10 CFR 3050(c)(2raquo and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (8) Tests for leakage andor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perform such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

9 The licensee shall conduct a physical inventory every six months to account for aU radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date of each inventory and shaH include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

10 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAC 728-511]

11 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (8) Removes or obliterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records of the disposal of licensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-511]

12 The licensee is authorized to transport licensed material in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC728-511]

13 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-supplied syringes and vials and their contents [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section C of this license document [NJAC728-511]

Page 1-2 of Jmiddot2

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 32: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO OERTIFY THAT THE

Board Df Pharmacy

liAS UCfNSED

fOR PRA~TICE IN NEW JERSEV AS AtN Phlnmlul1

~

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT TI-lE

Board of Pharmacy~ HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N Phartnlciat

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

_____ 28RI0341Z11m ____ LlCENS EftEGISTRATION~eFITI flCATION

-~-A-~--

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 33: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Arti Jinsi-Parimoo I BA Totowa NJ RAM License New Jersey BOP permit

Beth Kraemer IBA Totowa NJ RAM License New Jersey BOP permit

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 34: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RADI ]0003 - 452369

New Jersey Department of Environmental Protection Bureau of Environmental Radiation

Radioactive Materials Program Mail Code 25-0 I

PO Box 420 Trenton NJ 08625-0420 Phone (609) 984-5462

Fax (609) 633-2210

Radioactive Materials License

Pursuant to the Radiation Protection Act (NJSA 262D) and the Radiation Code (NJAC 728 el seq) as amended and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer radioactive material(s) designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations This license is subject to all applicable rules regulations and orders of the New Jersey Department of Environmental Protection now or hereafter in effect and to any conditions specified below

DOCUMENT INFORMATION Program Interest (PI) ID 452369 Issuance Date June 9 201]

License Number RADI10003 - 452369 Expiration Date March 312014

ADMINISTRATIVE INFORMATION Licensee Name and Administrative Address Administrator IBA MOLECULAR NORTH AMERlCA INC David Pelliciarini CHP 21000 ATLANTIC BOULEVARD Radiation Safety Officer DULLES VA 20166 Eric Schreiner

PROGRAM INFORMATION

Program Code Description 02501 Cyclotron for Production ofRadiophannaceuticals 02511 Medical Product Distribution - Prepared Radiophannaceuticals

LICENSE CONDITIONS

This license is subject to tbe following conditions Section A - Authorized Materials Form Limits Uses amp Users Section B - Authorized Locations Section C - Supporting Documents Section D - License Conditions

T~is license(~ch shall be e[~~i~~djateIY is issued on behalf of the Department under the authority of SIgnature ~ l _ June 9 2011

~

Print Name Catherine LIiie1 Date

Page 1

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 35: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RADII0003 - 452369

SECTION A - Materials Form Limits Uses amp Users

Material Cesium-13

Form Sealed Source

Max Limit 400 microcuries

I

Authorized Uses Non-Human Use - Calibration andlor quality assurance

Germanium-68 Sealed Source

1 millicurie

Sodium-22 Sealed Source

I millicurie

Any byproduct material with atomic number 3 - 83

Any 3500 millicuries Non-Human Use - Possession of incidentally activated byproducts arising from accelerator operation

Nitrogen-I 3 Any 3 curies

Any byproduct material Any 1 curie Non-Human Use - Receipt with atomic number 3 - 83 storage preparation andlor

distribution of radioactive drugs and radiochemicals for medical use in accordance with ) 0 CFR 3272 and for non-medical use Non-Human Use ~ Research and

Fluorine-18 Any 95 curies development instruction

SECTION B - Authorized Locations

Site Site Name Address ID

351221 IBA MOLECULAR NORTH 60 COMMERCE WAY AMERICA INC COMMERCE SUITE H CENTER Totowa Boro

Authorized Users Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti linsi-Parimoo RPh Hijin A Kim RPh Max Kiselev (cyclotron operator) Beth Kraemer RPh Due Lai (cyclotron operator) Serge Lyaschenko RPh Tim Neal (cyclotron operator) Norbert Owino (cyclotron operator) Jamie Perry RPh Eric Schreiner (cyclotron operator) Patrick 1 Sillo RPh Mark Soffing RPh Henry Wielgosz RPh Hussam Abbassi RPh Melissa Achey RPh William Boerger RPh Jeff Brannock RPh Frank Devine RPh Brian Host RPh Arti Jinsi-Parimoo RPh Hijin A Kim RPh Beth Kraemer RPh Serge Lyaschenko RPh Jamie Perry RPh Patrick J Sillo RPh Mark Soffing RPh Henry Wielgosz RPh

Location Description

Storage Possession Use - Areas of use at this facility include cyclotron vault manufacturing room equipment room and packaging areas Air Release - Monitored releases of radioactive materials from exhaust stack

Page 2

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 36: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RADI10003 - 452369

SECTION C - Supporting Documents

Doc Type TitlelDescription Date Contact Name (signature)

Radioactive Material License NRC License Application 11112002 Gregory S Hisel A-Wlication Letter NRC License Application 1202003 Gregory S Hisel Letter NRC License Application 9122005 Gregory S Hisel Radioactive Material License Renewal Application 352009 Anwer Rizvi AJPlication Letter Amendment Request 4202009 Duann Vanderslice RPh

i Letter Amendment Request 582009 David Pellicciarini CHP Letter Additional Application information 5292009 David Pellicciarini CHP Letter Amendment Reguest 322010 David Pellicciarini CHP Letter Addl Information 462010 David Pellicciarini CHP Letter Nuclear Pharmacy Status 982010 David Pellicciarini CHP

SECTION D - License Conditions (Requirements Report attached)

Page 3

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 37: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

1 This licensee must confine their use of radioactive materials to the materials physical forms maximum possession limits authorized uses and authorized users listed in Section A of this license document Licensed material shall only be used at the locations specified in Section B of this license document [NJAC728-511]

2 Licensed material shall only be used by or under the supervision of (A) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with NJAC 728-531 (10 CFR 3272(b)(2)(I) or (4) or (B) an Authorized Nuclear Pharmacist listed in this license document [NJAC728-511]

3 Compliance with State and Federal agencies having jurisdiction andlor regulations for radioactive materials andlor radiopharmaceuticals must be maintained [NJ AC 728-511]

4 This license does not authorize commercial distribution of licensed material to persons generally licensed pursuant to NJAC 728-521 (10 CFR 31) or to persons exempt from licensing pursuant to NJAC 728-511 (10 CFR 3014 through 3021) inclusive [NJAC 728-511]

5 Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee except as specifically authorized [NJAC728-511]

6 (A) Sealed sources shall be tested for leakage andlor contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State (B) Notwithstanding Paragraph A of this Condition sealed sources designed to primarily emit alpha particles shall be tested for leakage andlor contamination at intervals not to exceed 3 months (C) In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the US Nuclear Regulatory Commission under 10 CFR 32210 or by an Agreement State prior to the transfer a sealed source or detector cell received from another person shall not be put into use until tested (D) Sealed sources need not be tested if they contain only hydrogen-3 or they contain only a radioactive gas or the half-life of the isotope is 30 days or less or they contain not more than 100 microcuries of beta- andlor gamma~emitting material or not more than 10 microcuries of alpha~emitting material (E) Sealed sources need not be tested if they are in storage and are not being used However when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval they shall be tested before use or transfer No sealed source shall be stored for a period of more than 10 years without being tested for leakage andlor contamination [NJAC 728~511]

7 (A) Sealed source leak tests shall be capable of detecting the presence of 0005 microcurie (185 becquerels) of radioactive material on the test sample If the test reveals the presence orO005 microcurie (185 becquerels) or more of removable contamination a report shaH be filed with the Department in accordance with NJAC 728-511 (10 CFR 3050(c)(2)) and the source shall be removed immediately from service and decontaminated repaired or disposed of in accordance with Department regulations (B) Tests for leakage andlor contamination including leak test sample collection and analysis shall be performed by the licensee or by other persons specifically licensed by the Department the US Nuclear Regulatory Commission or an Agreement State to perfonn such services (C) Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years [NJAC 728-511]

Page 1middot1 of 1middot2

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 38: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

ISA MOLECULAR NORTH AMERICA INC 452369 RAD11 0003 RAD Materials License -Amended License

Requirements Report

Subject Item PI 452369shy

8 The licensee shall conduct a physical inventory every six months to account for all radioactive materials received and possessed under the license Records of inventories shall be maintained for five years from the date ofeach inventory and shall include the radionuclides quantities manufacturers name and model numbers and the date of the inventory [NJAC 728-511]

9 Except for maintaining labeling as required by NJAC 728-61 or 611 (10 CFR Part 20 or 71) the licensee shall obtain authorization from the Department before making any changes in the sealed source device or source-device combination that would alter the description or specifications as indicated in the respective Registration Certificates issued either by the Commission pursuant to 10 CFR 32210 or by an Agreement State [NJAc 728-511]

10 The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to ]20 days for decay-in-storage before disposal without regard to its radioactivity if the licensee (A) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding (B) Removes or obHterates all radiation labels except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee (C) Maintains records ofthe disposal of Hcensed materials for 3 years The record must include the date of the disposal the survey instrument used the background radiation level the radiation level measured at the surface of each waste container and the name of the individual who performed the disposal [NJAC728-5l1]

11 The licensee is authorized to transport licensed materia] in accordance with the provisions of NJAC 728-611 (10 CFR 71) Packaging and Transportation of Radioactive Materials [NJAC 728-511]

12 The licensee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to radiopharmacy-suppHed syringes and vials and their contents [NJAC 728-511]

13 In addition to the possession limits in Section A the licensee shaH further restrict the possession of licensed material to quantities below the minimum Hmit specified in NJAC 728-511 581 and 601(10 CFR 3035(d) 4036(b) and 702S(draquo for establishing financial assurance for decommissioning [NJAC728-511]

14 Except as specifically provided otherwise in this license the licensee shall conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures specified in Section D ofthis license document [NJAC 728-511]

Page 1middot2 of 1middot2

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 39: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS rOCERTIFY THAT THE

Board of Pharmacy

HAS LICENSED

IBA Molecular North America Inc Arti Jinsi-Parimoo 60H Commerce WayTotowa NJ 07512

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacy

_____28RS00706600 lICENSEREGISTRATIONCERTIFICATION

~ (~--

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

0312312011 TO 0413012013

~ ~~-~-- --Signa~ntcerttticaleHOldel

PERSONAL INFORMATION WAS REMOVED BY NRC NO COpy OF THIS INFORMATION WAS RETAINED BY THE NRC

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 40: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

State Of New Jersey New Jersey Office of the Attorney General

Division of Consumer Affairs

THIS IS TO CERTIFY THAT THE Board of Pharmacy

HAS LICENSED

FOR PRACTICE IN NEW JERSEY AS A(N) Pharmacist

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 41: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Darian Kirby I BA Texas RAM License Texas BOP permit

Julius Martin IBA Texas RAM License Texas BOP permit

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 42: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

1 t I IH I I

Depunmem of State Health Services

RADIOACTIVE MATERIAL LICENSE PUtUHll t th rt RlJIJuJn(mlnll ct mJ TtH DC[lnment (f Sure Ucahh Ser ie irt~f)o tCiUbtl(ln- 0 uJIldnn toJ tn rclune Ofl talemcru JIR rrprtntattom hefchltlfC muk h~ tJl~ Icnt J hent I h~rl1 ucd audKnzJnf the hc~ce tt retIc acqJlrc ro~t~ nd uamfer rahlJcthc Inlltrid Iilcd idow~ anJ [0 use ~uh rnlnCUH mllCMal flr 1he purpoI~j and1t tile rldCC(H di~lllcd heINl Tim IUemr o OhJert In all )rfhtlc rulti repulthon and rrdrT f fllt fItn~ fJO rr rertJhCT Ul dhr1 anJ Ii In cllnUuitm ~recifid beln

I -lame

~ Addrcs~

LICENSEE

IBA MOLECULAR NORTH AMERICA INC DBA fBA MOLECULAR ATTN JULIUS MARTIN III RPH 4447 BRASS WAY DALLAS TX 75236-2001

----------------------------------------~ RADIOACTIVE MATERIAL AUTHORIZED 5 Radioisotope

A Any mdioshyact ive material with a half-life lt 120 days and atomic number less than 84

B F-18

C C-li

D N-l3

E0-15

F Rb-82Sr-82

G 1-124

6 Form of Material

A Any except sealed sources

B Any

C Any

D Any

E Any

7 Maximum Acthmiddotily

A 3 curies

B 50 curies

c 5 curies

D 3 curies

E 3 curies

F FDA approved Rh- F 50 curies 82 generators

G Sodium iodide and G 5 curies laheled compounds

lt Tex timiniMnlive eml (TAO

Thil license is issued in response 10 a leiter

Dated October 10 2011

Signed b~middot David W Pellicciarini CHP VP

3 License Number IAmendmcI11 Number

L06174 II PREVIOUS AMENDMENTS ARE VOID

4 Expiration Date

October 31 2018 8 Authorized USC

A Receipt preparation and dispensing to authorized recipients

B Production and dispensing to authorized recipients

C Production and dispensing 10 authorized recipients

D Production and dispensing 10 authorized recipients

E Production and dispensing to authorized recipients

F Production of Rb-82 Redistribution of generators or dispensing of eluate to authorized recipients

G Production and transfer to authorized recipienls

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 43: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

ii~ I rn 1~1

ii U

DeplrImcm oj Siale Health SCfice5

RADIOACTIVE MATERIAL LICENSE ~1~J=E~=5=E~~=I~=IO~pound~R~---I-~O~-IE-~-T-~I-~8=ER~

L0674 11

5 RadioisolOpe 6 Form of Material 7 Maximum Activity R Authorized Use (conlinued) (continuedl tcontinueu laquocontinued

H Any H Sealed source H No single source to H Receipt and distribution 10 authorized Iildionuclide exceed 250 millicuries recipients with atomic (Total 350 millicuriesl numbers 3 through 83

I Any radio- I Activated I As produced I Storage only as activated components of the active material components cyclotron associated equipment andor building with Atomic associated equipment materials Number less andor building than 84 and a materials half-life lt 120 days

1 Cd-109 J Solid J 5 millicuries J Actiated components of cyclotron

K Co-56 K Solid K 3 millicuries K Activated components of cyclotron

L Co-57 L Solid L 3 millicuries L Activated components of cyclotron

M Na-22 M Solid M 3 millicunes M Activated components of cyclotron

N Na-22 N Activated N 25 millicuries N Storage only as activated components of a components cyclotron

O Cd-109 O Activated O 200 millicuries O Storage only as activated components of a components cyclotron

P Eu-J52 P Activated P 10 millicuries P Storage only as activated components of a components cyclotron

Q Eu-154 Q Activated Q 10 millicuries Q Storage only as activated components of a components cyclotron

R Activated R 200 millicuries R Storage only as activated components of a components cyclotron

R Mn-52m

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 44: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

iRf J rm 2gt1

5 Radioisotope (coninucu

S Mnmiddot52

T Co-56

U Co-57

V Cu-60

W2n-63

X Zn-65

Y Cu-6

Z V-47

AA V-48

BB Co-60

CC Co-64

DD Mn-54

6 Form of merial Icontinued

S Activated components

T Activated components

U Activated components

V Activated components

W Activated C(1mponents

X Activated components

Y ActiYated components

Z Activated components

AA Activated components

BB Activated components

CC Activated components

DD Activated components

7 Maximum Activity ContinuedI

S 200 millicuries

T 400 millicuries

U 100 millicuries

V 50 miJJjcuries

W 2500 millicuries

X 25 millicuries

Y 25 millicuries

Z 10 millicuries

AA 75 millicuries

BB 10 millicuries

CC 10 millicuries

DD 10 millicuries

L06174 11

8 Aulh(1rized Use (cominued

S Smrage only 35 activated components of a cyelonon

T Storage only as activated cnmponents of a

cyclotron

U Storage only as actiValed components of a cyclotron

V Storage only as activated components of a cyclotron

W Storage only as activated components of a cyclotron

X Storage only as activated components of a cyclotron

Y Storage only as activated components of a cyclotron

Z Storage only as activated components of a cyclotron

AA Storage only as activated components of a cyclotron

BB Storage only as activated components of a cyclotron

CC Storage only as activated components of a cyclotron

DD Storage only as activated components of a cyclotron

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 45: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Department of Slale Health Scniccs

RADIOACTIVE MATERIAL LICENSE ~17IC~E~~~S~E7~~1~IB~E~P--A~~F~~n~~E~~T~~I~~m~ER~~

L06174 11

5 Radiois01ope i continued I

EE Mn-56

6~ Fonn of ~lalerial I continued I

EE Activated components

7~ Ma~imum AClhily (continued I

EE 10 millicuries

8~ Amhorized Use (continued)

EE Storage nnly as activated components of a cyclotron

FF~ Na-24 FF ~ Activateu components

FF 10 millicuries FF Storage only as activated components of a cyclotron

GG 11pound1-27 GG Activated components

GG 10 millicuries GG Storage only as activated comptmems of a cyclotron

HH AI-28 HH Activated components

HH 10 millicuries HH Storage only as activated components of a cyclotron

II Ge-68Ga-68 II Sealed Source (Model BM06E Series Model BM06S)

II 05 millicuries II Calibration and reference source

9 Radioactive material shall be stored and used only at

Site Number 000

Location DalJas shy 4447 Brass Way

10 Each site shall maintain documents and records pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Site 000

II The licensee shall comply with the provisions (as amended) of Title 25 Texas Administrative Code (TAC) sect289201 sect289202 sect289203 sect289204 sect289205 sect2892S1 sect289252 sect289256 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operation of the cyclotron production of radioactive material dispensing of rndinpharmaceuticals

Jeffrey Kuehnhoff RPh

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 46: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Depanmem of Stale Hcallh Sen icclt

RADIOACTIVE MATERIAL LICENSE rUr~~~~~~~~

12 (coninuedl

B Operation of the cyclotron production of radioactive material

John Armbruster Edward Jacobs Jay Pfeiffer Ahmtld Baker Gary Kenny TimOlhy Pisarczyk Bonnie BenninglOn Max Kisele Erneslo Samuel Philippa Brisard Due Lai Eric Schreiner John Chadwick Davjd Lamont Thomas Seimer Sky Cui Matmew Looney Richard Shaw Otto S Garci Jr Many Magerl Tommy Sjarief 0110 S Garci Sr Manuel Melgoza Roben Symons Christen Garner Tim Neal Charles Talarico Roben Hallgren AI Parra Linwood Tucker Todd Heiskell Alba Perez Ken Voelker Victor Holguin Frery Perez Frank Vraniak Frank herson Bob Ylimaki

C Dispensing of radiopharmaceuticals

William Boerger RPh Darian Kirby Phann D Christopher Scott Olds RPh Jeff Brannock R Ph Serge Lyashchenko PhannD Jacob Dustin Summer PhllnnD Hayden Honeycun RPh julius M Manin III RPh Henry Wielgosz RPh

13 The individual designated to perform the functions ofRadiation Safety Officer (RSO) for activities covered by Ihis license is Julius Manin Ill RPh

14 A copy of the current operating and emergency procedures shall be kept at the cyclotron control panel The cyclotron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive changes in or additions 10 the licensees operating and emergency procedures shall be submitted 10 the Agency for approval before being incorporated into that document

16 Radioactive material authorized by Ihis license may be dispensed only to authorized recipients in accordance with the requirements of the United States Depanment of Transponation (DOT) United States Food and Drug Administration (FDA) the Texas Fond and Drug Division of the Texas Depanment of Healm and the Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in areas where active processing of radioactive material is conducted must be performed and documented ellch day Documentation of the surveys mllst he maintained for a period of two years for Agency review

)8 Raoiopharmaceuticals that are procured shall be from anorher licensed nuclear pharmacy or from an FDA approved supplier

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 47: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

IfU t(n I~ q

Department of Stale Health Scnice~

RADIOACTIVE MATERIAL LICENSE ~L~~~E~~~~E~N~I~m~E~R-r-~~If~~r~J~lE~~T~~I~~m~Ep~

L06174 11

19 The licensee shall maintain a record for Agency review of all radiopharmaceuticals dispensed The record shall include the radiopharmaceutical dosage procedure physicians name patients name physicians radioactive material license number the date and time radiopharmaceutical is dispensed and Ihe delivery method Records of distribution of other radioactive material shall also be kept which include the type quantities form cuslOmer name license number date and delivery method

20 The licensee shall use a calibrated dose calibrator to assay all single and multiple dose radiopharmaceuticals which are prepared and dispensed by the licensee and shall provide appropriate assay data with each dose dispensed However when the product is distributed in the unopened manufacturers container with the manufacturers original assay label auached additional assay by the licensee is nOI required Any additional prescription accompanying the product shall reference the amount dispensed by stating manufacturerS assaymiddot

21 The licensee may perform in house leak tests of sealed sources in their possession in accordance with the provisions of 25TAC sect289201(g)

22 The licensee shall conduct a physical inventory every six monlhs to account for all sealed sources received and possessed under the license The records of the inventories shall be maintained for inspection by the Agency for two years from the dated of the inventory and shall include Ihe quantities and Ihe kinds of radioactive material the name of the individual location of sealed sources and the date of the inventory

23 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under authority of this license in excess of 100 microcuries of betagamma-emitting material or 10 microcuries of alpha-emitting material

24 The licensee may receive sealed sources from client facilities for redistribution 10 authorizetJ recipients

25 The licensee is authorized 10 store radioactive material with a pbysical half-life of less than 120 days for decay-in-storage before being discarded as non-radioactive waste provided the radioactive material is

A Held for decay a minimum of 10 half-lives

B Monitored with an appropriate survey instrument to ensure radiation levels are not distinguishable from background and all radiation labels are removed or OIherwise obscured prior to being discarded as normal waste

26 The licensee shall report any irregularities 10 Ihe Agency associated wilh identification labeling quality or assay of any radiopharmaceutical received or dispensed under the authority of this license A written report shall be SUbmitted 10 the Manager Emergency Monitoring Group within 30 days of such an occurrence

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 48: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Il~ t ru 1 I Ilmiddot ~~

Departm~n1 uf Slate Health SerVIces

RADIOACTIVE MATERIAL LICENSE ~1~lr~fS~S~E~~l~M~8E=R-T~~IF~s~n~IE~middot~T~~~t~M~na~~

L06I74 J J

27 Except as specifically provided otherwise by this license the licensee shall possess and use [he radioactive material authorized by this license in accordance wilh statements representations and procedures contained in the following

application dateo February 252008 leiters daled August 182008 September 12 2008 October 27 2008 April 20 2009 and

May 112009

Tille 25 TAC sect289 shall prevail over statements comained in the above documents unless such statements are more restrictive than the regulations

JRSj5 FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Dale OClober 26 2011 J SCOIi Kee Program Coordinator

Medical and Academic Licensing Program

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 49: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

License No Expiration Date

38345 9302013

JULIUS M MARTIN Cert Name MARTIN JULIUS M

REGISTERED PHARMACIST

G Dodson RPh ~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

License No Expiration Date

50721 4302012

DARIAN THOMAS KIRBY Cert Name KIRBY DARIAN THOMAS

REGISTERED PHARMACIST

~ Executive DirectorSecretary

This Renewal Card Must Be Displayed With The Wall Certificate

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 50: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Jeff Kuehnhoff PETNet Texas RAM License Massachusetts BOP permit

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 51: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RECEIVED 08032810 0436 7037874079 lBA MOLECULAR

FrornIBA ~Iolecular Dallas 12143312450 08032010 0220 455 P006J012

RECEIVED 0514210 1138 9785217093 lEA HAVtF-HILl Pe tI~ET So lu li on~ PagelS

me Form l~middotl fage 1of5 OSJrn

Department of State Health Services

RADIOACTNE MATERIAL LICENSE PunllJllll~ d Tell3llllllliation COI1UOI Act and TIIM J)CparIIllCllI of StUt HtlIb SClVicel IA8cnCl1 ltguiJOOIlS 011 rsdilldonand InreliMe 11ft ~~clCII1Id rlt~tI~OIo llrelolore nude by hi UleIlset 31itcnse Is hlrcby lsMd lulllorltll1lll1W IIQ~ I) rcmYfbull quire ~1IIld O1Ill5fcr Indioaclivc IIIiIlerlilJ Itskld below ilIlIlgt urc SIlth ~I~t mlltml fOr W lUIlJOHill and allbt ~) dsigmlVG below This liccu is lIbjW1Il alllljllilabk ruIQ rcgullllolII and orlltn uribe A)IWy nuWIJT ntrftr Ifl effect and 10 3Y toodlllOn~ Deemed below

LICENSEE [IbIs license Is Issued in resporuc to a leiter

1 Name PETNET SOLUTIONS lNC Daled October 8 2009 ATTN ADRIAN ESTRADA 6911 ALAMO DOWNS PARKWAY SIgned by David 1 Krueger CHP SAN ANTONIO TX 78238 COlJ19rate RSO

J License Number IAmendment Number L05569 22

PREVlOUS AMENDMENTS ARE VOID 4 Expiration DIltt

--------------------------------------~ RADIOACTIVE MATERIAL AUtHORIZED August 31 2011 S Radioisolope 6 Form ot Malerial 7 Maximum Activity 8 Autbori1ed Use

A F-l8 A Any A 20 curies A Production and dispensing to authorized recipients

B Any radioshy B Sealed sources B No single source (0 B Use storage and redistribution of sealed active malerial and reference sources exceed 250 miUicuries sources and distribution of reterence sources with a half life Total 350 miUicurics tess lhan 120 days and AlOmic Number less than 84

C Any radio- C Activated C 2 curies C Production possession and storage active material components mcideJUal to operation of the cyclotron with a half life associated equipment less than 120 andor building days and materials Atomic Number Jess than 84

D C-ll D Any D 10 curies O Production and d~pcnsing to authorized recipients

E Cd-I09 E Ac[ivllted foils E 200 millicurles E Production possession lind ~toragc incidental to operation of the cyclotron

F Comiddot57 F Activated foils F 200 millicuries F Production possession and storage incidental to operation of the cyclotron

G Zn-65 G Activated G 50 millicuries G Production possession and storage COmpOIltllts incidental 10 operation of the cyclotron

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 52: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RECEIVED 08032010 0436 7037874879 IBA MOLECULAR

FromIBA ~olecular Oaf las 12143312450 08032010 0221 455 P0071012

RECEIVED 851412010 11 3D 97952171383 lEA HAVERHILL NAY-14-201O 1029 From 2107671013 PelNET Solullon~ Page2middot5

TIle Futln 12middot OAl~

5 RadiQisotope (continued)

H Co-60

1 W-181

J Mn-54

K Cs-134

L Eu-152

M AIly

N N-I3

Department of SIIIIr ltenlth SCrviCd

RADIOACTIVE MATERIAL LICENSE

6 Fonn of Materiel (continued)

H Activated componentS

r Activated components

J Activaled components associated equipmentlmuerials andor building materials

K Activated componenls associated equipmentmaterials andor building materials

L Activated components associated equipmentmaterials andor building materials

M Sealed source

N Any

7 Mnximum Activity (conlinucd)

H 10 millicuries

I 100 millicuries

J 10 miUicuries

K 10 millicuries

L 1 millicurie

M No single source to exceed 7 mnUcuries Total 10 millicuries

N 2 curies

r-UCEff=oSEhUMmllEIt-r---AMEN~f)MpoundN=TNtIM7II=-=ER-

[05569 22

8 Authorized Use (conlinue()

H Production possession and storage incidental to operation of the cyclotron

1 Production possession and slorage incidental to operation of the cyclotron

J Production possession and storage incidental to operation of the cyclotron

K Production possession and storage incidental (0 operation of the cyclotron

L Production possession and storage incidental to operation of the cyclotron

M Calibration and reference sources

N Production and dispensing to lluthorled recioientq

9 Radioactive material sha1l be stored and used only ar

~ite Number Location 000 San Antonio - 69(1 AJamo Downs Parkway

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 53: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RECEIVED 08032010 0435 7037874B79 lEA MOLECULAR

From IBA Molecular Dallas 12143312450 080312010 02 21 455 P008012

RECEIVED 1l514i2eurol1O 1138 9785217083 BA HAVERHILL I1HY-14-20HllO30 rrom21t37671G13 PettET Solutions Pa~IO35

TRC F0111lIN 0lI()I

OeparoneOl or SlI(e Health Services

RADIOACTIVE MATERIAL LICENSE ro~lCllImiddotSIlUIWMlI=IiR-r--AIdE=N1IMIf1r~N~U~-lkEII

L05569 22

to Each si[e shall maintain documents and CIWros pertinent to the operations at that site Copies of all documents and records required by this license shall be maintained for Agency review at Sile 000

11 The licensee sball comply with the provisiont (as runended) of 1AC sect289201 sect289202 sect289203 sect289204 sect289Z05 sect289251 t sect2892S2 sect2892S6 and sect289257

12 Radioactive material may be used only by the individuals listed below for the uses specified

A Operntion of the cyclotron production of radioactive material dispensing of radiopharmaccuticals

Michael W Bush RPh Allen Fazekas RPh Jefftey Knehnhoff RPh Adrian Estrada RPh Diederik Fikkert R Ph Elliot Rosario RPh

D Operation and maintenance of the cyclotron prOiluctil1n of rauioactive 11llIlerial

Steven Neil Lane Carlos Lompour Gregory Weaver

C Operation of the cyclotron produLtion of radioactive material

Ruben Cisneros

D Dispensing of rndiopharmaceulicaJs

Ameenab Campbell R Pb

13 The individual designated to perform the fUnelion~ ofRadilltion Safety Officer (RSO) for activities covered by thls license is Adrhm E$lrluIa

14 A copy of the current operating and emergency pmcedures shall be kept at the cyclotron control panel The cyclolron shall be secured to prevent unauthorized use when not in operation

15 Proposed substantive chlUlges in or additions to the licensees operating and emergency proccdures shall be submitted to the Agency for approval before being incorporlled into that document

16 Radioactive material authorized by rhis licell5e may be dispensed only to authorized recipients in accordance with the requirements of the United States Department ofTransponation (DO) Unitcd States Food and Drug Administration (FDA)lhe Bureau ofFooo and Drug Safety oCthe Texas Department of Stale Health Services and Ibe Texas Board of Pharmacy (BOP)

17 Surveys for fixed and removable contamination in afea5 where active processing of radioactive material is conducted must be performed and documented each day Documentation of the surveys must be mainlllined for a period of two years for Agency review

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 54: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RECEIVED 09032010 043E 7037874079 IBA MOLECULAR FromIBA Molecular Dallas 12143312450 08032010 0221 455 P009012

RECEIVED 05142610 113a 97a5217083 IEA HAVERHILL IIA)-1j-20W 1030 Fr(m2107671013 Pet~ET Solvllons Pase4-S

Page 4 of5

Depllrlmcnt of Slalll Healdl Servic~

RADIOACTIVE MATERIAL LICENSE r--1J~IiN=liEIlIll-~BER--r~~tEN=D~EIIT=N-UMIIHR

L05569 22

18 Rlldiopharmaceuticals lhat arc procured shall be from another licensed nuclear pharmacy or from nn FDA approved supplier

19 The licensee shall maintain a record for Agency review of all radiophannaceuticals dispensed The record shall include tbe radiopharmaceutical dosage pJocedure physicians name patients name physicians radioactive tnatcriallicense number the date and time radiophnnnaceuucal is dispensed and tbe delivery method Records ofdi1ttibulion of other radiuactive material shall also be kept which include he type qUllIltitie runn customer name licellllc number date and delivery methOd

20 The licensee shall use 1I calibrdted dose calibrator to assay all single and multiple dose radiopltannaceuticals which arc prepared and dispensed by the licensee and shan provide appropriale assay data w1m each dose ctispeosed Howver when the product is distributed In the unopened manufacturers container with Ihe mnnufaclUters original assay label attached additional assay by the licensee is not required Any additional prescription accompanying the product shall reference thtl amount dispensed by Slating manufacturers assaymiddot bull

21 The licensee shall conduct a physical inventmy every silt months to account for all sealed sources received and possessed under the license The records ofhe inventories shall be maintained for inspection by the Agency for two y~ars from the date of the inventory and shall Include the quanlititll and the kinds of radioactive material me name of Ihe individual location of sealed sources And th clute ofthe inventory

22 The licensee shall maintain a current copy of the safety evaluation from The Registry of Radioactive Sealed Sources and Devices for each sealed source received under aulbority of this license in excess of 100 mil1ocuries of beta-gamma emitting material or 10 microcuries of alpha--emitting material

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 55: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

RECEIVED 08032010 0436 7037874079 rBA r~OLECULAR

FromIBA Molecular Dal las 12143312450 08032010 02 21 3455 POl0012

RECEIVED e5142010 1130 9165217983 IBA HAVEKHILL HAY-14-2B10 1031 Fom2187671013 PeU~Er Solutions pageSS

ntc form 1M 081)1

D~arlm~nt of State Heallh Services

RADIOACTIVE MATERIAL LICENSE r-U=CF=I1st=IlUM-n=I1lI-l--MIl1D-M--EltT=--SMIIl1ll=---0

105569 22

23 Except 35 5~ifically provided otherwise by this license [he licensee shall possess and use the IlIUi~lllctivl material authorized by this license in accordnnce with slntements representations and procedures cOnlained in the following

appl icatian dated May 17 2002 and letters daled July 25 2002 April 16 2003 February 8 200S December 20 2005 and February l5 2007

Title 25 TAC sect289 shall prevail over statements conltioed in the above documents unless such statements are more restrictive than the regulations

KEMlJan FOR THE DEPARTMENT OF STATE HEALTH SERVICES

Date October 13 2009 X Scott Kcc Progrun Coordinator

Medical and Academic Licensing Program

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 56: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

ddad~~

AASSACH USErrSCOMMONWEALTI

tlutI[J 11l11JBOAROOF RL TRATION OF

PHARMACY

Pharmacist

121312012

DEPARTMENT OF PUBLIC HEAlTH

BoARI)O=iReGISTRATlON OF PHARMACY bull

Nuclear Pharmacist

~~~33145 121312012 186735

LICENSE NO EXPIRATION OATE SERIAL NO

PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 57: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Kunal Patel IBA Ohio RAM License (misspelled)

Ohio ANP form and Preceptor Grids Ohio BOP permit

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 58: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Amendment Nol11 Page of OHIO DEPARTMENT OF HEALTH

LICENSE FOR RADIOACTIVE MATERIAL

Pursuant 10 Clmpler 3748 of the Ohio Revised Code ond in reliance on stalements ond representutJons made by lhe Hcensee a license is herehy iSSUlli authorizing the licensee named herein to receive acquire posse$ and lronsfer rodiollctlve material us designated below to use 5uch material for the purpose(s) and at the place(s) designated below to deliver or trunsfer such materinJ to persons authorized to receive it in accordance with the applications of Chapter 3748 of the Ohio Revised Code and all rules promulgated thereunder This license shall be deemed subject to all npplicuble rules regulations nnd orders of the Oblo Department of Health now or bereinafter In clTect lind to any conditions specified below

LICENSEE LICENSE NUMBER

3 02500 18 0001 I lBA Molecular North America Inc

EXPIRATION DATE

4 December I 2016 2 21000 Allantic Blvd Suite 730

FILE 110 NUMBERSterling Virginia 20166

5 5010824956

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL 8 MAXIMUM QUANTITY THATmiddot FORM LICENSEE MAY POSSESS AT ANY

ONETIME UNDER THIS LICENSE

A Any rndiOllctive material A Jgtrepacknged units for in vitro A 740 lmq (20 mCi) permitted by role 37011-46-11 diagnostic tesl orthe OhIo Adrnlnistrutln Code

B Any radioactive materml with B Any B 222 GBq (6 Cl) IItOmiC numbers 110 83 inclusive except other nuclides listed herein

Co Fluorine-IS C Elementullind or C 1850 GBq (SO Cil rodlophurmuceuticul form

D Carbon-II D Elemental and I or D 740 GBq (10 Ci) radiapilarmacllliticalJarm

E Oxygen-IS E Elementa and I or E 740 GBq (10 Ci) radiophannactlltical Joml

F Nitrogen-I3 F Elemental and I or F 740GBq(JOCI) radiopllamlaCtlllical Jonn

G lI)dine-l24 G Elemental andlor G 166 GBq (450 mel) radiopilarrnaceutical Jaml

H Any sealed source permitted by H Sealed sources H 74 GBq (200 mei) tolal no rule 37011-58-26 oflhe Ohio single source to exceed 740 MUq Adrninlstralhe Code (20 mCI)

I Technetium-99m I Sodium perlechnelute and I 740 GBq (200 ei) products labeled in accordance with manufacturers instructions

1 Molybdenum-99 J Molybdenum-99 I 1 740 GBq (200 CI) Tecbnetium-99m generators

K Strontium-82 Rubidium-1I2 K Any rorm Generotors and K 333 GDI (900 mCI) rndioisotopes derived to prepare radioactive drugs for medical USI

L Strontium-liS L Any L 777 GBII (21 Ci)

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 59: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Page 2 of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellD 50108214902

SUPPLEMENTARY SHEET Amendment No 18

6 RADIOACTIVE MATERIAL 7 CHEMICAL ANDOR PHYSICAL S MAXIMUM QUANTITY THAT FORM LICENSEE MAY POSSESS AT ANY

ONE TIME UNDER THIS LICENSE

M AcUvation Producll M Any radioactive materials M 111 GUq (30 Ci) produced by llctlvution of cyclotron fntilities nnd machine paris by the operation of thc particlc uccelerutor

N Uranium (depleted in llolopes N Metal for generator and N 200 kilograms Uranium-235) product shielding

9 Autborized Use

A Redistribution of prepacknged in vitro kits to genernJ and specilic licenses 01 permitted by rule 3701 1-46-42 of lhe Ohio Administrntlve Code provided the pncknging nnd Inbeling remain unehn1lged

B - G Preparation nnd diltrlbutionlredistrlbution or radioactive drugs to lIuthorized recipient

H Authorizallon for caUbration transmllSionand reference sources for in bouse use lind distrlbutionlretrievol tnlfrom licensed recipients that hnl been mUDufuctured lubeled pllcknged nnd distributed in uccordunce with a specific license issned pursuunt to rule 37011-4644 of the Ohio Administrative Code NRC or equindent Agreement Slate regulations

l-K For use in produdng Technetium-99m Pertecbnelute and redistribution of generators to lIuthorized redpients

For generators

L Generators will he obtained from a manufacturer licensed pursuant to rule 37011-46-43 of the Obio Administrative Code or equivalent NRC or ngrcement state regulations

2 Unuled generators will be redistributed llithout opening or altering the manuracturers pucknglng

101 redi~1ributjon or used generators

I The manufacturers packngiDg and labeling will Dot be uUered

2 TIle gcnerutor will not he distributed beyond the expirution date shown on the generator lubel

3 111e generator will be accompanied by the manufacturer supplied lennet or brochure that proo1des rlldiution safety instructions Cor handling and using the generator

L Bymiddotproduct (impurity) of Sr-821Rb-82 generutors

M Activation praducl~ us a result of cydolron operation

N Shielding

10 UClI1sed material may only be used at the licensees racilities locMed at

7650 First P1uce Suite Ai Building D Oukwood Village Ohio 44146

II The Radiation Safety Officer for this license is

David Askew RPh

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 60: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Page J of4OHIO DEPARTM ENT OF HEALTH

License Number 02500180001LICENSE FOR RADIOACTIVE MATERIALS

FilellD 50108214902 SUPPLEMENTARY SHEET

Amendment No 18

12 Materials mny only be used by or under the supervision or the helow listed indhidual(s) designated in writing

Allthorizd Userts)

A Armbruster John F LniDuc K SeimerThomas

B Bennington Bonnie G Lamont David L Voelker Ken

C Brisard PhUippa H Magerl Marty M Ylimaki Bob

D Hallgren Robert l Neill Tim

E Heiskell Todd 1 Samuel Ernesto

Authorized NYklcar Phannncistl~l

A Askew Thnid R Ph D Chwojdnk Lynn Pharm D G Patti Darren J Pharm 0

B Boerger William n Ph E Honeycutt Hayden nPh H Prnlschler Shannon RIh

C Drannock JelT R Ph E Palel Klmllf RPIl J Wlelgosz Henry RIh

1 Young Derick RPh

IJ Nucienr Pharmacists performing licensed netlvlties shall he licensed by nnd in good stnnding with (he State of Ohio

14 Deliveries of radioactive mnterial to a mobile unit may be made only when tbe licensed recipient hos no authorized individual physically present 10 receive the rndiooctive material delivery

J5 The Radlalion Safety Officer shall conduct an nnnual formal program audit Audit review record~ shall be maintained ror D period of three (3) years from Ihe dole of the record Dnd conIDln the date of tbe audit the name of the individual performing Ule lIudlt areas audited audit lindings corrective actions Dnd follow-up nctions

16 The licen~ee is authorized to retrieve receive and dispose of radioactive waste from its customers limited to rndiopbarmacy supplied syringes Dnd vlnls and (heir contents

17 Tbe licensee shall conduela pbysicallnventory Cery six (6) months to account for all sources andlor devices received Dnd possessed under the llcense Records of Inventories sholl be maintained for allenst three (3) yeors from the dote of ealb Inventory nnd sholl include the llunnlilies ond kinds of licensed material mnnufacturers name and model numbe15locntion of the sources andlor devices lind the dllte of the inventory

18 The licensee sball maintain records to demonstrate compliance with dose limits for individual members of the puhlic as delineated In rule 370II-38middot13E) of the Ohio Administrntive Code The licensee sholl maintain records for review by the Director for II period of tbree years

19 Notwilils(anding lhe possesslon limits in item 8 tbe licensee sholl Curther restrict the possession of licensed materials to tlunntities below the minimum limit specified in rale 3701140middot17 of the Ohio Administrative Code for estuhlL~hing decommls~ioning finaDcialassurnnee

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 61: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Page of4OHIO DEPARTMENT OF HEALTH License Number 02500180001

LICENSE FOR RADIOACTIVE MATERIALS FilellO 50108214902

SUPPLEMENTARY SHEET Amendment No 18

20 Except as specifically provided otherwise in Ihis license the licensee shull conducllts program in accordance wilh the statements representations Dnd procedures contained in tbe documents including nny enclosures listed below The Ohio Department of Healths statutes rules and orders sball govern unless statements representations and procedures in tbe licensees application and correspondence ure more reitrictive Ihnn tbe regulations

A Application dmed October 25 2011and letter dated November 16 2011

B Amendment 18 to license 025001800 renewed in its enJirety

For the Ohio Department of Health

~~-1ZIt1IDATE BY b ----cshy~bief~ Bureau of Hndtntion Protection on bebalf of the Director of Heallh

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 62: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

Ollio Dt-partmem of lIealth SLTE OF OIflO BlIrlt-l11 of RadlJtlon ProtcctlCll1

jfd) hmiddot77

TRAININ( EXPERIENCE 10 PJUTEPTOJ STATE1ENT

The Ohio Dcpartmcnt of Hwlth Burlttu of RadlllOn fwtcttol1 is requcs(mg hsckllIh of all mtilnm11lt r )fj

this statement for the PUff)gt of aUlhmiling an indi idual to Hlrk ith radlIC(lH Imleri)l Failure If) 11) Ilk an) informatino ma~ reltult 1I1 Milia or deJal of (uthoriLirg m iudl IctuallO Nl Illih radl()ldn mmll ial

Instructions Comillete all apphcllhlc lIem Lse snppknlC1I11n sheets hefe nCCCi~)I~ Retain one t(lp~ ml submit original ofthe document to the Ohio Dcpartmclt of I1lth 246 orrh Illgh Slrct Burcll of Radlllioll Protection 17 Floor 3 Bldg PO Be lilt Columbus Ohio 4~1l6iJ l~

PART I TRAINI~( AND EXP[RIE~C[

Describe tramtng and expcncnce 111 sufficient detail to match the trmlllllg and cXjgtcrkncl cnlena ill upphcabk regulations (Chapter 11 of til OlllO dlllmjstrnri~middot Code)

L Xam oflndiYlduuL Propos-d Iuthorilalloll and rpplicabk Training RqulfImcllls

____ ~_JLf~ -~~_______ _______~_____ 2 Physician Podinrist OClllt~t or Pharmacist Sink or T(rritory Wh~re Licemcd

_J b(rt~cIgtA_________________ 3 CERTIFICATION

Month and Year(ertif~d

Tll follo 109 docs I~ nltcd Illlx compk~lcd when uSing BOllfd CcrtlficalH)11 to m~1 Chnptf IX of thc OlIO Adll1l1llstrativc tminlllg and ~ience ~~IfIments __________

Description of Training r-- Location IClock i Dales ofTraiuing I I Hours

~~~8tio~ Physics and lnstr~I~t~~---~oC -~rle i~r~~ -tiFF 81261

Radiation Protection-middot---middot--middot---middot~--l-middotO~i~r1( Uiimd+-~-~--~ ~-I OJ 10gt OIII-02G1i

-----~---~----~-~-------------~- -------+-~-~--~-----~--~-- p i-nmiddottOogth-+l lJnVttelIlflMathemaltcs ertammg to lise and I

Measurement of Radio3ctivify l 0

-------------~----l---------___J___ Chl~listr~ of Radioactive ilhttgtrial for Th lt th 0 0 jtUiVH~~ 3 Medleal Lse i q coiII - (8)211

----+-1- --- ~-------Oth il 0 ~ 0-0 ~middot ~e i ~ 1

tr ~ou~aAO omiddotoO~~ I UrWU-l~ i)L i~ 111 - 8-lt(1 I ____________ ~______~_______j-----------__c ___ _____ _ _

125

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 63: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

APPENDIX (J

S~Rmiddot_~~~~E~~~~~~~~~~~________~______------bull---c~- --__ ____ lO(lltiOIl llate and (lock

Nal1l~ of Supcrvising Corresp()ldin~ M alerials Hours of

IndhiduII1 r-

y (0 72i shy

__ __________ Ji1XLI_ middoti~ j) $ h ~ pound

()~vH-j twbof 10

811 - 8211

Number of Name of Location lIud Datt and ClOCK CII$e1i SuperVisinl COHtSPOlldiuf Hours of

Individual Iiateriuh Eperience License Number

126

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 64: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

APPENDI (i

()~ret Area uf Study or ltlime or PrOlram md Nanl elf OqmizttiIHi Ihal Residrn(y Pro~rIm Location ~itb pprmeil the Irognlln and

orrtspondilll( MA1~rials applkahltmiddot Re~tJlfition 0( License Number 37tH 1~5Smiddot51

7 Radiation Saf~ty OffinI - On( Year fullmiddotTim- Vork EXllclienrt (in arcllS idtlltifitd in number SHand 5b]

Compk~d Olle year offullllm radlallon saleh cxperience j In all areas J(jcnoflcd 10 number ill Hnde1 til

8 M~iclli Pbsidst - Olle Year Full-Time Trl1inincWQrk F~~ritllct

Yes A C()mphtcd mH vcar offull-timlt uaulJlg III tll~131MHiC radiological ph) SIC (IOCFR ~ l Suhpan J)

ArA or medlen ph~sk (OAt n01 1-5-X-191 unda lhe supcnlsin )f

ftquircmllts 10) AUlhJrlzd h~l(ltll PhysIClsl

and

= ie5

r(iA under the supcn iSlHn of

medlc(li physi(isl jr)(FR ~5 (161 Subpart J) or OHlis r(luinlTll1ts for Authori71d lykdwul Ph- silsb

(0( 3]OI1-lH91 (spC(if usr or dClce) __~_____

9 Supenistd Illdividual- ldenlification and QlIlIlificlItiuns

The [raillmg and Irhricnce indlcMcd ah() as ohlaind under the supCrviSWfl of (if morc Ih11 )n upn l~mpound

indlldualls ncxlcJ to mel f(x]uirfficrHlt It Chapltr R protd the j()ll(dng inf)nntlwn fbr L~ch)

Name If Supmiddotf bm SIIPrv is()f 1$

ulhcmzd usr u Iuthotizcd Medical PIlSlCisl ~ (h vJ 0 cl~_K_~__~_c~~~1Iiol1 SaftfY Ofticcc iulhorizd~~II-~lJ PtI1CtSI _

SUpc(l~vr meet fqllircmclts ofChaptcri8 or to (FR Plrt 35 Scctt()n(~)

for medical IISlt 1f1 Chapter 5)0 or 10 CFR ParI 5 StClion(s) ___~__~__~ _~_ _____ _

Malnals License Number (lndKltc hich SliJI (1f ifRC

C 2~QO ~QOO

127

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 65: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

PART II PRECEPTOR STATEMENT

OTE T1m part must PC cHmpktICG b the individual 0pr~Nptor f more than 01]( PJ(ltPIDI mcc~sn

10 document ~pCncll(i obtam a scparatl pM~pror statm~nr from arh llliS pJrIS nOi

to l1Icl th~ trallllll~ rlulrmcnl 111 0( n(i i 1-~-4

Cumbr HI lxkl n1ll~t Ix compllld for lIk~lr Ph~mnacl~h mc]Hg (h r(qllH~l1l~nts 01 Ii eFR Subpar JPrccp(fS di) Il() h1 10 c(lmpktc Itm~ 111 lb or the crtif~in~ ~lakl11lw fr olll indn iduals mccling th f0qulfCnl(iHS oj 1t) (FR Part~ Subpan J

)( tts HI The HHln ldual nam-d III lumber I has KHlsfa[onh cnmpkhd Ihc [rlIl1m rqllllltH1cnh P1 11

~A CFR Part 3~ 9)iO Subpml Jand is c(mp~t~nt to Jr1cipcll(kmh Opr~k a l1uclJf pharmac

Yes

li(~A (FR I)lft J SlctlOn(lt) and Pamgmphfs) _______________Ilr Chlpkr ~x (ilh

OhIO AdmllllstratlVe Lodt S(1Ion(s) and Paragraphi

IIh The lNiI vidual named in man)1 I l~ compd(1lt to iIHhptl1dclltiy fUllCIIOll as an ~U1tll(nld

for Chapkrj OiliomiddotdmmWltlC (ldc

12 Preceptor ApprOlallind Certification

~ ~rtif~ the appnhll of numbr Jn and certify I am all AuihUflLd ]udc)J Pillrm1cl~t

or 1 I ~11if the approHt of Ilumbel j la and lib and CC1ti~ t1l1t I run all AulhOrlzed udta Phanll)cm

or

(J I ixrtif t11 approal of Illrubl II a md J1b and crt f thu mcc) [he ODIl ((Xlm(lmrms of

____ seclKn(s) Chaplf i~ Admmlsratm Code or cqunaknl Agrlmcnl $JIlt rqlIf~mClli tel Ix

pnxcptor

[J Authorilcd User Radtaliou Saloty OiliC(1

For 111e 10110 109 uses of radiooctne matcri11(s under (hapte 51

Address )f Preceptor - b C 0 t= ~ gt~ T o-~e~-(~~~---~--~---

lt ftQrJ I 0 H i-J I-f 1-1

Mmnals License Numbtf (InhclIc which slate or ifNRC) 0) ~ C 0 8000 i _~ Lt L~f l(j2JJ) 4 fL ________ ------~-----------------

Print N me (~ PlccqllOr

idgtjt22 fl f 1j[)(pound(1 I~ f SlgnatujlPreccptor J Dat Snd 7

v

128

------

----------

----- ------

Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 66: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

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Training record to support ANP on site in Cleveland Ohio

OHIO RAM 2500180001 IBA Molecular Cleveland 7650 First Place Building B Suite A Oakwood Village OH 44146

Patel

FIGURE G-1 - Ohio NMS-LIC-13 Appendix G

AUTHORIZED NUCLEAR PHARMACIST TRAINING IN BASIC RADIOISOTOPE

HANDLING TECHNIQUES

Kunal M

IBA Molecular North America Corporate Headquarters 21000 Atlantic Blvd Suite 7 Dulles VA 20166 Phone (703) 787-7900 Fax (571) 434-0330

Title 9~~~cent~weinmiddotmiddot~I091lt1-lt - ILocation of ~ates ~otal -

Training IR n 2~~urn 125 RPP u_nn 122 BH Ohio State August Nuclear 59

University 12011 Pharmacy Columbus OH 1 through Certificate

August Program 26 2011

-

TOTALS ______ L _

Signature of Preceptor Authorized Nuclear Pharmacist I ccnify Ihat the above described trainingexperience has been satistactorily completed and that the individual has achieved a level of competency sutTicient to independently operate a nuclear

RPP - Radiation Protection Principles BI I - Biological Hazards

I Signature (- --1 ------------~--------

Print (tC(J7)At

IR Ionizing Radiation Units amp Characteristics INST - Radiation Detectiollinstrumentation

REG NRC Regulations and Standards

INST REG 88 20

Date I 111 1 -r111t(C-C I I

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 67: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

-----

-----

-------

--------

-----

------ -

record to support ANP on site FIGURE G-2 Ohio NMS-LIC-13 Appendix G IBA Molecular North America in Cleveland Ohio Corporate Headquarters OHIO RAM 2500180001 AUTHORIZED NUCLEAR PHARMACIST 2100 Atlantic Blvd Suite 7 IBA Molecular Cleveland Dulles VA 20166 I

7650 First Place Building B Suite A EXPERIENCE IN HANDLING RADIOISOTOPE Phone (703) 787-7900 Oakwood Village OH 44146 Fax (571) 434-0330

(Actual use of radlolsotopesunder t le supervision of an Authorized User or Radiation Safety Officer respectively) L-_________~

_I~lleI~~~~~ Firstbull Initial) Patel Kunal M e(s) Used Maximum amount used at

anyone time Locati on of Use Puroose oflJse Total Hours of

IBA Molel cular 1234567 460 Cleveland

15 Curies The Ohio State 1234567 40 Tc-99m 10 Curies Universit) 1234567 l~~99

--- shy

1

1 131 200 mCi 123456 1 shyi 1-123 1 mCi I Ga-67 -- 25 mCi

10 mCi _shy75 mCi

Sr-89 5mCi ffl~~fO~1___

-~--

123456~~j~15~3~~ ____

- -shy

----l----=-------j 123456 i Cs-137 125L________L__~_____J

ISignature of Preceptor Authorized Nuclear Pharmacist I I certify that the above described trainingexperience has been satisfactorily completed and that the I individml~has achieved a level of competency suf1icient 10 independently operate a nuclea~pha_rm_a_c_middoty__LI_)r_in_t_~~_________--__

Purpose of Use 1 Shipping receiving and performing related radiation surveys 2 Using and performing checks for proper operation of dose calibrators survey meters and other instruments used 10 measure photon-and

high energy beta- emitting radionuclides - and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides 4 Cakulating assaying and salely preparing dosages for patients or human research subjecls 5 Use of administrative controls to avoid mistakes in the administration of byproduct material 6 Use procedures to prevent or minimize contaminationor use of proper decontamination procedures 7 Compounding radiopharmaceuticais fl) distribution to authorized recipients

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 68: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name Kunal Patel Date August 262011

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist

RADIONUCLIDE RADIOACTIVITY USE EXPERIENCE LOCATION see below Actual clock hours

(Include date range of experience)

Mo-99 15 Curies 1234567 811 II The Ohio State UniversityTc-99m 10 Curies 1234567 through Medical Center 1-131 200 mCi 123456 812611 I Columbus OR

1-123 1 mCi 123456 Ga-67 25 mCi 12345 TI-201 10 mCi 12345 In-Ill 75 mCi ] 234

Sr-89 5 mCi 123456 8m-153 100 mCi 123456 F-18 200 mCi 123456

TOTAL HOURSCs-l37 02mCi 125 40 hours

Key for Use the number or numbers entered under Use should correspond to the handling experience for each radionuclide

1 Ordering shipping receiving radioactive materials and performing related radiation surveys 2 Calibrating using and performing checks for proper operation of dose calibrators scintiHation detectors

survey meters and if applicable instruments used to measure alpha- or beta-emitting radionuclides 3 Calculating assaying and safely preparing dosages for patients or human research subjects 4 Using appropriate internal controls to avoid mistakes in the labeling andor administration of by product

material 5 Using procedures to prevent or minimize contamination and using proper decontamination procedures 6 Learning emergency procedures to handle and contain spilled materials safely including related

decontamination procedures surveys and wipe tests 7 Eluting Tc99m from generator systems assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive d gs

Authorized Nuclear Pharmacist +~~-p-I~~pa~yenr Date August 262011

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 69: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

THE OIDO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name Kunal Patel

BRRMltD(DWN OF COURSE~CON1lliNTJNCL(C~lIlQURs Location of I Dates of Attendance I Course Total

Training Title Clock Radiation Radiation Math Radiation Radiopharmaceutical

Hours Physics amp Protection Pertaining to Biology Chemistryof

Instrumentation RadioactivityCourse

August 12011 Nuclear I 214 88 45 20 22 39 through Pharmacy

Certificate August 26 20 II Program

Note Show a breakdown of hours and subjects List each hour only once

under the most applicable subject category) TOTAL HOURS 214 88 45 22 39

~~~~~ Authorized Nuclear PharmacistAuthorized User DATE August 26 2011

George H Hinkle RPhMSBCNP FASHPFAPhA

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 70: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

The Ohio State University T bull H bull E

College of Pharmacy OHIO and SfA1E

UNIVERSITY

University Medical Center UNIVERSITY Department of Pharmacy MEDICAL

CENTER By this certificate warrants that

Kunal Patel has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 26 2011

~ iPw J ~ ) Directel Nuclear Pharmacy Dean College ~acy Associate Professor of Pharmacy

~7~- ~cJ~ Director Professional Experiential Programs Chair harmacy Practice College of Pharmacy ij College of Pharmacy

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 71: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

OHIO STATE BOARD OF PHARMACY 77 s High Btl Room 1702 Columbus OH 43215-6126

Phone 6 41466-4143 Fax 6141752-4836 website ~p~ohiogov

019793 Pharmacist

Identification Number RPH 03331490 Be it bo_ thal the iDdividual named 1Ie1ow J entitied to practiee in the State of Ohio Imtil the uplratlon date of SEPTEMBER 111 2011

PHA-04Q2(6110) Completion of1his form i required byOAC Rule 4729-5-02

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader

Page 72: IBA Molecular North America, Inc., License Amendment ... · Texas BOP permit enclosed. Jeff Kuehnhoff PETNet Texas listed ANP. Copy enclosed. Massachusetts BOP permit enclosed. Kunal

ThIs Is to rknredge the receIpt of YOUPPltcattoo dated J jj )0 ici and to inform you that the initial processing which

includes an administrative review has been performed

Itl Th~~4~~strate ~sfin~~ra~~ti~PwfJ2s~2 to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number middot5 7710 3 When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Since-rely (6-96) Licensing Assistance Team Leader