law review1

7/27/2019 Law Review1

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Pharmacy Law Review

Practice of PharmacyEducation Law: Articl e 137: 6801

Th e practice of th e p rofession of pharmacyis defined as th e administering, preparing,compounding, preserving, or thedispensing of drugs, medicines an dtherapeutic devices on the basis ofprescriptions or other legal authority, an dco llaborative drug therapy management inaccordance with th e provisions of sectionsixty-eight hundred one-a of this article.

PharmacyEducation Law: Article 137: 6802

Any place, other than a registered sto re, inwhich drugs, prescriptions or poisons arepossessed for th e pu rpose of compounding,preserving, dispensing or retailing, o r in

which drugs, prescriptions or poisons arecompo un d ed, preserved, dispensed orretailed, or in which such drugs,prescriptions or poisons ar e by advertisingor otherwi se offered for sale at retail.

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Note

The authors ofthis material prepared thisinformation to pr ov id e accurate informationregarding NYS pharmacy law effective t he date ofthis pr esentat io n . Th e authors stronglyrecommend th e user refers to the original lawsources from where th i s informati on was tak ena nd use the following presentation as an adjunctto th ose materials. The presentation is only asummary an d does no t intend to cov er the entiresco pe of NYS pharma cy law .

AdministerEducation Law : Article 137 : 6802

"Ad minister", for the purpose of se ction sixty-eigh t hundr

patient specific ordu or o n p o ~ t i e . n rspecific rt:&imen prescribed or ordered by aphy sici couuey i nwhich t h~ imm u niut io n is .:utmil'l ist tri. fo r immuniutlons 10 prtovtnl innuenuor n e u m O < : o ~ : a ld i s t ~nd medications quii'Hi for t merctncy ln-.umtnl of; ~o~ p h y l a x i s ;l h h ~cou ncy- w ~r r thr im m unit.llhOil 10 be- .Miminist t rt d hu p o p u l . : ~ t io n of sevt nryfi Vt thou sa nd Ofltss . thrn tht lictn)'cd physician or ce rtifiednurse p rctitiontr may bt in ; ~n adjomi ng councy. Such d m i n m : r ; ~ t i o nshll ~l im i t ~to immun iz.ing &tnts o prtvtnt inftut n:u o r pnturnoa.c-al i s ~ . I I . H.11ndm e d i ~ ( i o ns requi r ed for t muge ncy t rratmtnl of .l.naphyluis_ o r

.11 pouitnt specific o rder plts cribed or o r de r ~by ph ysicia n or ~ n i t i r dnuT$rp r . ~ c h t M t n ~ rfor immut\iutions to p V ~ n t c ut ~ hcrpu zoster.

DEFINITIONS


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Definition of a Drug

Articles recognized in; Th e official USP Official Homeopathic Pharmacopeia of the US Official National Formulary Or any supp lement to any of the above

Articles intended for use in the diagnosis,cure, mitigation, treatment or preventionof disease in man or other animals

Definition of Food

Articles used for food o r drink for ma n orother anima ls

Chewing gu m Articles use d for components of any s uch

article

Label

A disp lay of written, printed or pictorial matter upon th eimmed iate containe r of any dr u g, device or cosmetic. Anyrequireme nt made by or under authority of hi s articlethat any word, statement, or other information appear o nth e lab el shall no t be considered to be compiled withunless such word, stateme nt or other informati on alsoappears on th e outside container or wrapper, if here beany, of t he retail package of su c h drug , dev ice or cosmet icor is easily legible through th e outside container orwrapper.

Immediat e conta ine r does not includ e package liners.

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Definition of a Drug

Articles (o t h e r tha n food) i nt e nd ed toeffect the structure o r function of the bodyof ma n or other ani m als

Articles in tended for us e as a com pone n t ofarti cles in t he above clauses Not including devices

Cosmetic

Ar ticl es intended to be rubbed, poured,sp rinkl ed o r sprayed on, in t roduced in to o rotherwise appl ied to the human body forcleansin g, beautifying, promotingattractiveness, or altering the appearance.

Articles intended for use as a component ofan y such articles; except that the term shallno t include soap.

Labeli ng

All labels an d o ther written, printed, orpictorial matter

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GENERAL LAWS, RULES , AND REGULATIONS

REGUlATORY STRUCTURE AND

TERMS

Food, Drug and Cosmetic Act of

1938 Resulted f ro m 1937 sulfan il a mi de t ragedy

10 7 deaths caused by u se of di et h ylen e gyyco l(anti -freeze) in sulfan ilam id e e lixir

Incident propelled p assag e of th e 1938FD&CAc t

Dru gs mark eted prior to 19 38 we regr andf at hered

Du rham-Humphrey Amendment of

1951 Amen dment to th e FDCA Cr eated two catego ries of dru gs

Those t ha t required medical supervision :pres cripti on o r "leg e n d" drugs

Th o se that di d no t require medicalsupervis ion : "ove r- the-counter" orn onprescription drugs

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Pure Food and Drug Act

Signed in 1906 by Congress Proh ibi te d foods an d drugs that were

di st ribu ted through interstate co mmerce tobe adulterated or mi sbra nd ed Did no t require manufa cturers to li st

ingredien ts or directions Did no t regulate co smet ic p roducts or medical

devi ces

Food , Drug and Cosmetic Act of

1938 Any new dru gs m ust fi rs t be proven safe

w hen use d a ccor ding to the directions Requires labels includ e adequate di rectio ns

fo r use an d warn ing s abo ut habit fo rmingingredi en ts

App lies to cosme ti c products an d medicaldevices as well as food an d drugs

Durham-Humphrey Amendment of

1951 Required prescription drugs to include th e

lege nd on manufacturer 's label : "Caution: Federal law pr ohibit s d ispens in g

with out a pres cri pti on" {now "Rx o nl y")

Allowe d for oral prescriptions to bereduced to writing by th e pharmacist

Prescriber able to author ize refills


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Kefauver-Harris Amendment of1962

Resulted from thalidomide tra gedyof

1961

In th e US, was experimentally used in 1960FDA never gave final approval t o th e NDA.

Passed to ens ure greate r drug safety ANDeffective ness.

Medical Device Amendment of

1976 Class ification of devices according t o

sp ecific function Developed performance standards and pre

market approval requirements Manufac tu r er s must conform with GMP

st a n dards Mus t record an d report prop er information

Waxman -Hatch Amendment

Drug Price Competition an d Patent-T er mRestoration Act Made th e d ru g appr ov al pr ocess more effect ive

for generic drugs: must demonstr at e

"bioequivalence" to th e FDA Manufacturers of brand name products were

given specia l allowances as a resul t of goingthrough th e FDA appro va l pr o cess.

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Kefauver-Harris Amendment of

1962 Required a ll new dr ugs to be proven safe

AND effecti ve FDA is re spo ns ible fo r pr escr iption drug

advertising Require d i nf ormed conse nt fo r individuals

wh o were resea rch subj ects an d therepor ti ng of ADR's.

Creation of Good Ma nu facturing Pract ice(GM P)

Orphan Drug Act of 1983

Orphan drug Used to treat rare di seases

Tax an d licensing incentives tomanufac tu rers Made development of such drugs m ore

appealing (recover t he finances expended todevelop th e drug)

Prescript ion Drug Marketing Act of1987

Tighter re s t rictions o n the d ist r ibution ofpr esc ripti on samples an d products Ba nned th e sale, trade, or pu r chase of drug samp les Specifie d precise record-keepi ng requ irements fo r

drug samples (ie: storage ) Proh ibite d the resale of prescription drugs purchased

by hosp ita ls or health care facilit ies (the re were certainexceptions to this rule )

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FDA Modernization Act of 1997

On e major goal was to reenact th e 1992Prescr ip tion Drug Use r Fee Act (PDUFA) Major changes include:

Pediatric studies of drugs: manufacturers are given anadditiona l six months of marketing exclusivity if thedrug is accepted by th e FDA

States regulate pharmaceutical compounding an dpharmacies ar e exe mp t from GM P stan da r ds an d t heneed to submit new drug ap p licatio ns

Med icare Prescription Dru g Impr ovement,an d Modernization Act of 2003

The f ed e ral gove rnment con trols Medica r e Provide s seni ors and ind ividua ls with

disabilities with a pres cri ptio n drug benefit Part D

Prescri pt i on drug program Cos t to pati en t is in come -dependent

Medicare Part D

When a person enrolls , the premium and deductible are"foxed" from January 1 till December 31 of that calendar year.Co-Pays however may change if a d rug is moved to a differentcategory .

A pati ent may change plans only once yearly, between

October 15 through December 7, unless a special situationarises . Called Open Enrollment . Medi care Advantage Disenrollment Period: During this time

you can leave a Medicare Advantage plan and switch to anoriginal Medicar e plan . Runs from january 1 through February14.

s-Star Enrollment - A highly-rated insurance plan. Can switchonc e per year from December 8 - November 30.

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FDA Moderni zation Act of 1997

Expediting study an d ap p rova l of Fast trackdrugs used to treat serious or life -threateningconditions

Elimination o f certain label requir em e n ts "Caution: Federal law prohibits dispensing wit hou t

a p r e sc r i p t i o n' ~ "Rx onl y" "Warning- May be habi t forming " has been

e liminated

Medicare Part D

Patients w ho are no t in a low-incomeca tegory pay a mo nt hly premium an d mustmeet an annual deductible. After they meetth e deductible: Th e plan will pay 75% of he annual drug costs until

th e "coverage gap" is reac hed During th e "co verage gap" , patient pay s all drug costs Following the "coverage gap ", the plan resumes

coverage

Me d icare Part D

"Any willing provider"- requires all prescri p tionbenefit programs must partici pa t e with anyp harm acy ag reeing to the terms an d condit ion s ofthe plan.

Pa t ients will no t be required to ge t their drugsvia mail-order an d can receive greater than 30 -day supplies of ch ronic medications at a localpharmacy

Vaccinations a re no w covered under Part D(except influenza, pneum ococcal, an d hepatitis}


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Medicare Part D

Contains a provision for MTM (MedicationTherapy Management) Pharmacists are able to receive payment from

Medi care if the pa tien t is enrolled in Part D Every benefit program sponsor must develop MTM

pr og rams for patients enduring significa nt drug cos t sfrom a number of chron ic conditions

MTM in cludes: medicat ion reviews , an t icoagulati o nmanag ement, immunizations , etc.

Helpful Medicare website:h ttp: // www. med icare .gov/

Poison P revention Packaging Act -1970

Intent of protecting children un d er 5 yearsfrom acc ident al poisonings

En forced by Co nsumer Produ ct SafetyCommission

Requires use of child- re sista nt containersfor packaging most OTC's, prescripti ondrugs , an d hazardo us h ouse ho ld products Dispense on ly once in resistant container s or

vials

Medications Affected

Acetaminophen- package containing> 1 g Diphenhydra min e - con tainin g >66 mg Ibupr ofen - conta ining 2: 1g

Loperamide - conta inin g> 0.045 mg Mouthwash- conta inin g .2:3 g of et hanol Lidocaine - conta inin g> 5 mg D ibuca in e - containi ng > 0 .5 mg

Naproxen - containing 2: 250 mg

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Poison Prevention Packaging ActREGULATORY STRUC TURE AND

TERMS


Asp irin Methyl salicylate- liquid prod ucts

conta ining >5% by weight unless packagedin pressurized spray cont ainers

Contro ll ed substances Prescr ipti on drugs - or a l dosage forms I ron- all non-i n jectab le drug products an d

dietary supplements contain ing 2:_250 mg of

elementa l iron pe r package


Ketoprofen - containing 2:50 mg Fluoride - containing >50 mg of elemental

fluoride an d o.s % fluoride Minoxidil - containing >14 mg Nonprescription products - an y oral

product th at cont ains any active ingredientthat was previously available byprescription

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Child Res is tant Con t ainers

Des igne d to be sign ificantly hard forch ildre n


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Exceptions

Pancrelipase preparatio ns (tablet , capsule, pow der forms )

Prednisone tab lets: ~ 1 05 mg per pa c kage Methylprednisolone tablets: ~ 8 4mg per package Oral contraceptives: adm inist ered in manuf ac tur er 's

mnem onic dispenser Ho rmone replacement products- rely so le ly on the

activity of o ne o r more progest ogens or estrogens

Drug Approval Process

REGULATORY STRUCTURE AND

TERMS

In vestigational New DrugApplication

First application form a spo n so r mu stsubmit to th e FDA before administration tohuman s

Pr otects th e righ ts an d safety of hu m an testsubje cts Inclu de proo f of preclinical te st in g on animals

FDA ha s 30 days to decide whether th einvestigational drug is suitable for t es ting

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Anti-Tampering Act of 1982

Requires tampe r evide nt packaging be u sedfor select OTC products a nd cosmetics

Product has an indi cator or barri er to en try If he seal is br oke n , so me visib le ev id en ce of

entry w ill be evi dent

Product label mu st state t ha t it is a tamper -ev id en t pa ck age an d how to know if thepac kage h as been ta mpered wi t h

New Drug

Drug n ot recog niz ed among expert s as sa fean d effec t ive for use under th e conditi on srecomm e nded in the drug's lab elin g

Cl inical Trials - Phase I

Sma ll gr ou p of hea lthy patients Ultimate goal is to eva luate toxicological,

pha rm acological a nd pharmacok ineticdata , as well as assess safety i n hu ma ns

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Clinical Trials- Phase II

Larger group of patients ( ~ 1 0 0 )that havethe disease or sy mptoms

Primarily con ce rned with determininguse fuln ess in prevent in g or treating th edisease

Treatment Investigational NewDrugs

Allows th e administration of anin vestigatio nal new drug in those patientsw ho ar e no t enro lled in th e drug 's clini ca ltrial Pa ti en ts ar e at a life -threatening stage of heir

illness to w hi ch th ere is pres e ntly no cur e ordrugs ap pro ved to treat th e condition have no tbeen effect ive

Clinical Trials - Phase IV

Occ urs after drug pr o duct is mark eted Obta in additiona l data of drug's safety and

effec tiveness

Determine new uses or abuses

Hea lth care profession als ar e encoura ge d torepo rt any probl em s ex per ienced with th edrug 's u se (adverse ef fects)

FDA can withdraw drug based on datacollected

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Clinical Tria ls- Phase Ill

Large group of patients, u sually in a clini calse t ti n g

Provide s additional evidence of theeffectiveness and more information onadverse reactions

Provides additional information onoptimum dosing

New Drug Application

Requ est for appro val for marketi ng On ce ap proved, manufacturer may mark et

product

Co mp l e t e evaluation of sa fety an d efficacy FDA gene rall y rev iews NDA for at lea st 180

days and allows in t e rested indi vidual s toview an d comment on the app lication

Fast Track Approval

App rove d by th e Sec r et ary of HHS Allows for th e expedited approval of a

pot ential new drug if that product is: intended to treat a seriou s oflife threatening

conditi on AND addresses a n un m et m ed ica l ne ed

Approva l also conditioned on po st-mark et ing studies to ve r ify and describeth e drug 's benefit


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Abbreviated Ne w Drug Application

Requires less data than NDA but it doesrequire proof that th e new drug'spharmacokinetic properties, bioavailabilityan d clinical activity is similar to th eoriginal developer's product

FDA Classification fo r Ne w Drugs

Type P (priority) No other effective drugs available

Possess significant advantage compared tocurrently marketed drugs

Type S (standard) Similar to other drugs on th e market

Further Classification

TypeAA Drug with potential

use for AIDS or HIVrelated disease

Type E

Type F Drug that has been

placed on hold untilsubmitted data ha sbeen further validated

Drug for a life- Type Nthreatening or severely Drug being considereddebilitating disease for O TC status

Type V Drug being considered

for "orphan drug"status

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Supplemental Ne w Drug

Application Applies to manufacturers who originally

filed an NDA Utilized to adopt changes for an existing

drug product ranging from production tolabeling

Eliminates th e need to file a new NDA

Chemical Classification

Type1 New molecular

structure

Type 2 New derivative of a

molecular structurealready approved in US

Type 3 New formulation of a

drug already marketedin US

Type 4 New co m bination of

two or more drugs

Type 5 Drug is being

manufactured by a newcompany

Type 6 New therapeut ic

indication for a drugalready approved

CONSIDERATIONS FOR

MARKETED DRUG PRODUCTS

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Misbranding

Labeling is fal se or misleading Labeling is mis s ing either name or l oc at i on

of manuf ac t ur er / distributor

Label does no t co n tain a wo rd , state ment ,or other information required by lawdisp laye d in a prom in en t , rea d able manner

Label does no t include th e estab lishedna m e of t he active drug

Misbranding

Labe l has inadequat e direc tions fo r use fornonprescription drugs or does not include appropriatewa rni ngs req uir ed to protec t th ose using th e medicationo r pa ckaging

Label is n ot in accordance w ith USP/NF specifications Labe l offe rs the sale of th e dr ug und er th e nam e of

a nother drug Fai lure to pac kage d rug according to Poison Pr evention

Pac kag ing Act Does not po sses s t he state me n t, ''Wa rning-May be h abit

forming " on narc otic or hypnoti c substances

Manufacturer Drug Label

Na m e a nd ad d ress ofm a nu f actu re r packer distributor

Esta bli she d name of drug

Ne t quantity Weight of each ac t ive in gre dient cont ained

in ea ch dos ag e unit Federa l legend - "R x Only"

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Misbranding

Label do es no t have each active ingr edi en tidentified Labe l do es no t sta t e "Rx only" if a

pr esc ripti o n drug Labe l does no t contain a precautionary

st atement concern ing a d rug su bject todeteriorati on

Labe l is m iss in g quan tity of cont ain er'sco ntent

Product Labeling

The term "labe l" refers to wr itt en , printed,or gra phic matt er ap pearin g on th eimmediate con tain er of a drug produ ct If there is a n o ut side package , any word,

sta te m ent, or oth er inform at ion present on theinner containe r m u st also appea r on th eo ut side package

"Labelin g" refe rs t o th e ab ove, as well asan y a ccom panyin g wri tten, printed orgra ph ic matter (i.e. patient package insert)

Manufacturer Drug Label

If not t aken o raUy, th e s pecific ro ut e ofadministration

Speci al storage directions if ap plicabl e

Manufacturer 's contro l o r lo t number Expi ra tion date established by

manufacturer

State m en t dire ct ed to pharm ac is tspecify ing type of co nt ainer to be used indispensing

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Special Label Warnings

FD&C Yellow No.5( artrazine)

Aspartame Sulfite s Minera l oil Wintergreen Oil Sod ium Phosphates

Isoproterenolinha lation produ cts

Ipecac syrup Ph enac et in Salicylates (includin g

aspirin) Alcohol warning

Package Insert

Description (c hemical s tructur e, solubility,etc .)

Cl inical pharmacology Indicati ons, usage Warni ngs , pre ca utions an d

co ntraindications Adverse reactions

Patient Package Inserts

Regulation requ iring information t o beprovided to patient concerning amedi cation's Us e Potent ial Risks

Provided as a leaflet written in lay languag e Considered part of FDA-regulated product

labeling

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Package Insert

Manufacturer required to provide inprescription drug packages In f o rm at ion contained within insert must

be app rov ed by the FDA For informational purpo ses only

Package Insert

Drug abuse an d dependence Symptoms an d treatment of overdose Reco mmended dosage an d administration Available dosage forms Most recent labe l revi s ion date

Patient Package Inserts

Applies to all physicians , communitypharmacists, and hospita l pharmacists whod ispens e In acute car e ho spitals , regulation exempts the

provision of a PPI each time th e drug isdispensed

PPI must be provided prior to theadminis tr ation of th e first dose and every 30days thereafter


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Medication Guides

Manufacturers provide Medication Guidesfor certain prescription drugs that p ose aseri ous a nd signifi cant public hea lthco ncern Must obtain FDA a pp rova l of th e Me d Guide

an d supply sufficient copies to pharmacies

Applies to both new an d refill p rescr ipti ons

Pregnancy Warnings

Category A Have been adequ a te , well co ntrolled studies in

pregnant wo me n that de m onstrat e n o risk tothe fetus d urin g a ll tr im es ters o f pr e gnan cy

Ca teg ory B Adequat e, we ll co ntrolled st udi es have not

been conduct ed in pregn an t wom e n . An im a lrepro du ctive stud ie s h ave failed todemonstrate fetal risk.

Pregnancy Warnings

CategoryX Co n tr aind icat ed in pregnant women St u dies in an i m a ls o r reports in pr eg nant

wo m en , indicate that th e risk of d amage

ca used b y th e d rug clearly outweighs anyposs ibl e b en efit

5/22 /2013

Medication Guide s

FDA requires MedGuides when: Patient labe lin g co uld prevent serio us adve rse

effec t s The product has ser iou s risks rel ativ e to

benefits

Patient adherence to di rectio ns is c ru cial

Prescriber m ay req ue st a Me d Guide not beprovided to a part icula r patient

Pregnancy Warnings

Category C Safe ty of the drug durin g hu m an pregnancy

has no t bee n determined . Animal studies areei ther positive for feta l risk or ha ve no t beencondu cted.

Category D Pos iti ve ev ide nce of ri sk to hu m an fetus mainly

based up on adverse reaction data

Un it Dose Packaging and labeling

In fo rmati o n to be includ ed o n eac h unit-d ose package: Generic name and trad e name, if applicabl ( Q uantity of active drug

If mo r e than one , t he number of dosing units . Na m e an d place o fbus in ess o f manufacturer /pac ker /distributor

Lot o r co n trol number

Expiration date

'"Warni ng: May b e hab it form ing"' if app l icable , the properco n trolled substa n ce symbo l , in addition t o a n y r equir ed info .

O th er appropriate information if needed (ie : fo r a re cognized drug r ~f r i g e r a t e, "protect !Tom light, etc .

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Bar-Coding

FDA requires pharmaceutical companies toba r code all drug products supplied tohospitals (however hospitals are notrequired to utilize them) Prescription , biologicals , nonpres crip tion Single-unit containers used for unit-dosing Not physician samples

Bar code must contain product's NDC Considered to be part of produc t label

Subject to GMP

MedWatch Program

Enhances the effectiveness of postmarketing surveillance

Quickly identifies major he alth concerns Increase awareness of drug-and device -

induced disease

Clarify what shou ld be reported

Make it easier to report problems Pr o v id e regular feedback to the health ca re

community

Drug Recalls

Class I May ca use serious adverse health consequences,

including death Includes stock in pharmac ies and notification of

patients Class II

May cause temporary or reve rsib le effects Usually includes stocks in pharmacies

Class IIJ

Un like ly to cause any adverse he a lth cons equence

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REPORTING INITIATIVES

VAERS

Co -sponsored by CDC and FDA Vaccine Adverse Event Repor ting System

Surveillance system to report any eventconcerning th e ad mini stration of vaccineslicen se d fo r u se in th e US .

Compounding vs. Manufacturing

Due to the in creasing number of drugproducts compoun d ed by manufacturers,less compou ndin g is performed inpharmacies .

The main qu estio n is "When doesprescr iption compounding be co memanufacturing ?"

Refer to the FDA Compliance Policy Guideof 1992 to address this issue


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Compounding vs. Manufacturing

The quantity prep ared is rea so nable for filling eitherex isting presc ripti ons or anticipa ted o rder s based onp resc rib ing hab its of loca l prescr ibers.

Dosage forms comp ou nded a re not being prov ided or soldto ot her pharm aci es o r th ird parties.

Wha t is com pounded is no t cu rr entl y availabl e from am an ufactu rer/su pplie r

A pharm acy can say they specia li ze in prescriptioncomp oun d ing bu t CANNOT specify a specifi c prod uct

The ph armacy mu st lim it its in terstate distrib u tion ofco m pounded products to n ot more than s% of ts tota lprescr ip t ion vo lum e.

Repacking

Can be done by a pharm acis t, or anunlic ense d pe r so n un d e r the sup erv ision ofa regi st e red pharmac ist.

Labels o n repa cke d dr u gs shall bearsuffi cient in f o for p rope r ID an d safety .

Spec ific records mu s t b e ma in tained.

Recor ds must b e maint a in ed for 5 yearsan d mu s t be readi ly ava il able

NYS Organizati onal St ru ct ur e

REGULATORY STRUCTURE AN D

TERMS

5/22/2013

Expirations fo r Compounds

Always use stabili ty info rm atio n available If n o in format ion is avai lab le:

For no n aq ueous liquid s an d solids - no t moret han 25 % of he time remaining on th eco mm erci al produ ct or a max o f6 m on t hswh ich ever is le ss

Aq ueo us so lution s made fr om so lids - 14 dayswhe n store d at a co ld temp eratu re

Al l others : th e du ra t io n of thera py, n ot moreth a n 3o da ys

Repacking

Record keepin g in cl udes:N amto ~ n d st r encth o fthto dru gN.amto oftht' m oulu fact urto r a nd dist ribu tor (if diff f renl )Manuf act ure-r lot num b e r

Qua ntiry of each coma iMrNumbero fu nits ~ ~ r . d

Oa t t f t -t o~ c l d n E ~ C p i r a t i o nda tin gS ig na t u ~of p erso n p to rf o r mi n& th e re.pac king

Slaru.rure oft he ph


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State Education D e partmentEdu cation Law : Article 130 Subarticle 2: 6507

A dm in iste rs t he adm iss ion t o an d pra cticeof the p ro fessions Estab lish st a n da rds fo r pr e-pro fession a l

and p rof essi ona l e du cat i on , ex p erienc e a ndlice n sing examinati o n s

Reg is ter o r app rov e edu cat io n p ro gra ms Iss ue lice nses, reg istrat io ns, an d limit ed

permits to qualified appli can ts

State Board of Pharma cyEdu ca tio n Law: Arti cle 13 7: 6 804

Board co mp ose d of no t less t h a n 9 p h armaci sts licensed in th e

st at e fo r at least 5 ye a rs AN D

at lea st 2 pub lic re pr esen ta t ives

Exec u tive Sec re ta ry App oi n t ed by th e rege n ts on rec om m end ati on

of he co mm ission e r Licen se d in state for at least 5 yea rs

To PracticeEdu ca tion Law: Art icle 130 Subartic le 1: 65 02

A licen se is vali d durin g life o f the ho ld erun less revoked , an n u lled o r suspe n d ed byth e b oa r d of rege nt s

Must reg ister w it h e d ucat i on departm entt o p racti ce

5 /22 /201

State Boa rdsEducation Law : Article 130 S ub ar ticle 2: 6508

Ap po int ed by t he Boa rd of Reg en t s Assis t th e board of rege n ts and st a t e e du ca t ion

depa rt m en t on matte rs of pr o fess ion al licen sin g,pr a cti ce a nd co ndu ct

Pr e par e ex am in atio ns an d assist the depa rtmentin o th er licen sin g m a tter s as pr e sc ribed by theboa r d of regents

Co nduct di scip lin ary p rocee d ing s an d a ssist ino ther professi o na l co ndu ct m atte rs

Revi ew ap pli cat i on s for l ice nsure

State Board of PharmacyEducation Law : Article 13 7: 6804

Reg ulat e t h e pr ac tice o f p harmac y an d th e emplo ymen t o fintern s a nd em ployees i n p ha rma cies,

Reg u late an d co nt ro l t he sale , dis tr ibut ion, ch ar ac te r an dstandar d of dr u gs, poisons , cos m etics, devices an d n ewd rugs ,

Em pl oy inspectors a nd chemi sts , P rev ent th e sa le o r d is tri buti o n of such drugs , po iso ns,

cos metics , de vices an d new dr u gs as d o n ot conf or m toth e p rov is io ns of this ar t icle or of t h e pu blic heal t h law,

In vesti ga te all ege d violatio ns Iss ue lim ited p e rmits o r regi st ra tio ns .

Change o f Informat ionEducat ion Law: Art icle 130 Sub art icle 1: 650 2

A ddre ss or Name c hange Education law req u ires n o tifi cat io n with in 30

days

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Continuing Educat ionEducati on La w : A rt icle 137: 6 82 7

Re gulat io n s of th e Co mm issio ne r : Pa rt 63 : Pharmacy : 63. 7

Must regi ste r triennially an d comp ly withcontinu ing ed ucation req uir eme nt s

Complete a m inimum of 45 hours No more th a n 22 hours shall cons is t of self-

stud y courses At least 3 hours must b e re lated to m edication

er r ors

Recent graduat es no longer exempt! Exempt on ly if no t engaged in practice

Continuing Education

Collaborati ve Drug Therap y Man age m en t At least 5 hours of formal cont inui ng education

a cce ptab le to th e dep artm e nt in th e area o r a reas ofpr act ice generall y rela ted to any co lla borati ve drugther apy management pr ot o co ls to whi c h th ephar ma cis t ma y be subj ec t

Continuing Education -Record keeping

Must record th e following informat ion foreach co ur se taken: Titl e Number of hours Sp onsor 's name Verification Date an d location

Must be maintain ed for 6 years from th edate co mpl eted

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"accep table fo rmal c on ti nuing ed ucat ion" - formal co urses of

learmn g which con trib ute to p rofe ssional pra ctice in pha rmacyand wh1 ch meet th e standard s pr escribed by regul ati ons of thecom mi ssion er T ec hn iqu es to reduce m edi ca tio n and pre sc ripdoo errors Pharm acology of new a nd deve lopin g dru gs; d ru g int erac t ions Pub lic hea lth issu es Infec t ion co ntro l Ste r ile p rod ucts Lega l an d reg u lat ory issu ts Pa ti en t coun se lin g Ch ild abuse reponi ng O th e r topi c s tha t co n tr ibu te t o rh e p r o f es si o n ~l pra c tice o f ph a rmacy O t h ~r matte rs o f h e~ l t h car e , law , an d e t hi cs th at co ntr ibu te fo t he

public 's h ealth an d wel fa re .


Sp onsors m ust be approved American Council on Pharma ceu t ical

Educati on College s, universities, other degree granting

institutions registered by th e Educati onDepartment or accredit ed by an equi valentagency

Sponsor s approved di r ectly by the Departm ent


One CE cred it equals: 6o minutes or

One contact hour 0 .1 CEU

O ne sem ester hour = 15 conta ct hours= 1.5CEUs = 15 credi ts

On e quarter hour = 1 0 conta ct hou rs = 1. 0CEUs = 10 credit hou rs

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Professional MisconductEducation Law : Article 130 Sub article 3: 6509 - 6511

Obtaining license fraudulently Pra cti cing frau dulentl y, beyond scope of

prac tice, with gross in co mpetenc e, withgross neglig e nce

Practicing w hil e influ e nc ed

Ha bitual u ser of drugs

Unp rofes sional Conduct for HealthProfes siona ls

Rules o f the Board o f Regents : Part 29: 29 .2

Aban donin g or neg lect ing a patient undera nd in need of immediate professional carewithout makin g arrang e ments

Abandoning professiona l e m ploy m en twitho ut reaso nabl e notic e

Willf ull y hara ssin g, ab u s ing or intim idatinga pa t ie nt e it h er ph ys ica lly or verba lly

Fa iling to m aintain a pa t ien t recordacc urately reflect ing treatme nt

Unprofessional Conduct for HealthProfessionals

Orde rin g excess ive tests , treatments, or useof trea tm ent facilities n ot wa r ran ted byco n d iti on

Failing to wear an id ent ificatio n b adge

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Professional Misconduct

Being convi cted of a cr ime Refusin g to p rovid e service s du e to a

person's race, creed, co lo r , or nat io nalor igi n

Allowin g a n un licensed pers on to performprofessi onal activities

Practic ing wi th a suspe n ded license, fa ilingto regi ste r or n otify of name / addressch ange

Unprofessional Conduct for HealthProfe ssionals

Usi ng the wo rd "Doctor" in offe ringprofessional services wi t hou t alsoind icating profession

Faili ng to exercise approp riat e supervisionove r persons over those who are requiredto be superv ised

Guaranteeing sa t isfactio n or a cure w illresul t from performance of profess ionalserv ices

Unprofessional Conduct fo rPharmacists

Rul es of the Board of Rege nts : Part 29: 29.2

Not following reg ul ations for wr ittenprescriptions, labels , medication orde rs ,oral prescr iptio ns , d ispensing aprescript ion, r efill s, subst itu tio ns

Fai lu re to number prescriptions prop erly Failur e to m ain tain appropria te records Fail ur e to mak e pr escri ption d ru g list

ava ilab le

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Unprofessional Conduct fo rPha rma cists

P lacin g in stock a prescriptioncompounded or dispensed after returnedby patient

Selling adul te r ated or m isb randed drugs Selling outdated or improperly stored

drugs

Registrations for EstablishmentsEducati o n Law: Articl e 137 :6808

Required of all individuals , partnerships , orcor poratio ns who possess drugs,prescriptions or poisons for th e purpose ofcomp oun ding , dispe nsin g, retailing,who lesaling, or manufactur ing , or whooffer drugs, pr e scriptions or poisons fo rsale at retail or wholesale

Pharmacy as a Department

Shall be p hys ically separat ed from th e restof the estab lishment Access to de p artme nt is no t avai lable when

ther e is no pharmacist present

Identification of the area shall b e restrictedto th e area licensed by the department aspharmacy

5/22/2013

RULES OF THE PHARMACY

Registrations fo r Establis hmentsEducation Law: Article 137:6808

Regulations o f h ~ Comm ission er: Part 63: 6 3.6 a

Separate regi s tratio n required for each ph armacy An appli catio n for endo rse me nt to another address

shall be m a de no le ss than 30 d ays p ri o r to e xpe c te ddate of r e loc at i o n

Must be consp icuou sly disp layed at all tim es Names of owners con spi cuously di s pl a yed up on th e

e xter ior o f th e establi shment

If ow ne r is n ot a ph a rmacist , mu st bea r na m e o fsupervi sin g pharmaci st

Pharmacy RequirementsRegu lat ion s of th e Comm issioner : Part 63 : 63.6 b

To secure an d retain registration , need atlea st the following : weig hin g device sensitive to 6 mg; metric weights , if ne e de d

devices capable of measuring volumes from 0 .1ml to soo ml; and

a mortar an d pestle .

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Pha rmacy Requi remen t s

Not less t h an 3 0 0 sq u are feet In clude a m an u factur in g, co m p ou n ding a rea of

no t less than 1 00 feet

Equi pp ed wi th storag e faci lit ies p rovidi ngfor safe storage of dr u gs

Ad equate heating, ve n t ilation an d li ghting H ot an d co ld runn i ng water

Phar ma cy Requir e ments

Ph a rm acy as a Departm en t Enclo sed permane nt l y by a pa r t it io n a t least

9'6" unless t he ce ilin g is less than 9'6" Th e partition must be from floor to ceiling

Wh e n no t opened d urin g a ll hours m aintainedby th e esta blishm e n t, a n exterio r sign shouldbe pos t ed clea rly in d icat ing t h e h our s '

Limited Pharma cy Re gistration

Department ma y wa ive any requi rementspertain ing to: Full -time operatio n M inim um equi pm ent

Minimu m space an d waitin g ar ea

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Pharmacy Requi rements

Ref r igerator equ ipped with thermometer(2c-sC)

Co p ies of the laws, ru les and regu lationsgoverni ng the practice of NYS

O ther up -to -date refe rence booksnecessary to carry on practice

Limite d Pha rmac y Reg ist ratio nEducation Law: Arti cle 137:6808

Phar macy within a hospital, nurs ing homeo r extended care faci li ty does no t meet allre qu i reme nts for reg ist ration But can provide high standard of patient safety

wi th good patient care

Pha rm aceutical services shall be li m ited toth e pa t ien ts registe red f or trea t me nt by theva r io us fac ilites

Nonr esi den t Es t a blishm e n t sEducation Law: Article 137 :6808-b

Reg u lations of the Commis s ione r: Part 63 Pharmacy : 63.8

Any pharmacy, m anu facturer, orwh olesaler locate d outs ide of the NYS thatships , mails, or de livers prescr ipt iondr u gs /dev ices to o th er establ ishmen ts,au th or ized p resc rib ers resid ing in NY .

Shall in clude in t e rn et pharmacies

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Nonresident Establishments

Agent o f r ec o rd A designee residing in NY for service of proce ss

Must pr o v id e a toll free number that isavailable during normal business hours and a tleast 40 hours pe r week Enable comm un ication between a pat ient and a

pharmaci st Number mus t be placed on a label affixed to

each drug or devi ce container

Drug Retail Price List

Pharmacy Requirements-RadioactivePart 63: 63 .6 b (6)

Need to m e e t requirements as s tated in 10NYCRR P a r t 16 (med ica l and a cademicfacilities) o r 12 NYCRR Par t 38 (commercialfacilities)

Must ha ve appropr ia te lice ns e issu ed byNYS Dept. o f Health or Labor

Pharmacy Requirements-Radioactive

Shall also be equipped with th e following: Laminar flow hood Dose calibr ato r Exhaust hood and folter system Chromatography apparatus Apparatu s or mate rials for the dete rmination of pH Single-channel and /or multi channel scintill ation

detect ion system Microsco pe

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Nonresident Establishments

Registration requirements Licensed an d registered in state of origin Maintain records in readily retrievable form

Supply information upon r equest Co mpl y w it h all statutory an d regulato ry

requir emen ts of residing stat e for prescriptiondrugs or devi ces shipped, mailed or deliver edinto NY

For CS must follow federal and NY law

Pharmacy Requirements -Radioactive

O n e pharmacist should be presen t a t allhours when th e pharmacy is openm ee ting:

Minimal standards o f raining a nd experience

Submitted to th e state board ei t he r : Certification as Nuclear Pharmacists by BPS Completion of minimum 2 0 0 contac t hours of

didactic instru ction in nuclear pharma cy and aminimum of soo hour s training unde r thesupervision of a board certified nuclear pharmacistin a cert ified nuclear residen cy/t raining program

Pharmacy ConductEdu cation Law: Ar ti cle 137 :6808

Every owne r o f a pharmacy or everypharmacist in charge o f a pharmacy sh a llbe responsible fo r the p roper conduc t ofthis pharmacy.

A pharmacist m u s t b e present a t al l hoursw h e n op e n

O ne pharmacy per supervising pharma c is t

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Supervis ing Pharmac istRules of the Board of Regents Part 29: 29 .7a (10)

Ed uca tion Law: Article 137: 6808

Each registered pharmacy must be unde rthe supervision of a registered phar mac ist

The SP is responsible for ensuringcomp li a n ce of all rules an d regu lations

Oversees all employees of the pharmacy May no t as sign responsibility to others Must have active ro le in phar m acy

Change of Supervisor

The owner shall notify the department withthe name of th e rep lacement pharmacist

Apply for an amended registration Attac h to origina l registration

Both owner an d supervising pharmacistshall be responsible for carrying this ou t

Must be done within 7 days of change

Phar m a cy Intern

May practic e as a pharmacist under theimmediate personal supervision of apharmacist When a prescript ion is dispensed by an intern,

must have both intern 's and pharma cist'sinitials

5/2 2/201

Supervising Pharmac ist

Must practice at p harm ac y full ti m e At lea st 30 hours a week

If pharmacy is open less than 30 hours aweek : Must be pr es en t fo r th e majority of hours

Pharmacy InternEducation Law : Article 137:6806

Lim ited permit auth orizi ng the practice ofpharmacy unde r th e immediate an dpersonal supervision of a registeredpharmacist Must have co mplet ed first year of prof ession al

study OR A gr a duate of a pharmacy prog r a m wh o is

engaged in meetin g th e experiencerequir ements or whose application is pendin g

Expiration dat e of 5 years

Pre cep t or PharmacistPart 63: 63.2a (3A)

Must have practiced at least one year

Cannot supervise no more than one fulltime in tern or two part- t ime interns

In pharmacy training interns , one internfor each sooo prescriptions disp ensedannua lly

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Unlicensed Assi stantsPart 29: 29 .7a ( 21)

Does no t includ e interns, staff no t directlyrelated to th e filling of pr escr iptio n s

Up to two unlicensed persons may assist apharmacist

Unl icensed Assistants- AllowedTo ...

Count dosage units o f drugs Place d os age units of drugs in appropriate

conta iners Affix th e prescription lab e l to th e contai ners Prepare manual records of di spe nsin g for th e

signa tu re or initia ls o f th e p h armacist Hand or deliver comp leted pr escriptio ns to th e

pa t ien t or th e person a u thorized to ac t on behalfof he pat ien t

Unlice nsed Assistants- NotAllowed To ..

Measure, weigh, co mp o und or mixin gredients

Sign or initi a l an y record of dispe nsi ngreq ui re d to be maintained by law

Counse l pa t ients Perform any other function inv olvi ng th e

exer cise of professio n al judgment

5/22/2013

Unlicensed Assistants- AllowedTo ..

Rece ive written or elec tr o nicall y t r ansm ittedprescriptions , except that in th e case ofelectron ically transmitted p rescriptions

Type p rescrip t io n la bel s Key prescription data for e nt ry in to a computer

generated file or r et riev in g prescription data fromth e file

Get drugs from stock an d returning them to stoc k Get prescripti on files an d other manual records

from st orage an d lo cating prescript ions;

Unlicensed Assistants- NotAllowed To . ..

Receive oral p re sc rip tio n s fro m prescribers Interp re t an d eva luate a pr escr ipt ion for

confo rman c e with legal requirements,au then tici ty, accuracy an d interaction ofth e prescribed drug with ot her know nprescr ibe d an d over - the-counte r drugs

Make determinat io ns of the th erape uticequ ivalency as suc h determi na tio ns ap p lyto ge n er ic s ubsti tu ti on

Reporting Requi re men ts

Transfer of ow ners hi p At leas t 6 weeks pr ior to proposed da t e

Change in corporate offic er s an d / orprinc ipal stockho lders Not ifY within 30 days

Fire, flo od , disast er W ithin 48 hours of damage

Chang e in Supervisor Within 7 da ys of an y change

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Reporting Requirements

Change of location Not less than 30 days prior to th e expecte ddate or r elocat ion

Renov at ions Should be reported prior t o an y renovations

Change in corporate name Notify prior to u se o f any ne w nam e

Drug Retail Price ListEducation Law: Article 137:6826

Regulations of he Commissioner: Part 63, Pharmacy:63.6(9)

Sign posted no t ifyi ng patients of the ava ilability ofa drug re tail price list "Drug Retail Price List Availabl e Upon Request" in

bold, block letters of at least on e inch in height Drugs on list provided by the board of pharmacy 15 0 most frequently prescribed drugs

Updated week ly Conta in advisory statement

Need to tell heal th care practitioner and pharmac istabout medications/avoidance of harmful int eractio ns

Prescriptive Author ityPRESCRIPTIONS

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Reporting Requirements

Tem po ra ry closing No ti fy prior to any su c h closing as well as priorto reopening

Sale of drugs at Auction Must be not ified at le as t seven days prior to

auction

Drug Retail Price Li st

Retail p rice means the actual price to bepaid

We b- based pharmacies must post Notice of th e availability

Provide a toll-free number

Ma il -order pharmacies Provide a printed notice with each d elivery

infor m ing the patient abou t t h e availabilty

Provide a t oll -fr ee number

Prescription

A prescription shall be issued by apractitioner fo r legitimate medical purposesin good faith an d in the course of his or her

professio nal prac tice only.

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Who Can Prescribe?

Tradi ti ona l Prescribers Doctor of Me di cine (M.D.) Doctor o f Osteopa th y (D.O.) Doc to r of Den ta l Surgery ( D.D.S.) Doctor of Dent a l Medicin e (D.D.M.) Doctor of Podiatric Medicine (D .P.M.)

Doctor of Ve t erinary Me di cin e (D.V.M .)

Midwife

Ma n age m ent of n ormal p re gn a nci es, c hil dbirth and postpartum care as we ll asprim ary preventive reproductive hea lthcare of es se ntiall y heal t hy women

Includ e n ewborn eva lu ation, r esuscitationand referral for infan ts

Midwife

May pre scr ib e an d admini ster drugs ,immunizing agents, diagnostic test s a ndo rde r lab tests limited to the practice Include s co nt r olled substances

Register with stat e License numb e r begins wit h F + 6 digi ts

Own prescription blanks

5 / 22/2013

Who Can Prescribe?

Under certa in c onditi o ns : Midwife Nur se p rac titi one r (NP) Ce rti fied o ptome tris t

Registered ph ysici an assis t an t (R. P.A.)

Those not allowed: Doctor of Op to m e try (O.D .) (u n less cert ified) Doctor of Chiroparacti c Medicine (D.C.) Op ti cian o r O phth a lmi c di spenser

Midwife

Midwifery sha ll be practiced in accordancew it h a written agreement between th emidwife : A lice nse d ph ys ician w ho is board certified as

anOB / GYN

A licensed physician wh o p ractices obstetricsa nd h as o bs t etric privileges a t a hospi ta l

A hospital th a t provides obstetrics th r oug h alic en sed ph ys ician

Nurse Practitioners

Obtain a certificate from th e departmentup on su ccess full y co mpletin g a programincluding an appropriate pharmacologycomponent, or its equivalent

Must ha ve collaboration wit h a physician Must be ke pt on file with th e p hysicia n , with

t he State Edu ca tion Department an d at theNP's p ractice site

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Nurse Practitioners

May p rescrib e for contr olled substances Must ha ve D EA n umber

Li ce nse regi st ration will beg in with an F + 6digits Fi rs t two di gi ts represent spec ial ty area

May have own prescripti o n blank s wi thn am e an d desig nation im printe d

Optometrist

Must be certified by NYS Edu c ationDepart m ent

Those wh o are cert ifi ed ca n b e identified byletter pr eced in g th eir license num be r: T = diagn ostic age nt s U = Phase O ne agents

V = an y a ge nt

Own pres cr ip tion blan k

Optometrist - Phase On e

Completed at least 30 0hours of dinicalt:raining inthe diagnos is, creatment andman ageme nt of patien tswith oc ular disease ot herthan glaucoma and ocu lar

hyp ertension Successfu lly pa ssed th e

t:reaonent and managementof ocular diseases po rt ion ofthe Nat iona l Board ofExam iners in Optometry test

Antibiotics Decong estants /anti

a ll ergenics NSAIDs Ste roidal anti -

inflam matories Antivira ls Hyperosmotics/hypertonics Cyclopleg ics Artificial tear s and

lubricants

Op t ometrist

Optometrists who h ave satisfactorilyco mpl eted a curriculum in general andoc ular pharmaco logy at a college ofop t ometry w ith d ida ctic a n d sup erv isedclinical prog rams approved by thedepartment are elig ible to apply forprescri ptive authority

Optometris t- Diagnostic Agents

Mydriatics Mio tics Cyclop legics Anes thetics

Optometrist - Phase Two

Must be certified fordiagnostic and phase on etherapeutic agents

Completed an additionalone hundred hours ofclinicalt:rain ing in thediagnosis, t:reat:rnent an dmanagement of pa t ientswith glaucoma an d ocu larhype rtension

Success full y passed an ora lor written examina t io naccep ta ble by the boa rd

Alpha -agonists Beta -blockers D irect acting

cholin erg ics

5/22 /201

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Physician AssistantNYS Public Health Law : Article 37: 370 2

A dependent practitioner working underth e su pe rvision of a licensed physicianresponsible for the actions of th e P.A.

If de legat ed by physici an, may writem ed ica l o rders an d prescripti ons In pa t ien t : ma y orde r m ed icati o ns , incl uding

C II - V (may require ph y sician 'sco un t ers ignatur e within 24 hours)

Outpatient: ma y prescribe m edicationsincluding CII-V

Obligation to Fill a Prescription

Pharmaci s ts ma y refuse to fill or refill apre scription for go od rea son , including: Drug ou t of sto ck Suspect th e pr escript ion is for ge d Belie v e that th e medi ca ti o n wi ll be harmful to

th e pati e nt Know t h at th e ref i llin g of th e pr escription

vio lates the law

Patient ProfilesPart 63: 63.6b (7)

Mu s t inclu de but not lim ited to ; Na m e, addr ess, ph o ne o f pat ien t Gen der and dat e of birth Kn ow n allergies /drug int erac tions Ch ronic di seases Com pr ehe nsive list of med ications a nd relevant

devices Ot h er in f or mati on reported to th e ph ar maci st

appropriat e for counseli ng the pati en t rega rd ing th euse of pr esc ripti o ns a nd OTC dru gs

5/22 /2013

Who May Dispense?

Pharmaci st acting in th e u sua l course ofprofessional pract ice Registered in d ivid u a lly or employ ed b y a

registe r ed ph a rmacy or regi ste red in s tituti o na lp ractitione r.

Includes those individuals a u th or ize d todi spense under the supervision of aphar mac ist (varies from state to state)

Patie n t Pro fil es

PRESCRIPTIONS

Prospective Drug Review

A prospective drug review is to be do n e prior toth e dispensing of ea ch prescription

Th e review sha ll includ e screening for p ot e nt i a ldrug th er apy pr oblem s due to:

Therapeuti c dupli cat ion Dru g-d isease co nt raind ications Drug-drug interact ions ( incl u ding OTCs) Incorre ct drug dosage or du ration of th e rap y Drug -all ergy in te r actions Clini cal abuse/misuse

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