federal guidance on emergeny drug kits containing ... kit compliance overview provided to dopl on...

29
••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• Emergency Kit Compliance Overview Provided to DOPL on 2/12/2014 by Jared Memmott Federal Guidance on Emergeny Drug Kits Containing Controlled Substances http;llwwvv.deadiversion.usdoj.gov/faq/general.htm (Frequently Asked Questions from DEA Diversion website) http;llwww.deadiversion.usdoLgov/fed regs/notices/other/fr 0409l980.pdf (Original publication of in the Federal Register / Vol. 45, No 70/ Wednesday, April 9, 1980) Question: Can aft LTCF store cofttrolled substaftces ift aft emergency kit without being registered with DEA? Answer: DEA published the following Statement of Policy in the April 9, 1980 Federal Register regarding the placement of controlled substances in an emergency kit located in an LTCF. STATEMENT OF POLICY The placement of emergency kits containing controlled substances in non-federally registered Long Term Care Facilities (LTCF) shall be deemed to be in compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970, if the appropriate state agency or regulatory authority specifically approves such placement and promulgates procedures which delineate: A. The source from which an LTCF may obtain controlled substances for emergency kits. The source of supply must be a DEA registered hospitaUclinic, pharmacy, or practitioner. B. Security safeguards for each emergency kit stored in the LTCF which include the designation of Individuals who may have access to the emergency kits and a specific I imitation of the type and quantity of controlled substances permitted to be placed in each emergency kit. C. Responsibility for proper control and accountability of such emergency kits within the LTCF to include the requirement that the LTCF and the providing DEA registered hospital/clinic, pharmacy, or practitioner maintain complete and accurate records of the controlled substances placed in the emergency kit, the disposition of these controlled substances plus the requirement to take periodic physical inventories. D. The emergency medical conditions under which the controlled substances may be administered to patients in the LTCF to include the requirement that medication be administered by authorized personnel only as expressly authorized by an individual practitioner and in compliance with the provisions of21 CFR 1306.11 and 21 CFR 1306.21. E. Prohibited activities which can result in the state revocation, denial, or suspension of the privilege of having or placing emergency kits, containing controlled substances, in an LTCF. IMPORTANT POINTS 21 CFR 1306.11; pertains to the requirements of a CII prescription and only being able to dispense a prescription pursuant to a prescription. 21 CFR 1306.21; pertains to the requirements of a CIII-V prescription and only being able to dispense a prescription pursuant to a prescription. Page 1 of 5

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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

Federal Guidance on Emergeny Drug Kits Containing Controlled Substances

httpllwwvvdeadiversionusdojgovfaqgeneralhtm (Frequently Asked Questions from DEA Diversion website)

httpllwwwdeadiversionusdoLgovfed regsnoticesotherfr 0409l980pdf (Original publication of in the Federal Register Vol 45 No 70 Wednesday April 9 1980)

Question Can aft LTCF store cofttrolled substaftces ift aft emergency kit without being registered with DEA

Answer DEA published the following Statement of Policy in the April 9 1980 Federal Register regarding the placement of controlled substances in an emergency kit located in an LTCF

STATEMENT OF POLICY

The placement of emergency kits containing controlled substances in non-federally registered Long Term Care Facilities (LTCF) shall be deemed to be in compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970 if the appropriate state agency or regulatory authority specifically approves such placement and promulgates procedures which delineate

A The source from which an LTCF may obtain controlled substances for emergency kits The source of supply must be a DEA registered hospitaUclinic pharmacy or practitioner

B Security safeguards for each emergency kit stored in the LTCF which include the designation of Individuals who may have access to the emergency kits and a specific Iimitation of the type and quantity of controlled substances permitted to be placed in each emergency kit

C Responsibility for proper control and accountability of such emergency kits within the LTCF to include the requirement that the LTCF and the providing DEA registered hospitalclinic pharmacy or practitioner maintain complete and accurate records of the controlled substances placed in the emergency kit the disposition of these controlled substances plus the requirement to take periodic physical inventories

D The emergency medical conditions under which the controlled substances may be administered to patients in the LTCF to include the requirement that medication be administered by authorized personnel only as expressly authorized by an individual practitioner and in compliance with the provisions of21 CFR 130611 and 21 CFR 130621

E Prohibited activities which can result in the state revocation denial or suspension of the privilege of having or placing emergency kits containing controlled substances in an LTCF

IMPORTANT POINTS

~ 21 CFR 130611 pertains to the requirements of a CII prescription and only being able to dispense a prescription pursuant to a prescription

~ 21 CFR 130621 pertains to the requirements of a CIII-V prescription and only being able to dispense a prescription pursuant to a prescription

Page 1 of 5

Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

Emergency Kit Guidance from the American Society of Consultant Pharmacists

Question When is a nurse authorized to remove a controlled drug from an e-kit

Answer Controlled drugs in e-boxes are treated the some way as all other conrrolled drugs Before a drug can be removed there must be a volid written prescription Iwhich may be a fax unless the emergency exception applies E-boxes should never be used routinely to dispense drugs that should hove been reordered Raiher e-boxes should be used only for unanticipated emergendes that may be a new admission or a new order Due to the importance of state law in authorizing the use of eshykits in long-term care it is critical that practitioners pharmacists and facilities understond all pertishynent stole lows and regulotions governing e-kits in oddition to federal requirements

Question What are the potential consequences if nurse take a controlled drug from e-kit before the practitioner has issued a valid prescription

Answer Taking possession of a controlled drug without proper authorization con be a serious offense A nurse who removes a controlled drug from on e-kit without volid authorization may be subject to civil and criminal fines and penalties disciplinary action by the state licensing board and exclusion from federal health core programs

Question Is it permissible for a nurse to remove a controlled drug from an e-kit if slhe has received an oral order from the practitioner

Answer Some states permit this practice However DEA rules require that the practitioner provide oral authorization or a foxed prescription to the pharmacist before a drug is dispensed Consequently a practitioner who gives an oral order to the nurse in the facility by telephone must

also ensure that the pharmacy receives either an oral emergency order or a written prescription order (which may be sent via facsimile)

Question Can a nurse in a long-term care facility remove drugs from an E-kit based upon a standing order

Answer No An e-kit should only used in an emergency situation which by definition must be unanticipated

Question Can a nurse remove a CII from an e-kit for a patient who already has a valid prescription for a ell drug but has run out of medication at 200 am

Assuming this situation meets the criteria for an emergency situation the nurse would need to contact the practitioner for an orol authorization (which must be communicated by the pradifQner to the pharmacist either orally or by fax) While these situations sometimes cannot be avoided nursing facilities and pharmacies should hove systems in pJoce that ensure the timely reshyordering of medications for patients with on-going need for pain management

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Page 2 of 5

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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

Conflicts with Current Utah Statute

The Utah Controlled Substance Act in UCA sect 58-37-6 (2)(e) states

A separate license is reg uired at each principal place of business or professional practice where the applicant manufactures produces distributes dispenses conducts research with or performs laboratory analysis upon controlled substances

The Utah Pharmacy Practice Act in U CA sect 58-17b-302(3) states

Each place of business shall require a separate license If multiple pharmacies exist at the same address a separate license shall be required for each pharmacy

Conflicts with Current Utah Administrative Rules

R432 Health Family Health and Preparedness Licensing

Rule R432-1 50 Nursing Care Facility

R432-150-19 Pharmacy Services

(1) The facility must provide or obtain by contract routine and emergency drugs biologicals and pharmaceutical

services to meet resident needs

(2) The facility must employ or obtain the services of a licensed pharmacist who

(a) provides consultation on all aspects of pharmacy services in the facility

(b) establishes a system of records of receipt and disposition of all controlled substances which documents an

accurate reconciliation and

(c) determines that drug records are in order and that an account of all controlled substances is maintained and

reconciled monthly_

(3) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist

(a) The pharmacist must report any irregularities to the attending physician and the director of nursing or health

services supervisor

(b) The physician and the director of Nursing or health services supervisor must indicate acceptance or rejection of

the report and document any action taken

(4) Pharmacy personnel must ensure that labels on drugs and biologicals are in accordance with currently accepted professional principles and include the appropriate accessory and cautionary instructions and the expiration date

(5) The facility must store all drugs and biologicals in locked compartments under proper temperature controls according to R432- I 50- I 9 (6)e) and permit only authorized personnel to have access to the keys

Page 3 of 5

Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

(a) The facility must provide separately locked permanently affixed compartments for storage of controlled substances listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse except when the facility uses single unit dose package drug distribution systems in which the

quantity stored is minimal and a missing dose can be readily detected

(b) Non-medication materials that are poisonous or caustic may not be stored with medications

(c) Containers must be clearly labeled

(d) Medication intended for internal use shall be stored separately from medication intended for external use

(e) Medications stored at room temperature shall be maintained within 59 and 80 degrees F

() Refrigerated medications shall be maintained within 36 and 46 degrees F

(6) The facility must maintain an emergency drug supply

(a) Emergency drug containers shall be sealed to prevent unauthorized use

(b) Contents of the emergency drug supply must be listed on the outside of the container and the use of contents shall be documented by the nursing staff

(c) The emergency drug supply shall be stored and located for access by the nursing staff

(d) The pharmacist must inventory the emergency drug supply monthly

(e) Used or outdated items shall be replaced within 72 hours by the pharmacist

(7) The pharmacy must dispense and the facility must ensure that necessary drugs and biologicals are

provided on a timely basis

(8) The facility must limit the duration of a drug order in the absence of tbe prescribers specific

instructions

(9) Drug references must be available for all drugs used in the facility References shall include generic and brand

names available strength and dosage forms indications and side effects and other pharmacological data

(10) Drugs may be sent with the resident upon discharge if so ordered by the discharging physician provided

tbat

(a) such drugs are released in compliance R156-17a-619 and

(b) a record of the drugs sent with the resident is documented in the residents health record

(II) Disposal of controlled substances must be in accordance with the Pharmacy Practice Act

Page 4 of 5

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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

IMPORTANT POINTS

~ The practice of pharmacy definition and the above described statute prohibit anyone other than a properly licensed pharmacy from possessing stock controlled substances or legend drugs

~The Utah Department of Health has invalid and antiquated administrative rules that supersedes what statute does not allow and existing pharmacy law and rule does not even address some of the operating standards mandated by the pharmacist and pharmacy who are providing pharmacy services

~As the Federal Register states that emergency kits in Long Term Care Facilities are only viewed as compliant with the Controlled Substance Act IF the appropriate state agency or regulatory authority specifically approves such placement anltLQ()lgates procedures which delineate The Utah Department of Health is not the appropriate state agency and moreover the appropriate Utah statute conflicts with the inappropriate state agency administrative rules

~ Additionally the existing administrative rules do not define and cover everything mandated in the Federal Register to even be considered compliant

Page 5 of 6

State of Utah Department of Comnlerce Division of Occupational and Professional Licensing

GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director

GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT

Approved by the Board of Pharmacy May 21 2012

The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include

bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled

substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)

bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and

bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203

NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated

After-hours Medications Taken from Pharmacy When a Pharmacy is Closed

Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours

wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH

Dispensing of Drugs from an Emergency Room

bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount

The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days

bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use

bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD

NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610

Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics

or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution

Federal Statute

According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)

USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but

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dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance

USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration

wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301

LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct

ct 02-05-14 1 56 PM ct

1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Bradley G Last

6

7 LONG TITLE

8 General Description

9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy

10 technicians

11 Highlighted Provisions

12 This bill

13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have

14 access to the database on behalf of the phannacist in accordance with statutory

15 requirements

16 Money Appropriated in this Bill

17 None

18 Other Special Clauses

19 None

20 Utah Code Sections Affected

21 AMENDS

22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262

23

24 Be it enacted by the Legislature ofthe state ofUtah

25

26

27

Section 1 Section 58-37fmiddot301 is amended to read

58-37fmiddot301 Access to database

(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah

rJlbull =bull

1111111111111111111111111111111111111111

02-05-14 156 PM SB178

59 (A) fit within the responsibilities of the Department of Health for health and welfare

60 (B) are reviewed and approved by an Institutional Review Board that is approved for

61 human subject research by the United States Department of Health and Human Services and

62 (C) are not conducted for profit or commercial gain and

63 (D) are conducted in a research facility as defined by division rule that is associated

64 with a university or college in the state accredited by the Northwest Commission on Colleges

65 and Universities

66 (iii) the designee protects the information as a business associate of the Department of

67 Health and

68 (iv) the identity of the prescribers patients and pharmacies in the database are

69 de-identified confidential not disclosed in any manner to the designee or to any individual

70 who is not directly involved in the scientific studies

71 (e) a licensed practitioner having authority to prescribe controlled substances to the

72 extent the information

73 (i) (A) relates specifically to a current or prospective patient of the practitioner and

74 (B) is provided to or sought by the practitioner for the purpose of

75 (I) prescribing or considering prescribing any controlled substance to the current or

76 prospective patient

77 (II) diagnosing the current or prospective patient

78 (nn providing medical treatment or medical advice to the current or prospective

79 patient or

80 (IV) determining whether the current or prospective patient

81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner

82 or

83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled

84 substance from the practitioner

85 (ii) (A) relates specifically to a fonner patient of the practitioner and

86 (B) is provided to or sought by the practitioner for the purpose of determining whether

87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a

88 controlled substance from the practitioner

89 (iii) relates specifically to an individual who has access to the practitioners Drug

- 3 shy

02-05-14 156 PM SB178

121 58-3 7f-203(3 )(b) with respect to the employee

122 (h) a licensed pharmacist having authority to dispense a controlled substance to the

123 extent the information is provided or sought for the purpose of

124 (i) dispensing or considering dispensing any controlled substance or

125 (ii) determining whether a person

126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or

127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled

128 substance from the pharmacist

129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an

]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in

131 Subsection (2)(h)(i) or (iO if

132 0) the employee is designated by the pharmacist-in-charge as an individual authorized

133 to access the information on behalf of a licensed pharmacist employed by the pharmacy

134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of

135 the employee and

136 (iii) the division

137 CA) grants the employee access to the database and

138 (B) provides the employee with a password that is unique to that employee to access

139 the database in order to permit the division to comply with the requirements of Subsection

140 58-37f-203(3)(b) with respect to the employee

141 [fiJ] ill federal state and local law enforcement authorities and state and local

142 prosecutors engaged as a specified duty of their employment in enforcing laws

143 (i) regulating controlled substances

144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or

145 (iii) providing information about a criminal defendant to defense counsel upon request

146 during the discovery process for the purpose of establishing a defense in a criminal case

147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the

148 Department of Health who are engaged in their specified duty of ensuring Medicaid program

149 integrity under Section 26-18-23

150 [fki] ill a mental health therapist if

151 (i) the information relates to a patient who is

- 5 shy

02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

- 7

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

Emergency Kit Guidance from the American Society of Consultant Pharmacists

Question When is a nurse authorized to remove a controlled drug from an e-kit

Answer Controlled drugs in e-boxes are treated the some way as all other conrrolled drugs Before a drug can be removed there must be a volid written prescription Iwhich may be a fax unless the emergency exception applies E-boxes should never be used routinely to dispense drugs that should hove been reordered Raiher e-boxes should be used only for unanticipated emergendes that may be a new admission or a new order Due to the importance of state law in authorizing the use of eshykits in long-term care it is critical that practitioners pharmacists and facilities understond all pertishynent stole lows and regulotions governing e-kits in oddition to federal requirements

Question What are the potential consequences if nurse take a controlled drug from e-kit before the practitioner has issued a valid prescription

Answer Taking possession of a controlled drug without proper authorization con be a serious offense A nurse who removes a controlled drug from on e-kit without volid authorization may be subject to civil and criminal fines and penalties disciplinary action by the state licensing board and exclusion from federal health core programs

Question Is it permissible for a nurse to remove a controlled drug from an e-kit if slhe has received an oral order from the practitioner

Answer Some states permit this practice However DEA rules require that the practitioner provide oral authorization or a foxed prescription to the pharmacist before a drug is dispensed Consequently a practitioner who gives an oral order to the nurse in the facility by telephone must

also ensure that the pharmacy receives either an oral emergency order or a written prescription order (which may be sent via facsimile)

Question Can a nurse in a long-term care facility remove drugs from an E-kit based upon a standing order

Answer No An e-kit should only used in an emergency situation which by definition must be unanticipated

Question Can a nurse remove a CII from an e-kit for a patient who already has a valid prescription for a ell drug but has run out of medication at 200 am

Assuming this situation meets the criteria for an emergency situation the nurse would need to contact the practitioner for an orol authorization (which must be communicated by the pradifQner to the pharmacist either orally or by fax) While these situations sometimes cannot be avoided nursing facilities and pharmacies should hove systems in pJoce that ensure the timely reshyordering of medications for patients with on-going need for pain management

I bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull

Page 2 of 5

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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

Conflicts with Current Utah Statute

The Utah Controlled Substance Act in UCA sect 58-37-6 (2)(e) states

A separate license is reg uired at each principal place of business or professional practice where the applicant manufactures produces distributes dispenses conducts research with or performs laboratory analysis upon controlled substances

The Utah Pharmacy Practice Act in U CA sect 58-17b-302(3) states

Each place of business shall require a separate license If multiple pharmacies exist at the same address a separate license shall be required for each pharmacy

Conflicts with Current Utah Administrative Rules

R432 Health Family Health and Preparedness Licensing

Rule R432-1 50 Nursing Care Facility

R432-150-19 Pharmacy Services

(1) The facility must provide or obtain by contract routine and emergency drugs biologicals and pharmaceutical

services to meet resident needs

(2) The facility must employ or obtain the services of a licensed pharmacist who

(a) provides consultation on all aspects of pharmacy services in the facility

(b) establishes a system of records of receipt and disposition of all controlled substances which documents an

accurate reconciliation and

(c) determines that drug records are in order and that an account of all controlled substances is maintained and

reconciled monthly_

(3) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist

(a) The pharmacist must report any irregularities to the attending physician and the director of nursing or health

services supervisor

(b) The physician and the director of Nursing or health services supervisor must indicate acceptance or rejection of

the report and document any action taken

(4) Pharmacy personnel must ensure that labels on drugs and biologicals are in accordance with currently accepted professional principles and include the appropriate accessory and cautionary instructions and the expiration date

(5) The facility must store all drugs and biologicals in locked compartments under proper temperature controls according to R432- I 50- I 9 (6)e) and permit only authorized personnel to have access to the keys

Page 3 of 5

Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

(a) The facility must provide separately locked permanently affixed compartments for storage of controlled substances listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse except when the facility uses single unit dose package drug distribution systems in which the

quantity stored is minimal and a missing dose can be readily detected

(b) Non-medication materials that are poisonous or caustic may not be stored with medications

(c) Containers must be clearly labeled

(d) Medication intended for internal use shall be stored separately from medication intended for external use

(e) Medications stored at room temperature shall be maintained within 59 and 80 degrees F

() Refrigerated medications shall be maintained within 36 and 46 degrees F

(6) The facility must maintain an emergency drug supply

(a) Emergency drug containers shall be sealed to prevent unauthorized use

(b) Contents of the emergency drug supply must be listed on the outside of the container and the use of contents shall be documented by the nursing staff

(c) The emergency drug supply shall be stored and located for access by the nursing staff

(d) The pharmacist must inventory the emergency drug supply monthly

(e) Used or outdated items shall be replaced within 72 hours by the pharmacist

(7) The pharmacy must dispense and the facility must ensure that necessary drugs and biologicals are

provided on a timely basis

(8) The facility must limit the duration of a drug order in the absence of tbe prescribers specific

instructions

(9) Drug references must be available for all drugs used in the facility References shall include generic and brand

names available strength and dosage forms indications and side effects and other pharmacological data

(10) Drugs may be sent with the resident upon discharge if so ordered by the discharging physician provided

tbat

(a) such drugs are released in compliance R156-17a-619 and

(b) a record of the drugs sent with the resident is documented in the residents health record

(II) Disposal of controlled substances must be in accordance with the Pharmacy Practice Act

Page 4 of 5

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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

IMPORTANT POINTS

~ The practice of pharmacy definition and the above described statute prohibit anyone other than a properly licensed pharmacy from possessing stock controlled substances or legend drugs

~The Utah Department of Health has invalid and antiquated administrative rules that supersedes what statute does not allow and existing pharmacy law and rule does not even address some of the operating standards mandated by the pharmacist and pharmacy who are providing pharmacy services

~As the Federal Register states that emergency kits in Long Term Care Facilities are only viewed as compliant with the Controlled Substance Act IF the appropriate state agency or regulatory authority specifically approves such placement anltLQ()lgates procedures which delineate The Utah Department of Health is not the appropriate state agency and moreover the appropriate Utah statute conflicts with the inappropriate state agency administrative rules

~ Additionally the existing administrative rules do not define and cover everything mandated in the Federal Register to even be considered compliant

Page 5 of 6

State of Utah Department of Comnlerce Division of Occupational and Professional Licensing

GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director

GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT

Approved by the Board of Pharmacy May 21 2012

The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include

bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled

substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)

bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and

bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203

NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated

After-hours Medications Taken from Pharmacy When a Pharmacy is Closed

Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours

wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH

Dispensing of Drugs from an Emergency Room

bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount

The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days

bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use

bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD

NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610

Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics

or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution

Federal Statute

According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)

USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but

~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-

dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance

USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration

wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301

LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct

ct 02-05-14 1 56 PM ct

1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Bradley G Last

6

7 LONG TITLE

8 General Description

9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy

10 technicians

11 Highlighted Provisions

12 This bill

13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have

14 access to the database on behalf of the phannacist in accordance with statutory

15 requirements

16 Money Appropriated in this Bill

17 None

18 Other Special Clauses

19 None

20 Utah Code Sections Affected

21 AMENDS

22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262

23

24 Be it enacted by the Legislature ofthe state ofUtah

25

26

27

Section 1 Section 58-37fmiddot301 is amended to read

58-37fmiddot301 Access to database

(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah

rJlbull =bull

1111111111111111111111111111111111111111

02-05-14 156 PM SB178

59 (A) fit within the responsibilities of the Department of Health for health and welfare

60 (B) are reviewed and approved by an Institutional Review Board that is approved for

61 human subject research by the United States Department of Health and Human Services and

62 (C) are not conducted for profit or commercial gain and

63 (D) are conducted in a research facility as defined by division rule that is associated

64 with a university or college in the state accredited by the Northwest Commission on Colleges

65 and Universities

66 (iii) the designee protects the information as a business associate of the Department of

67 Health and

68 (iv) the identity of the prescribers patients and pharmacies in the database are

69 de-identified confidential not disclosed in any manner to the designee or to any individual

70 who is not directly involved in the scientific studies

71 (e) a licensed practitioner having authority to prescribe controlled substances to the

72 extent the information

73 (i) (A) relates specifically to a current or prospective patient of the practitioner and

74 (B) is provided to or sought by the practitioner for the purpose of

75 (I) prescribing or considering prescribing any controlled substance to the current or

76 prospective patient

77 (II) diagnosing the current or prospective patient

78 (nn providing medical treatment or medical advice to the current or prospective

79 patient or

80 (IV) determining whether the current or prospective patient

81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner

82 or

83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled

84 substance from the practitioner

85 (ii) (A) relates specifically to a fonner patient of the practitioner and

86 (B) is provided to or sought by the practitioner for the purpose of determining whether

87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a

88 controlled substance from the practitioner

89 (iii) relates specifically to an individual who has access to the practitioners Drug

- 3 shy

02-05-14 156 PM SB178

121 58-3 7f-203(3 )(b) with respect to the employee

122 (h) a licensed pharmacist having authority to dispense a controlled substance to the

123 extent the information is provided or sought for the purpose of

124 (i) dispensing or considering dispensing any controlled substance or

125 (ii) determining whether a person

126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or

127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled

128 substance from the pharmacist

129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an

]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in

131 Subsection (2)(h)(i) or (iO if

132 0) the employee is designated by the pharmacist-in-charge as an individual authorized

133 to access the information on behalf of a licensed pharmacist employed by the pharmacy

134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of

135 the employee and

136 (iii) the division

137 CA) grants the employee access to the database and

138 (B) provides the employee with a password that is unique to that employee to access

139 the database in order to permit the division to comply with the requirements of Subsection

140 58-37f-203(3)(b) with respect to the employee

141 [fiJ] ill federal state and local law enforcement authorities and state and local

142 prosecutors engaged as a specified duty of their employment in enforcing laws

143 (i) regulating controlled substances

144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or

145 (iii) providing information about a criminal defendant to defense counsel upon request

146 during the discovery process for the purpose of establishing a defense in a criminal case

147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the

148 Department of Health who are engaged in their specified duty of ensuring Medicaid program

149 integrity under Section 26-18-23

150 [fki] ill a mental health therapist if

151 (i) the information relates to a patient who is

- 5 shy

02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

- 7

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

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bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull

Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

Conflicts with Current Utah Statute

The Utah Controlled Substance Act in UCA sect 58-37-6 (2)(e) states

A separate license is reg uired at each principal place of business or professional practice where the applicant manufactures produces distributes dispenses conducts research with or performs laboratory analysis upon controlled substances

The Utah Pharmacy Practice Act in U CA sect 58-17b-302(3) states

Each place of business shall require a separate license If multiple pharmacies exist at the same address a separate license shall be required for each pharmacy

Conflicts with Current Utah Administrative Rules

R432 Health Family Health and Preparedness Licensing

Rule R432-1 50 Nursing Care Facility

R432-150-19 Pharmacy Services

(1) The facility must provide or obtain by contract routine and emergency drugs biologicals and pharmaceutical

services to meet resident needs

(2) The facility must employ or obtain the services of a licensed pharmacist who

(a) provides consultation on all aspects of pharmacy services in the facility

(b) establishes a system of records of receipt and disposition of all controlled substances which documents an

accurate reconciliation and

(c) determines that drug records are in order and that an account of all controlled substances is maintained and

reconciled monthly_

(3) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist

(a) The pharmacist must report any irregularities to the attending physician and the director of nursing or health

services supervisor

(b) The physician and the director of Nursing or health services supervisor must indicate acceptance or rejection of

the report and document any action taken

(4) Pharmacy personnel must ensure that labels on drugs and biologicals are in accordance with currently accepted professional principles and include the appropriate accessory and cautionary instructions and the expiration date

(5) The facility must store all drugs and biologicals in locked compartments under proper temperature controls according to R432- I 50- I 9 (6)e) and permit only authorized personnel to have access to the keys

Page 3 of 5

Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

(a) The facility must provide separately locked permanently affixed compartments for storage of controlled substances listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse except when the facility uses single unit dose package drug distribution systems in which the

quantity stored is minimal and a missing dose can be readily detected

(b) Non-medication materials that are poisonous or caustic may not be stored with medications

(c) Containers must be clearly labeled

(d) Medication intended for internal use shall be stored separately from medication intended for external use

(e) Medications stored at room temperature shall be maintained within 59 and 80 degrees F

() Refrigerated medications shall be maintained within 36 and 46 degrees F

(6) The facility must maintain an emergency drug supply

(a) Emergency drug containers shall be sealed to prevent unauthorized use

(b) Contents of the emergency drug supply must be listed on the outside of the container and the use of contents shall be documented by the nursing staff

(c) The emergency drug supply shall be stored and located for access by the nursing staff

(d) The pharmacist must inventory the emergency drug supply monthly

(e) Used or outdated items shall be replaced within 72 hours by the pharmacist

(7) The pharmacy must dispense and the facility must ensure that necessary drugs and biologicals are

provided on a timely basis

(8) The facility must limit the duration of a drug order in the absence of tbe prescribers specific

instructions

(9) Drug references must be available for all drugs used in the facility References shall include generic and brand

names available strength and dosage forms indications and side effects and other pharmacological data

(10) Drugs may be sent with the resident upon discharge if so ordered by the discharging physician provided

tbat

(a) such drugs are released in compliance R156-17a-619 and

(b) a record of the drugs sent with the resident is documented in the residents health record

(II) Disposal of controlled substances must be in accordance with the Pharmacy Practice Act

Page 4 of 5

bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull

Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

IMPORTANT POINTS

~ The practice of pharmacy definition and the above described statute prohibit anyone other than a properly licensed pharmacy from possessing stock controlled substances or legend drugs

~The Utah Department of Health has invalid and antiquated administrative rules that supersedes what statute does not allow and existing pharmacy law and rule does not even address some of the operating standards mandated by the pharmacist and pharmacy who are providing pharmacy services

~As the Federal Register states that emergency kits in Long Term Care Facilities are only viewed as compliant with the Controlled Substance Act IF the appropriate state agency or regulatory authority specifically approves such placement anltLQ()lgates procedures which delineate The Utah Department of Health is not the appropriate state agency and moreover the appropriate Utah statute conflicts with the inappropriate state agency administrative rules

~ Additionally the existing administrative rules do not define and cover everything mandated in the Federal Register to even be considered compliant

Page 5 of 6

State of Utah Department of Comnlerce Division of Occupational and Professional Licensing

GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director

GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT

Approved by the Board of Pharmacy May 21 2012

The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include

bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled

substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)

bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and

bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203

NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated

After-hours Medications Taken from Pharmacy When a Pharmacy is Closed

Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours

wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH

Dispensing of Drugs from an Emergency Room

bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount

The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days

bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use

bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD

NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610

Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics

or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution

Federal Statute

According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)

USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but

~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-

dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance

USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration

wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301

LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct

ct 02-05-14 1 56 PM ct

1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Bradley G Last

6

7 LONG TITLE

8 General Description

9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy

10 technicians

11 Highlighted Provisions

12 This bill

13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have

14 access to the database on behalf of the phannacist in accordance with statutory

15 requirements

16 Money Appropriated in this Bill

17 None

18 Other Special Clauses

19 None

20 Utah Code Sections Affected

21 AMENDS

22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262

23

24 Be it enacted by the Legislature ofthe state ofUtah

25

26

27

Section 1 Section 58-37fmiddot301 is amended to read

58-37fmiddot301 Access to database

(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah

rJlbull =bull

1111111111111111111111111111111111111111

02-05-14 156 PM SB178

59 (A) fit within the responsibilities of the Department of Health for health and welfare

60 (B) are reviewed and approved by an Institutional Review Board that is approved for

61 human subject research by the United States Department of Health and Human Services and

62 (C) are not conducted for profit or commercial gain and

63 (D) are conducted in a research facility as defined by division rule that is associated

64 with a university or college in the state accredited by the Northwest Commission on Colleges

65 and Universities

66 (iii) the designee protects the information as a business associate of the Department of

67 Health and

68 (iv) the identity of the prescribers patients and pharmacies in the database are

69 de-identified confidential not disclosed in any manner to the designee or to any individual

70 who is not directly involved in the scientific studies

71 (e) a licensed practitioner having authority to prescribe controlled substances to the

72 extent the information

73 (i) (A) relates specifically to a current or prospective patient of the practitioner and

74 (B) is provided to or sought by the practitioner for the purpose of

75 (I) prescribing or considering prescribing any controlled substance to the current or

76 prospective patient

77 (II) diagnosing the current or prospective patient

78 (nn providing medical treatment or medical advice to the current or prospective

79 patient or

80 (IV) determining whether the current or prospective patient

81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner

82 or

83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled

84 substance from the practitioner

85 (ii) (A) relates specifically to a fonner patient of the practitioner and

86 (B) is provided to or sought by the practitioner for the purpose of determining whether

87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a

88 controlled substance from the practitioner

89 (iii) relates specifically to an individual who has access to the practitioners Drug

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02-05-14 156 PM SB178

121 58-3 7f-203(3 )(b) with respect to the employee

122 (h) a licensed pharmacist having authority to dispense a controlled substance to the

123 extent the information is provided or sought for the purpose of

124 (i) dispensing or considering dispensing any controlled substance or

125 (ii) determining whether a person

126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or

127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled

128 substance from the pharmacist

129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an

]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in

131 Subsection (2)(h)(i) or (iO if

132 0) the employee is designated by the pharmacist-in-charge as an individual authorized

133 to access the information on behalf of a licensed pharmacist employed by the pharmacy

134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of

135 the employee and

136 (iii) the division

137 CA) grants the employee access to the database and

138 (B) provides the employee with a password that is unique to that employee to access

139 the database in order to permit the division to comply with the requirements of Subsection

140 58-37f-203(3)(b) with respect to the employee

141 [fiJ] ill federal state and local law enforcement authorities and state and local

142 prosecutors engaged as a specified duty of their employment in enforcing laws

143 (i) regulating controlled substances

144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or

145 (iii) providing information about a criminal defendant to defense counsel upon request

146 during the discovery process for the purpose of establishing a defense in a criminal case

147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the

148 Department of Health who are engaged in their specified duty of ensuring Medicaid program

149 integrity under Section 26-18-23

150 [fki] ill a mental health therapist if

151 (i) the information relates to a patient who is

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02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

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LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

(a) The facility must provide separately locked permanently affixed compartments for storage of controlled substances listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse except when the facility uses single unit dose package drug distribution systems in which the

quantity stored is minimal and a missing dose can be readily detected

(b) Non-medication materials that are poisonous or caustic may not be stored with medications

(c) Containers must be clearly labeled

(d) Medication intended for internal use shall be stored separately from medication intended for external use

(e) Medications stored at room temperature shall be maintained within 59 and 80 degrees F

() Refrigerated medications shall be maintained within 36 and 46 degrees F

(6) The facility must maintain an emergency drug supply

(a) Emergency drug containers shall be sealed to prevent unauthorized use

(b) Contents of the emergency drug supply must be listed on the outside of the container and the use of contents shall be documented by the nursing staff

(c) The emergency drug supply shall be stored and located for access by the nursing staff

(d) The pharmacist must inventory the emergency drug supply monthly

(e) Used or outdated items shall be replaced within 72 hours by the pharmacist

(7) The pharmacy must dispense and the facility must ensure that necessary drugs and biologicals are

provided on a timely basis

(8) The facility must limit the duration of a drug order in the absence of tbe prescribers specific

instructions

(9) Drug references must be available for all drugs used in the facility References shall include generic and brand

names available strength and dosage forms indications and side effects and other pharmacological data

(10) Drugs may be sent with the resident upon discharge if so ordered by the discharging physician provided

tbat

(a) such drugs are released in compliance R156-17a-619 and

(b) a record of the drugs sent with the resident is documented in the residents health record

(II) Disposal of controlled substances must be in accordance with the Pharmacy Practice Act

Page 4 of 5

bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull

Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

IMPORTANT POINTS

~ The practice of pharmacy definition and the above described statute prohibit anyone other than a properly licensed pharmacy from possessing stock controlled substances or legend drugs

~The Utah Department of Health has invalid and antiquated administrative rules that supersedes what statute does not allow and existing pharmacy law and rule does not even address some of the operating standards mandated by the pharmacist and pharmacy who are providing pharmacy services

~As the Federal Register states that emergency kits in Long Term Care Facilities are only viewed as compliant with the Controlled Substance Act IF the appropriate state agency or regulatory authority specifically approves such placement anltLQ()lgates procedures which delineate The Utah Department of Health is not the appropriate state agency and moreover the appropriate Utah statute conflicts with the inappropriate state agency administrative rules

~ Additionally the existing administrative rules do not define and cover everything mandated in the Federal Register to even be considered compliant

Page 5 of 6

State of Utah Department of Comnlerce Division of Occupational and Professional Licensing

GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director

GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT

Approved by the Board of Pharmacy May 21 2012

The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include

bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled

substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)

bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and

bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203

NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated

After-hours Medications Taken from Pharmacy When a Pharmacy is Closed

Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours

wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH

Dispensing of Drugs from an Emergency Room

bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount

The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days

bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use

bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD

NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610

Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics

or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution

Federal Statute

According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)

USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but

~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-

dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance

USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration

wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301

LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct

ct 02-05-14 1 56 PM ct

1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Bradley G Last

6

7 LONG TITLE

8 General Description

9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy

10 technicians

11 Highlighted Provisions

12 This bill

13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have

14 access to the database on behalf of the phannacist in accordance with statutory

15 requirements

16 Money Appropriated in this Bill

17 None

18 Other Special Clauses

19 None

20 Utah Code Sections Affected

21 AMENDS

22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262

23

24 Be it enacted by the Legislature ofthe state ofUtah

25

26

27

Section 1 Section 58-37fmiddot301 is amended to read

58-37fmiddot301 Access to database

(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah

rJlbull =bull

1111111111111111111111111111111111111111

02-05-14 156 PM SB178

59 (A) fit within the responsibilities of the Department of Health for health and welfare

60 (B) are reviewed and approved by an Institutional Review Board that is approved for

61 human subject research by the United States Department of Health and Human Services and

62 (C) are not conducted for profit or commercial gain and

63 (D) are conducted in a research facility as defined by division rule that is associated

64 with a university or college in the state accredited by the Northwest Commission on Colleges

65 and Universities

66 (iii) the designee protects the information as a business associate of the Department of

67 Health and

68 (iv) the identity of the prescribers patients and pharmacies in the database are

69 de-identified confidential not disclosed in any manner to the designee or to any individual

70 who is not directly involved in the scientific studies

71 (e) a licensed practitioner having authority to prescribe controlled substances to the

72 extent the information

73 (i) (A) relates specifically to a current or prospective patient of the practitioner and

74 (B) is provided to or sought by the practitioner for the purpose of

75 (I) prescribing or considering prescribing any controlled substance to the current or

76 prospective patient

77 (II) diagnosing the current or prospective patient

78 (nn providing medical treatment or medical advice to the current or prospective

79 patient or

80 (IV) determining whether the current or prospective patient

81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner

82 or

83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled

84 substance from the practitioner

85 (ii) (A) relates specifically to a fonner patient of the practitioner and

86 (B) is provided to or sought by the practitioner for the purpose of determining whether

87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a

88 controlled substance from the practitioner

89 (iii) relates specifically to an individual who has access to the practitioners Drug

- 3 shy

02-05-14 156 PM SB178

121 58-3 7f-203(3 )(b) with respect to the employee

122 (h) a licensed pharmacist having authority to dispense a controlled substance to the

123 extent the information is provided or sought for the purpose of

124 (i) dispensing or considering dispensing any controlled substance or

125 (ii) determining whether a person

126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or

127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled

128 substance from the pharmacist

129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an

]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in

131 Subsection (2)(h)(i) or (iO if

132 0) the employee is designated by the pharmacist-in-charge as an individual authorized

133 to access the information on behalf of a licensed pharmacist employed by the pharmacy

134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of

135 the employee and

136 (iii) the division

137 CA) grants the employee access to the database and

138 (B) provides the employee with a password that is unique to that employee to access

139 the database in order to permit the division to comply with the requirements of Subsection

140 58-37f-203(3)(b) with respect to the employee

141 [fiJ] ill federal state and local law enforcement authorities and state and local

142 prosecutors engaged as a specified duty of their employment in enforcing laws

143 (i) regulating controlled substances

144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or

145 (iii) providing information about a criminal defendant to defense counsel upon request

146 during the discovery process for the purpose of establishing a defense in a criminal case

147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the

148 Department of Health who are engaged in their specified duty of ensuring Medicaid program

149 integrity under Section 26-18-23

150 [fki] ill a mental health therapist if

151 (i) the information relates to a patient who is

- 5 shy

02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

- 7

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull

Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott

IMPORTANT POINTS

~ The practice of pharmacy definition and the above described statute prohibit anyone other than a properly licensed pharmacy from possessing stock controlled substances or legend drugs

~The Utah Department of Health has invalid and antiquated administrative rules that supersedes what statute does not allow and existing pharmacy law and rule does not even address some of the operating standards mandated by the pharmacist and pharmacy who are providing pharmacy services

~As the Federal Register states that emergency kits in Long Term Care Facilities are only viewed as compliant with the Controlled Substance Act IF the appropriate state agency or regulatory authority specifically approves such placement anltLQ()lgates procedures which delineate The Utah Department of Health is not the appropriate state agency and moreover the appropriate Utah statute conflicts with the inappropriate state agency administrative rules

~ Additionally the existing administrative rules do not define and cover everything mandated in the Federal Register to even be considered compliant

Page 5 of 6

State of Utah Department of Comnlerce Division of Occupational and Professional Licensing

GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director

GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT

Approved by the Board of Pharmacy May 21 2012

The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include

bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled

substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)

bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and

bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203

NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated

After-hours Medications Taken from Pharmacy When a Pharmacy is Closed

Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours

wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH

Dispensing of Drugs from an Emergency Room

bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount

The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days

bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use

bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD

NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610

Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics

or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution

Federal Statute

According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)

USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but

~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-

dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance

USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration

wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301

LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct

ct 02-05-14 1 56 PM ct

1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Bradley G Last

6

7 LONG TITLE

8 General Description

9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy

10 technicians

11 Highlighted Provisions

12 This bill

13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have

14 access to the database on behalf of the phannacist in accordance with statutory

15 requirements

16 Money Appropriated in this Bill

17 None

18 Other Special Clauses

19 None

20 Utah Code Sections Affected

21 AMENDS

22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262

23

24 Be it enacted by the Legislature ofthe state ofUtah

25

26

27

Section 1 Section 58-37fmiddot301 is amended to read

58-37fmiddot301 Access to database

(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah

rJlbull =bull

1111111111111111111111111111111111111111

02-05-14 156 PM SB178

59 (A) fit within the responsibilities of the Department of Health for health and welfare

60 (B) are reviewed and approved by an Institutional Review Board that is approved for

61 human subject research by the United States Department of Health and Human Services and

62 (C) are not conducted for profit or commercial gain and

63 (D) are conducted in a research facility as defined by division rule that is associated

64 with a university or college in the state accredited by the Northwest Commission on Colleges

65 and Universities

66 (iii) the designee protects the information as a business associate of the Department of

67 Health and

68 (iv) the identity of the prescribers patients and pharmacies in the database are

69 de-identified confidential not disclosed in any manner to the designee or to any individual

70 who is not directly involved in the scientific studies

71 (e) a licensed practitioner having authority to prescribe controlled substances to the

72 extent the information

73 (i) (A) relates specifically to a current or prospective patient of the practitioner and

74 (B) is provided to or sought by the practitioner for the purpose of

75 (I) prescribing or considering prescribing any controlled substance to the current or

76 prospective patient

77 (II) diagnosing the current or prospective patient

78 (nn providing medical treatment or medical advice to the current or prospective

79 patient or

80 (IV) determining whether the current or prospective patient

81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner

82 or

83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled

84 substance from the practitioner

85 (ii) (A) relates specifically to a fonner patient of the practitioner and

86 (B) is provided to or sought by the practitioner for the purpose of determining whether

87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a

88 controlled substance from the practitioner

89 (iii) relates specifically to an individual who has access to the practitioners Drug

- 3 shy

02-05-14 156 PM SB178

121 58-3 7f-203(3 )(b) with respect to the employee

122 (h) a licensed pharmacist having authority to dispense a controlled substance to the

123 extent the information is provided or sought for the purpose of

124 (i) dispensing or considering dispensing any controlled substance or

125 (ii) determining whether a person

126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or

127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled

128 substance from the pharmacist

129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an

]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in

131 Subsection (2)(h)(i) or (iO if

132 0) the employee is designated by the pharmacist-in-charge as an individual authorized

133 to access the information on behalf of a licensed pharmacist employed by the pharmacy

134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of

135 the employee and

136 (iii) the division

137 CA) grants the employee access to the database and

138 (B) provides the employee with a password that is unique to that employee to access

139 the database in order to permit the division to comply with the requirements of Subsection

140 58-37f-203(3)(b) with respect to the employee

141 [fiJ] ill federal state and local law enforcement authorities and state and local

142 prosecutors engaged as a specified duty of their employment in enforcing laws

143 (i) regulating controlled substances

144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or

145 (iii) providing information about a criminal defendant to defense counsel upon request

146 during the discovery process for the purpose of establishing a defense in a criminal case

147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the

148 Department of Health who are engaged in their specified duty of ensuring Medicaid program

149 integrity under Section 26-18-23

150 [fki] ill a mental health therapist if

151 (i) the information relates to a patient who is

- 5 shy

02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

- 7

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

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SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

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LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

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02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

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02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

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LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

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HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

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02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

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State of Utah Department of Comnlerce Division of Occupational and Professional Licensing

GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director

GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT

Approved by the Board of Pharmacy May 21 2012

The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include

bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled

substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)

bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and

bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203

NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated

After-hours Medications Taken from Pharmacy When a Pharmacy is Closed

Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours

wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH

Dispensing of Drugs from an Emergency Room

bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount

The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days

bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use

bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD

NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610

Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics

or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution

Federal Statute

According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)

USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but

~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-

dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance

USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration

wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301

LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct

ct 02-05-14 1 56 PM ct

1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Bradley G Last

6

7 LONG TITLE

8 General Description

9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy

10 technicians

11 Highlighted Provisions

12 This bill

13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have

14 access to the database on behalf of the phannacist in accordance with statutory

15 requirements

16 Money Appropriated in this Bill

17 None

18 Other Special Clauses

19 None

20 Utah Code Sections Affected

21 AMENDS

22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262

23

24 Be it enacted by the Legislature ofthe state ofUtah

25

26

27

Section 1 Section 58-37fmiddot301 is amended to read

58-37fmiddot301 Access to database

(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah

rJlbull =bull

1111111111111111111111111111111111111111

02-05-14 156 PM SB178

59 (A) fit within the responsibilities of the Department of Health for health and welfare

60 (B) are reviewed and approved by an Institutional Review Board that is approved for

61 human subject research by the United States Department of Health and Human Services and

62 (C) are not conducted for profit or commercial gain and

63 (D) are conducted in a research facility as defined by division rule that is associated

64 with a university or college in the state accredited by the Northwest Commission on Colleges

65 and Universities

66 (iii) the designee protects the information as a business associate of the Department of

67 Health and

68 (iv) the identity of the prescribers patients and pharmacies in the database are

69 de-identified confidential not disclosed in any manner to the designee or to any individual

70 who is not directly involved in the scientific studies

71 (e) a licensed practitioner having authority to prescribe controlled substances to the

72 extent the information

73 (i) (A) relates specifically to a current or prospective patient of the practitioner and

74 (B) is provided to or sought by the practitioner for the purpose of

75 (I) prescribing or considering prescribing any controlled substance to the current or

76 prospective patient

77 (II) diagnosing the current or prospective patient

78 (nn providing medical treatment or medical advice to the current or prospective

79 patient or

80 (IV) determining whether the current or prospective patient

81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner

82 or

83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled

84 substance from the practitioner

85 (ii) (A) relates specifically to a fonner patient of the practitioner and

86 (B) is provided to or sought by the practitioner for the purpose of determining whether

87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a

88 controlled substance from the practitioner

89 (iii) relates specifically to an individual who has access to the practitioners Drug

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02-05-14 156 PM SB178

121 58-3 7f-203(3 )(b) with respect to the employee

122 (h) a licensed pharmacist having authority to dispense a controlled substance to the

123 extent the information is provided or sought for the purpose of

124 (i) dispensing or considering dispensing any controlled substance or

125 (ii) determining whether a person

126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or

127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled

128 substance from the pharmacist

129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an

]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in

131 Subsection (2)(h)(i) or (iO if

132 0) the employee is designated by the pharmacist-in-charge as an individual authorized

133 to access the information on behalf of a licensed pharmacist employed by the pharmacy

134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of

135 the employee and

136 (iii) the division

137 CA) grants the employee access to the database and

138 (B) provides the employee with a password that is unique to that employee to access

139 the database in order to permit the division to comply with the requirements of Subsection

140 58-37f-203(3)(b) with respect to the employee

141 [fiJ] ill federal state and local law enforcement authorities and state and local

142 prosecutors engaged as a specified duty of their employment in enforcing laws

143 (i) regulating controlled substances

144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or

145 (iii) providing information about a criminal defendant to defense counsel upon request

146 during the discovery process for the purpose of establishing a defense in a criminal case

147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the

148 Department of Health who are engaged in their specified duty of ensuring Medicaid program

149 integrity under Section 26-18-23

150 [fki] ill a mental health therapist if

151 (i) the information relates to a patient who is

- 5 shy

02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

- 7

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

Dispensing of Drugs from an Emergency Room

bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount

The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days

bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use

bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD

NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610

Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics

or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution

Federal Statute

According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)

USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but

~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-

dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance

USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration

wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301

LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct

ct 02-05-14 1 56 PM ct

1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Bradley G Last

6

7 LONG TITLE

8 General Description

9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy

10 technicians

11 Highlighted Provisions

12 This bill

13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have

14 access to the database on behalf of the phannacist in accordance with statutory

15 requirements

16 Money Appropriated in this Bill

17 None

18 Other Special Clauses

19 None

20 Utah Code Sections Affected

21 AMENDS

22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262

23

24 Be it enacted by the Legislature ofthe state ofUtah

25

26

27

Section 1 Section 58-37fmiddot301 is amended to read

58-37fmiddot301 Access to database

(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah

rJlbull =bull

1111111111111111111111111111111111111111

02-05-14 156 PM SB178

59 (A) fit within the responsibilities of the Department of Health for health and welfare

60 (B) are reviewed and approved by an Institutional Review Board that is approved for

61 human subject research by the United States Department of Health and Human Services and

62 (C) are not conducted for profit or commercial gain and

63 (D) are conducted in a research facility as defined by division rule that is associated

64 with a university or college in the state accredited by the Northwest Commission on Colleges

65 and Universities

66 (iii) the designee protects the information as a business associate of the Department of

67 Health and

68 (iv) the identity of the prescribers patients and pharmacies in the database are

69 de-identified confidential not disclosed in any manner to the designee or to any individual

70 who is not directly involved in the scientific studies

71 (e) a licensed practitioner having authority to prescribe controlled substances to the

72 extent the information

73 (i) (A) relates specifically to a current or prospective patient of the practitioner and

74 (B) is provided to or sought by the practitioner for the purpose of

75 (I) prescribing or considering prescribing any controlled substance to the current or

76 prospective patient

77 (II) diagnosing the current or prospective patient

78 (nn providing medical treatment or medical advice to the current or prospective

79 patient or

80 (IV) determining whether the current or prospective patient

81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner

82 or

83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled

84 substance from the practitioner

85 (ii) (A) relates specifically to a fonner patient of the practitioner and

86 (B) is provided to or sought by the practitioner for the purpose of determining whether

87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a

88 controlled substance from the practitioner

89 (iii) relates specifically to an individual who has access to the practitioners Drug

- 3 shy

02-05-14 156 PM SB178

121 58-3 7f-203(3 )(b) with respect to the employee

122 (h) a licensed pharmacist having authority to dispense a controlled substance to the

123 extent the information is provided or sought for the purpose of

124 (i) dispensing or considering dispensing any controlled substance or

125 (ii) determining whether a person

126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or

127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled

128 substance from the pharmacist

129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an

]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in

131 Subsection (2)(h)(i) or (iO if

132 0) the employee is designated by the pharmacist-in-charge as an individual authorized

133 to access the information on behalf of a licensed pharmacist employed by the pharmacy

134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of

135 the employee and

136 (iii) the division

137 CA) grants the employee access to the database and

138 (B) provides the employee with a password that is unique to that employee to access

139 the database in order to permit the division to comply with the requirements of Subsection

140 58-37f-203(3)(b) with respect to the employee

141 [fiJ] ill federal state and local law enforcement authorities and state and local

142 prosecutors engaged as a specified duty of their employment in enforcing laws

143 (i) regulating controlled substances

144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or

145 (iii) providing information about a criminal defendant to defense counsel upon request

146 during the discovery process for the purpose of establishing a defense in a criminal case

147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the

148 Department of Health who are engaged in their specified duty of ensuring Medicaid program

149 integrity under Section 26-18-23

150 [fki] ill a mental health therapist if

151 (i) the information relates to a patient who is

- 5 shy

02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

- 7

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct

ct 02-05-14 1 56 PM ct

1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Bradley G Last

6

7 LONG TITLE

8 General Description

9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy

10 technicians

11 Highlighted Provisions

12 This bill

13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have

14 access to the database on behalf of the phannacist in accordance with statutory

15 requirements

16 Money Appropriated in this Bill

17 None

18 Other Special Clauses

19 None

20 Utah Code Sections Affected

21 AMENDS

22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262

23

24 Be it enacted by the Legislature ofthe state ofUtah

25

26

27

Section 1 Section 58-37fmiddot301 is amended to read

58-37fmiddot301 Access to database

(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah

rJlbull =bull

1111111111111111111111111111111111111111

02-05-14 156 PM SB178

59 (A) fit within the responsibilities of the Department of Health for health and welfare

60 (B) are reviewed and approved by an Institutional Review Board that is approved for

61 human subject research by the United States Department of Health and Human Services and

62 (C) are not conducted for profit or commercial gain and

63 (D) are conducted in a research facility as defined by division rule that is associated

64 with a university or college in the state accredited by the Northwest Commission on Colleges

65 and Universities

66 (iii) the designee protects the information as a business associate of the Department of

67 Health and

68 (iv) the identity of the prescribers patients and pharmacies in the database are

69 de-identified confidential not disclosed in any manner to the designee or to any individual

70 who is not directly involved in the scientific studies

71 (e) a licensed practitioner having authority to prescribe controlled substances to the

72 extent the information

73 (i) (A) relates specifically to a current or prospective patient of the practitioner and

74 (B) is provided to or sought by the practitioner for the purpose of

75 (I) prescribing or considering prescribing any controlled substance to the current or

76 prospective patient

77 (II) diagnosing the current or prospective patient

78 (nn providing medical treatment or medical advice to the current or prospective

79 patient or

80 (IV) determining whether the current or prospective patient

81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner

82 or

83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled

84 substance from the practitioner

85 (ii) (A) relates specifically to a fonner patient of the practitioner and

86 (B) is provided to or sought by the practitioner for the purpose of determining whether

87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a

88 controlled substance from the practitioner

89 (iii) relates specifically to an individual who has access to the practitioners Drug

- 3 shy

02-05-14 156 PM SB178

121 58-3 7f-203(3 )(b) with respect to the employee

122 (h) a licensed pharmacist having authority to dispense a controlled substance to the

123 extent the information is provided or sought for the purpose of

124 (i) dispensing or considering dispensing any controlled substance or

125 (ii) determining whether a person

126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or

127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled

128 substance from the pharmacist

129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an

]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in

131 Subsection (2)(h)(i) or (iO if

132 0) the employee is designated by the pharmacist-in-charge as an individual authorized

133 to access the information on behalf of a licensed pharmacist employed by the pharmacy

134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of

135 the employee and

136 (iii) the division

137 CA) grants the employee access to the database and

138 (B) provides the employee with a password that is unique to that employee to access

139 the database in order to permit the division to comply with the requirements of Subsection

140 58-37f-203(3)(b) with respect to the employee

141 [fiJ] ill federal state and local law enforcement authorities and state and local

142 prosecutors engaged as a specified duty of their employment in enforcing laws

143 (i) regulating controlled substances

144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or

145 (iii) providing information about a criminal defendant to defense counsel upon request

146 during the discovery process for the purpose of establishing a defense in a criminal case

147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the

148 Department of Health who are engaged in their specified duty of ensuring Medicaid program

149 integrity under Section 26-18-23

150 [fki] ill a mental health therapist if

151 (i) the information relates to a patient who is

- 5 shy

02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

- 7

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

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02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

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02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

02-05-14 156 PM SB178

59 (A) fit within the responsibilities of the Department of Health for health and welfare

60 (B) are reviewed and approved by an Institutional Review Board that is approved for

61 human subject research by the United States Department of Health and Human Services and

62 (C) are not conducted for profit or commercial gain and

63 (D) are conducted in a research facility as defined by division rule that is associated

64 with a university or college in the state accredited by the Northwest Commission on Colleges

65 and Universities

66 (iii) the designee protects the information as a business associate of the Department of

67 Health and

68 (iv) the identity of the prescribers patients and pharmacies in the database are

69 de-identified confidential not disclosed in any manner to the designee or to any individual

70 who is not directly involved in the scientific studies

71 (e) a licensed practitioner having authority to prescribe controlled substances to the

72 extent the information

73 (i) (A) relates specifically to a current or prospective patient of the practitioner and

74 (B) is provided to or sought by the practitioner for the purpose of

75 (I) prescribing or considering prescribing any controlled substance to the current or

76 prospective patient

77 (II) diagnosing the current or prospective patient

78 (nn providing medical treatment or medical advice to the current or prospective

79 patient or

80 (IV) determining whether the current or prospective patient

81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner

82 or

83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled

84 substance from the practitioner

85 (ii) (A) relates specifically to a fonner patient of the practitioner and

86 (B) is provided to or sought by the practitioner for the purpose of determining whether

87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a

88 controlled substance from the practitioner

89 (iii) relates specifically to an individual who has access to the practitioners Drug

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02-05-14 156 PM SB178

121 58-3 7f-203(3 )(b) with respect to the employee

122 (h) a licensed pharmacist having authority to dispense a controlled substance to the

123 extent the information is provided or sought for the purpose of

124 (i) dispensing or considering dispensing any controlled substance or

125 (ii) determining whether a person

126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or

127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled

128 substance from the pharmacist

129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an

]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in

131 Subsection (2)(h)(i) or (iO if

132 0) the employee is designated by the pharmacist-in-charge as an individual authorized

133 to access the information on behalf of a licensed pharmacist employed by the pharmacy

134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of

135 the employee and

136 (iii) the division

137 CA) grants the employee access to the database and

138 (B) provides the employee with a password that is unique to that employee to access

139 the database in order to permit the division to comply with the requirements of Subsection

140 58-37f-203(3)(b) with respect to the employee

141 [fiJ] ill federal state and local law enforcement authorities and state and local

142 prosecutors engaged as a specified duty of their employment in enforcing laws

143 (i) regulating controlled substances

144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or

145 (iii) providing information about a criminal defendant to defense counsel upon request

146 during the discovery process for the purpose of establishing a defense in a criminal case

147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the

148 Department of Health who are engaged in their specified duty of ensuring Medicaid program

149 integrity under Section 26-18-23

150 [fki] ill a mental health therapist if

151 (i) the information relates to a patient who is

- 5 shy

02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

- 7

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

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02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

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02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

02-05-14 156 PM SB178

121 58-3 7f-203(3 )(b) with respect to the employee

122 (h) a licensed pharmacist having authority to dispense a controlled substance to the

123 extent the information is provided or sought for the purpose of

124 (i) dispensing or considering dispensing any controlled substance or

125 (ii) determining whether a person

126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or

127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled

128 substance from the pharmacist

129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an

]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in

131 Subsection (2)(h)(i) or (iO if

132 0) the employee is designated by the pharmacist-in-charge as an individual authorized

133 to access the information on behalf of a licensed pharmacist employed by the pharmacy

134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of

135 the employee and

136 (iii) the division

137 CA) grants the employee access to the database and

138 (B) provides the employee with a password that is unique to that employee to access

139 the database in order to permit the division to comply with the requirements of Subsection

140 58-37f-203(3)(b) with respect to the employee

141 [fiJ] ill federal state and local law enforcement authorities and state and local

142 prosecutors engaged as a specified duty of their employment in enforcing laws

143 (i) regulating controlled substances

144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or

145 (iii) providing information about a criminal defendant to defense counsel upon request

146 during the discovery process for the purpose of establishing a defense in a criminal case

147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the

148 Department of Health who are engaged in their specified duty of ensuring Medicaid program

149 integrity under Section 26-18-23

150 [fki] ill a mental health therapist if

151 (i) the information relates to a patient who is

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02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

- 7

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

02-05-14 156 PM SB178

183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database

184 and

185 (ii) establish the information to be provided by an emergency room employee under

186 Subsection (4)

187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or

188 (4)( c) access to the database unless the division determines based on a background check that

189 the employee poses a security risk to the information contained in the database

190 (4) (a) An individual who is employed in the emergency room ofa hospital may

191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if

192 the individual is designated under Subsection (4)( c) and the licensed practitioner

193 (i) is employed in the emergency room

194 Oi) is treating an emergency room patient for an emergency medical condition and

195 (iii) requests that an individual employed in the emergency room and designated under

196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the

197 course of treatment

198 (b) The emergency room employee obtaining information from the database shall

199 when gaining access to the database provide to the database the name and any additional

200 identifiers regarding the requesting practitioner as required by division administrative rule

201 established under Subsection (3)(b)

202 (c) An individual employed in the emergency room under this Subsection (4) may

203 obtain information from the database as provided in Subsection (4)(a) if

204 (i) the employee is designated by the practitioner as an individual authorized to access

205 the information on behalf of the practitioner

206 (ii) the practitioner and the hospital operating the emergency room provide written

207 notice to the division of the identity of the designated employee and

208 (iii) the division

209 (A) grants the employee access to the database and

210 (B) provides the employee with a password that is unique to that employee to access

211 the database in order to permit the division to comply with the requirements of Subsection

212 58-37f-203(3)(b) with respect to the employee

213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a

- 7

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)

iL 02-07-14 416 PM iL

Senator Evan J Vickers proposes the following substitute bill

PHARMACEUTICAL DISPENSING AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner

10 license and a license classification for a dispensing medical practitioner clinic

11 pharmacy

12 Highlighted Provisions

13 This bill

14 defines terms

15 establishes the license classification dispensing medical practitioner under the

16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug

17 establishes the pharmacy facility license classification dispensing medical

18 practitioner clinic pharmacy under the Pharmacy Practice Act

19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner

20 Clinic Pharmacy

21 removes the exemption from the Pharmacy Practice Act for medical practitioners

22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer

23 drug treatment regimen

24 requires a license as a dispensing medical practitioner for a health care practitioner 00

25 to dispense bull bull=

1111111111111111111111111111111111111111111111111111111

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

02-07-14 416 PM 1st Sub (Green) SB 55

615 Practitioner Clinic Pharmacy II

616 Section 8 Section 58-17b-802 is enacted to read

617 58-17b-802 Definitions

618 As used in this part

619 (1) (a) Cosmetic drug means a prescription drug that

620 (i) is for the purpose of promoting attractiveness or altering the appearance of an

621 individual and

622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the

623 division by administrative rule or

624 CB) has been expressly approved for online dispensing whether or not it is dispensed

625 online or through a physicians office

626 (b) Cosmetic drug does not include a prescription drug that is

627 (i) a controlled substance

628 (ii) compounded by the physician or

629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or

630 preventing a disease

631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is

631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the

632 employees of an exclusive group of employers and the employees dependents

633 (3) Health care is as defined in Section 31A-1-301

634 (4) Ca) Injectable weight loss drug means an injectable prescription drug

635 (n prescribed to promote weight loss and

636 (ii) listed as an injectable prescription drug subject to exemption under this section by

637 the division by administrative rule

638 (b) Injectable weight loss drug does not include a prescription drug that is a

639 controlled substance

640 (5) Prepackaged drug means a prescription drug that

641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and

642 (b) is packaged in a fixed quantity per package by

643 (i) the drug manufacturer

644 (ii) a pharmaceutical wholesaler or distributor or

645 (iii) a pharmacy licensed under this title

- 21 Senate Committee Amendments 2-13-2014 Jplcjd

1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

- 22 - Senate Committee Amendments 2-13-2014 picjd

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

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SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

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LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

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02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

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02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

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LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

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HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

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02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

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1st Sub (Green) SB 55 02-07-14 416 PM

646 Section 9 Section 58-17b-803 is enacted to read

647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy

648 Scope of practice

649 (1) An applicant for a license as a dispensing medical practitioner shall

650 (a) be licensed in good standing under at least one of the chapters listed in Subsection

651 58-17b-l02(23)(a) and

652 (b) submit an application for a license as a dispensing medical practitioner in a form

653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~

654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu

655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and

656

657 (3) A dispensing medical practitioner may dispense in accordance with this part

658 (a) a cosmetic drug and an injectable weight loss drug if

659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing

660 medical practitioners patient and

661 Oi) the dispensing medical practitioner complies with administrative rules adopted by

662 the division under Subsection 58-17-802(1)

663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies

664 with Section 58-17b-805 and

665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer

666 sponsored clinic if the dispensing medical practitioner

667 (i) treats an employee or the dependent of an employee of one of an exclusive group

668 of employers at an employer sponsored clinic

669 (ii) prescribes a prepackaged drug to the employee or the employees dependent

670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and

671 (iv) complies with administrative rules adopted by the division in consultation with the

672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and

673 distribution operating treatment quality of care and storage requirements

674 (4) A dispensing medical practitioner

675 Ca) shall inform the patient

676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy

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02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

02-07-14 416 PM 1st Sub (Green) SB 55

739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner

740 clinic pharmacy -- Unprofessional and Unlawful conduct

741 ill S Ull S The division S [ iii consultation witb tile boal d shall

742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult

742a with S the

743 dispensing medical practitioners appropriate licensing board as designated in Subsection

744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and

745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine

745a medical practitionerS assist the licensing board for the dispensing medical practitioner with

745b reviewing the

746 violations of the provisions of this chapter

747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take

747a appropriate

748 action against a dispensing medical practitioner in accordance with this chapter if the

749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that

750 action be taken under this chapter

751 (3) The division in consultation with the board is the primary enforcer under this

752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section

753 58-17b-804

754 Section 13 Section 58-31b-502 is amended to read

755 58-31b-502 Unprofessional conduct

756 Unprofessional conduct includes

757 (l) failure to safeguard a patients right to privacy as to the patients person condition

758 diagnosis personal effects or any other matter about which the licensee is privileged to know

759 because of the licensees or person with a certifications position or practice as a nurse or

760 practice as a medication aide certified

761 (2) failure to provide nursing service or service as a medication aide certified in a

762 manner that demonstrates respect for the patients human dignity and unique personal character

763 and needs without regard to the patients race religion ethnic background socioeconomic

764 status age sex or the nature of the patients health problem

765 (3) engaging in sexual relations with a patient during any

766 (a) period when a generally recognized professional relationship exists between the

767 person licensed or certified under this chapter and patient or

768 (b) extended period when a patient has reasonable cause to believe a professional

769 relationship exists between the person licensed or certified under the provisions of this chapter

- 25 - Senate Committee Amendments 2-13-2014Iplcjd

LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

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LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct

ct 02-04-14 1220 PM ct

1 CONTROLLED SUBSTANCES ACT AMENDMENTS

2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Evan J Vickers

5 House Sponsor Stewart Barlow

6

7 LONG TITLE

8 General Description

9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for

10 controlled substances

11 Highlighted Provisions

12 This bill

13 ~ provides that more than one controlled substance may be included in a prescription

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 None

18 Utah Code Sections Affected

19 AMENDS

20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272

21

22 Be it enacted by the Legislature of the state ofUtah

23 Section 1 Section 58-37-6 is amended to read

24 58-37-6 License to manufacture produce distribute dispense administer or

25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records

26

27

required -- Prescriptions

(1) (a) The division may adopt rules relating to the licensing and control of the bull

1111111111111111111111111111111111111111

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

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LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

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02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

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02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

SB138 02-04-14 1220 PM

214 (ii) the prescribed controlled substance is to be used in research

215 (f) Except when administered directly to an ultimate user by a licensed practitioner

216 controlled substances are subject to the following restrictions

217 (i) (A) A prescription for a Schedule IT substance may not be refilled

218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a

219 one-months supply as directed on the daily dosage rate of the prescriptions

220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of

221 issuance and may not be refilled more than six months after the date of its original issuance or

222 be refilled more than five times after the date of the prescription unless renewed by the

223 practitioner

224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers

225 prescription directs but they may not be refilled one year after the date the prescription was

226 issued unless renewed by the practitioner

227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not

228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days

229 after the date the prescription was issued or 30 days after the dispensing date if that date is

230 specified separately from the date of issue

231 (v) A practitioner may issue more than one prescription at the same time for the same

232 Schedule IT controlled substance but only under the following conditions

233 (A) no more than three prescriptions for the same Schedule IT controlled substance may

234 be issued at the same time

235 (B) no one prescription may exceed a 30-day supply

236 (C) a second or third prescription shall include the date of issuance and the date for

237 dispensing and

238 (D) unless the practitioner determines there is a valid medical reason to the contrary

239 the date for dispensing a second or third prescription may not be fewer than 30 days from the

240 dispensing date of the previous prescription

241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled

242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription

243 item]

244 (g) An order for a controlled substance in Schedules IT through V for use by an

- 8 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

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02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it

HB114

it 02-06-14855 AM it

1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION

3 STATE OF UTAH

4 Chief Sponsor Stewart Barlow

5 Senate Sponsor ______

6

7 LONG TITLE

8 General Description

9 This bill amends the Pharmacy Practice Act

10 Highlighted Provisions

11 This bill

12 ~ amends the definition of a class C pharmacy subject to regulation under the

13 Pharmacy Practice Act

14 Money Appropriated in this Bill

15 None

16 Other Special Clauses

17 This bi II takes effect on July 1 2014

18 Utah Code Sections Affected

19 AMENDS

20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423

21

22 Be it enacted by the Legislature ofthe state ofUtah

23 Section 1 Section 58-17b-102 is amended to read

24 58-17b-102 Definitions

25 In addition to the definitions in Section 58-1-102 as used in this chapter

26

27

(1) Administering means

(a) the direct application of a prescription drug or device whether by injection

==bull =bull

1111111111111111111111111111111111111111

02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

- 3 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

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02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

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02-06-14855 AM HB114

59 (9) Centralized prescription processing means the processing by a pharmacy of a

60 request from another pharmacy to fill or refill a prescription drug order or to perform

61 processing functions such as dispensing drug utilization review claims adjudication refill

62 authorizations and therapeutic interventions

63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a

64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a

65 prescription order

66 (11) Class B pharmacy

67 (a) means a pharmacy located in Utah

68 (i) that is authorized to provide pharmaceutical care for patients in an institutional

69 setting and

70 (ii) whose primary purpose is to provide a physical environment for patients to obtain

71 health care services and

72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and

73 (ii) pharmaceutical administration and sterile product preparation facilities

74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to

75 engage] that engages in the manufacture production wholesale or distribution of drugs or

76 devices in Utah

77 (13) Class D pharmacy means a nonresident pharmacy

78 (14) Class E pharmacy means all other pharmacies

79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a

80 defined and exclusive group of patients who have access to the services of the pharmacy

81 because they are treated by or have an affiliation with a specific entity including a health

82 maintenance organization or an infusion company but not including a hospital pharmacy a

83 retailer of goods to the general public or the office of a practitioner

84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or

85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or

86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical

87 care functions authorized by the practitioner or practitioners under certain specified conditions

88 or limitations

89 (17) Collaborative pharmacy practice agreement means a written and signed

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02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

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LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

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02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

02-06-14855 AM HB114

369 and

370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

371 collaboration with the board

372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501

373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and

374 may be further defined by rule

375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that

376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration

377 for animals

378 Section 2 Effective date

379 This bill takes effect on July I 2014

Legislative Review Note as of 2-4-14 1243 PM

Office of Legislative Research and General Counsel

- 13 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t

t 02-05-14 122PM t

1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG

2 AMENDMENTS

3 2014 GENERAL SESSION

4 STATE OF UTAH

5 Chief Sponsor Stewart Barlow

6 Senate Sponsor

7

8 LONG TITLE

9 General Description

10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from

11 its licensing requirements under certain circumstances

12 Highlighted Provisions

13 This bill

14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy

15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an

16 employer sponsored clinic and complies with other requirements

17 repeals subject to sunset review the provisions of this bill relating to the exemption

18 described above and

19 ~ makes technical and conforming changes

20 Money Appropriated in this Bill

21 None

22 Other Special Clauses

23 None

24 Utah Code Sections Affected

25 AMENDS

26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~

27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull

1111111111111111111111111111111111111111

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

-2shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

- 3 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

-4shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

HBI06 02-05-14 122 PM

28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278

29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234

30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351

31 ENACTS

32 58-17b-3097 Utah Code Annotated 1953

33

34 Be it enacted by the Legislature ofthe state ofUtah

35 Section 1 Section 58-17b-301 is amended to read

36 58-17b-301 License required -- License classifications for individuals

37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the

38 practice of a pharmacy technician except as specifically provided in Section 58-1-307

39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097

40 (2) The division shall issue to an individual who qualifies under this chapter a license

41 in the classification of

42 (a) pharmacist

43 (b) pharmacy intern or

44 (c) pharmacy technician

45 Section 2 Section 58-17b-302 is amended to read

46 58-17b-302 License required -- License classifications for pharmacy facilities

47 (l) A license is required to act as a pharmacy except as specifically exempted from

48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or

49

50 (2) The division shall issue a pharmacy license to a facility that qualifies under this

51 chapter in the classification of a

52 (a) class A pharmacy

53 (b) class B pharmacy

54 (c) class C pharmacy

55 (d) class D pharmacy or

56 (e) class E pharmacy

57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist

58 at the same address a separate license shall be required for each pharmacy

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02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

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HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

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02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

02-05-14 122 PM HBI06

59 (4) The division may further define or supplement the classifications of pharmacies

60 The division may impose restrictions upon classifications to protect the public health safety

61 and welfare

62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by

63 rule

64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy

65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities

66 of the pharmacy regardless of the form of the business organization

67 Section 3 Section 58-17b-309 is amended to read

68 58-17b-309 Exemptions from licensure

69 (l) [For ptnp05C5 of] As used in this section

70 (a) Cosmetic drug

71 (i) means a prescription drug that is

72 (A) for the purpose of promoting attractiveness or altering the appearance of an

73 individual and

74 (8) listed as a cosmetic drug subject to the exemption under this section by the division

75 by administrative rule or has been expressly approved for online dispensing whether or not it is

76 dispensed online or through a physicians office and

77 (ii) does not include a prescription drug that is

78 (A) a controlled substance

79 (8) compounded by the physician or

80 (C) prescribed or used for the patient for the purpose of diagnosing curing or

81 preventing a disease

82 (b) Injectable weight loss drug

83 (i) means an injectable prescription drug

84 (A) prescribed to promote weight loss and

85 (8) listed as an injectable prescription drug subject to exemption under this section by

86 the division by administrative rule and

87 (ii) does not include a prescription drug that is a controlled substance

88 (c) Prescribing practitioner means an individual licensed under

89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with

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HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

HB106 02-05-14 122 PM

90 prescriptive practice

91 (ii) Chapter 67 Utah Medical Practice Act

92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or

93 (iv) Chapter 70a Physician Assistant Act

94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l

95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the

96 acts or practices described in this section without being licensed under this chapter

97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the

98 individual notifies the division in writing of the individuals intent to dispense a drug under this

99 [snbsectioll] Subsection (2)

100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1

101 (c) an individual engaging in the practice of pharmacy technician under the direct

102 personal supervision of a pharmacist while making satisfactory progress in an approved

103 program as defined in division rule

104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an

105 injectable weight loss drug to the prescribing practitioners patient in accordance with

106 Subsection (4) or

107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists

108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic

109 drug to the optometrists patient in accordance with Subsection (4)

110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under

111 Subsection (2)( c) must take all examinations as required by division rule following completion

112 of an approved curriculum of education within the required time frame This exemption

113 expires immediately upon notification of a failing score of an examination and the individual

114 may not continue working as a pharmacy technician even under direct supervision

115 (4) A prescribing practitioner or optometrist is exempt from licensing under the

116 provisions of this part if the prescribing practitioner or optometrist

117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the

118 authority to dispense under Subsection (4)(b) and

119 (ii) informs the patient

120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

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HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

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HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

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02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

HB106 02-05-14 122 PM

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the

153 prescribing practitioners or optometrists office and determine if the provisions of this section

154 are being met by the prescribing practitioner or optometrist

155 (d) If a prescribing practitioner or optometrist violates a provision of this section the

156 prescribing practitioner or optometrist may be subject to discipline under

157 (i) this chapter and

158 (ii) (A) Chapter 16a Utah Optometry Practice Act

159 (B) Chapter 31 b Nurse Practice Act

160 (C) Chapter 67 Utah Medical Practice Act

161 (D) Chapter 68 Utah Osteopathic Medical Practice Act

162 (E) Chapter 70a Physician Assistant Act or

163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act

164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the

165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah

166 Optometry Practice Act

167 Section 4 Section 58-17b-3095 is amended to read

168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy

169 Division study of dispensing practitioners

170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen

171 (a) means a prescription drug used to treat cancer manage its symptoms or provide

172 continuity of care for a cancer patient

173 (b) includes

174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal

175 methods and

176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize

177 physical and psychological symptoms or pain or to improve patient tolerance of cancer

178 treatments or prepare a patient for a subsequent course of therapy and

179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug

180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections

181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt

182 from licensure under this chapter

- 6shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

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02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

HB106 02-05-14 122 PM

214 (ii) is acting under the direction of a prescribing practitioner who is immediately

215 available on site for any necessary consultation and who has complied with Subsection

216 (2)(b)(i)

217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the

218 outpatient clinic setting and

219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)

220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to

221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section

222 (b) The evaluation under this Subsection (3) shall include

223 (i) practitioner compliance with the requirements of this section and Section

224 58-l7b-309

225 (ii) current research on dispensing and patient safety

226 (iii) survey of other state dispensing laws and

227 (iv) recommendations for future action concerning practitioner dispensing

228 (c) The division shall report to the Legislatures Health and Human Services Interim

229 Committee by November 302012 and by November 302013 with the results and

230 recommendations from the evaluation required by this Subsection (3)

231 (4) This section sunsets in accordance with Section 631-1-258

232 Section 5 Section 58-17b-3097 is enacted to read

233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an

234 employer sponsored clinic

235 (1) As used in this section

236 (a) Employer sponsored clinic means an entity that offers health care only to the

237 employees of an exclusive group of employers and the employees dependents

238 (b) Health care is as defined in Section 31 A-J-301

239 (c) Prepackaged drug means a prescription drug that

240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and

241 (ii) is packaged in a fixed quantity per package by

242 (A) the drug manufacturer

243 (B) a pharmaceutical wholesaler or distributor or

244 (C) a pharmacy licensed under this title

- 8 shy

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02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

~ -- -------------------

02-05-14 122 PM HB106

245 Cd) Prescribing practitioner is as defined in Section 58-17b-309

246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309

247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing

248 requirements of this chapter if the prescribing practitioner

249 Ca) treats an employee of one of an exclusive group of employers at an employer

250 sponsored clinic

251 Cb) prescribes a prepackaged drug to the employee

252 Cc) dispenses the prepackaged drug at the employer sponsored clinic

253 (d) notifies the division

254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the

255 employer sponsored clinic and

256 (ii) of the drug the prescribing practitioner intends to dispense

257 Ce) determines that providing the prepackaged drug to the employee at the employer

258 sponsored clinic is in the employees best interest

259 (f) informs the employee

260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner

261 from a pharmacy that is unaffiliated with the prescribing practitioner

262 (ii) of the directions for appropriate use of the prepackaged drug

263 (iii) of potential side effects to the use of the prepackaged drug and

264 (iv) how to contact the prescribing practitioner if the employee has questions or

265 concerns regarding the drug

266 (g) offers the employee the opportunity to consult with a pharmacist if the employee

267 asks for patient counseling and

268 (h) follows the administrative rules for a prescribing practitioner at an employer

269 sponsored clinic established by the division under Subsection (4)

270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a

271 prepackaged drug under this section requires physician supervision in its scope ofpractice

272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the

273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter

274 68 Utah Osteopathic Medical Practice Act

275 (4) The division shall in consultation with the board of pharmacy and the Physicians

- 9 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

HBI06 02-05-14 122 PM

276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title

277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping

278 patient counseling purchasing and distribution operating treatment quality of care and

279 storage requirements for a prescribing practitioner at an employer sponsored clinic

280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a

281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing

282 practitioner is in compliance with this section

283 (6) If a prescribing practitioner violates a provision of this section the prescribing

284 practitioner may be subject to discipline under

285 (a) this chapter and

286 (b) any other chapter that governs the terms of the prescribing practitioners license

287 (7) The division shall evaluate the exemption created by this section and report to the

288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1

289 2018 on the results of the evaluation and the divisions recommendations regarding the

290 exemption

291 Section 6 Section 631-1-258 is amended to read

292 631-1-258 Repeal dates Title 58

293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is

294 repealed July 12016

295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015

296 (3) Section 58-17b-3095 is repealed July 1 2015

297 (4) Section 58-17b-3097 is repealed on July 12018

298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1

299 2018

300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1

301 2023

302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing

303 Act is repealed July 1 2019

304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1

305 2015

306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is

- 10shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy

02-05-14 1 22 PM HB106

307 repealed July 12023

308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1

309 2014

310 [ttej] ill) Section 58-69-3025 is repealed on July 12015

311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017

Legislative Review Note as of 2-3-14 418 PM

Office of Legislative Research and General Counsel

- 11 shy