This document includes House Committee Amendments incorporated into the bill on Tue, Feb 4, 2020 at 9:06 AM by pflowers.
1     
PRESCRIPTION REVISIONS

2     
2020 GENERAL SESSION

3     
STATE OF UTAH

4     
Chief Sponsor: Suzanne Harrison

5     
Senate Sponsor: Evan J. Vickers

6     

7     LONG TITLE
8     General Description:
9          This bill amends provisions relating to prescriptions for controlled substances.
10     Highlighted Provisions:
11          This bill:
12          ▸     requires, with some exceptions, that prescriptions for controlled substances be
13     issued electronically;
14          ▸     authorizes the division to create rules for certain aspects of prescribing controlled
15     substances;
16          ▸     amends the protocol for the dispensing of drugs by practitioners in the emergency
17     room; and
18          ▸     repeals Title 58, Chapter 82, Electronic Prescribing Act.
19     Money Appropriated in this Bill:
20          None
21     Other Special Clauses:
22          None
23     Utah Code Sections Affected:
24     AMENDS:
25          58-17b-610.5, as last amended by Laws of Utah 2016, Chapter 238
26          58-37-6, as last amended by Laws of Utah 2018, Chapter 318
27     REPEALS:

28          58-82-101, as enacted by Laws of Utah 2009, Chapter 47
29          58-82-102, as last amended by Laws of Utah 2010, Chapter 276
30          58-82-201, as last amended by Laws of Utah 2012, Chapter 160
31     

32     Be it enacted by the Legislature of the state of Utah:
33          Section 1. Section 58-17b-610.5 is amended to read:
34          58-17b-610.5. Dispensing in emergency department -- Patient's immediate need.
35          (1) As used in this section, "controlled substance" means a substance classified as a
36     controlled substance by the federal Controlled Substances Act, Title II, Pub. L. No. 91-513 et
37     seq., or by Chapter 37, Utah Controlled Substances Act.
38          [(1)] (2) The division shall adopt administrative rules in accordance with Title 63G,
39     Chapter 3, Utah Administrative Rulemaking Act, in consultation with hospital pharmacies and
40     the boards of practitioners authorized to prescribe prescription drugs to establish guidelines
41     under which a practitioner may dispense prescription drugs to a patient in a hospital emergency
42     department if:
43          (a) the hospital pharmacy is closed;
44          (b) in the professional judgment of the practitioner, dispensing the drug is necessary for
45     the patient's immediate needs; [and]
46          (c) dispensing the prescription drug meets protocols established by the hospital
47     pharmacy[.]; and
48          (d) the practitioner dispenses only a sufficient amount of the prescription drug as
49     necessary to last until a pharmacy can fill the prescription.
50          [(2)] (3) A practitioner in an emergency department may dispense a prescription drug
51     in accordance with Subsection [(1)] (2).
52          (4) Under Subsection (2), a practitioner may not dispense more than a two-day supply
53     of a controlled substance.
54          Section 2. Section 58-37-6 is amended to read:
55          58-37-6. License to manufacture, produce, distribute, dispense, administer, or
56     conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records
57     required -- Prescriptions.
58          (1) (a) The division may adopt rules relating to the licensing and control of the

59     manufacture, distribution, production, prescription, administration, dispensing, conducting of
60     research with, and performing of laboratory analysis upon controlled substances within this
61     state.
62          (b) The division may assess reasonable fees to defray the cost of issuing original and
63     renewal licenses under this chapter pursuant to Section 63J-1-504.
64          (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
65     administers, conducts research with, or performs laboratory analysis upon any controlled
66     substance in Schedules I through V within this state, or who proposes to engage in
67     manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
68     research with, or performing laboratory analysis upon controlled substances included in
69     Schedules I through V within this state shall obtain a license issued by the division.
70          (ii) The division shall issue each license under this chapter in accordance with a
71     two-year renewal cycle established by rule. The division may by rule extend or shorten a
72     renewal period by as much as one year to stagger the renewal cycles it administers.
73          (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
74     administer, conduct research with, or perform laboratory analysis upon controlled substances in
75     Schedules I through V within this state may possess, manufacture, produce, distribute,
76     prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
77     those substances to the extent authorized by their license and in conformity with this chapter.
78          (c) The following persons are not required to obtain a license and may lawfully possess
79     controlled substances included in Schedules II through V under this section:
80          (i) an agent or employee, except a sales representative, of any registered manufacturer,
81     distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
82     usual course of the [person's] agent or employee's business or employment; however, nothing
83     in this subsection shall be interpreted to permit an agent, employee, sales representative, or
84     detail man to maintain an inventory of controlled substances separate from the location of the
85     person's employer's registered and licensed place of business;
86          (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
87     warehouseman, who possesses [any] a controlled substance in the usual course of the person's
88     business or employment; and
89          (iii) an ultimate user, or [any] a person who possesses any controlled substance

90     pursuant to a lawful order of a practitioner.
91          (d) The division may enact rules waiving the license requirement for certain
92     manufacturers, producers, distributors, prescribers, dispensers, administrators, research
93     practitioners, or laboratories performing analysis if waiving the license requirement is
94     consistent with [the] public health and safety.
95          (e) A separate license is required at each principal place of business or professional
96     practice where the applicant manufactures, produces, distributes, dispenses, conducts research
97     with, or performs laboratory analysis upon controlled substances.
98          (f) The division may enact rules providing for the inspection of a licensee or applicant's
99     establishment, and may inspect the establishment according to those rules.
100          (3) (a) (i) Upon proper application, the division shall license a qualified applicant to
101     manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
102     controlled substances included in Schedules I through V, unless it determines that issuance of a
103     license is inconsistent with the public interest.
104          (ii) The division may not issue a license to any person to prescribe, dispense, or
105     administer a Schedule I controlled substance except under Subsection (3)(a)(i).
106          (iii) In determining public interest under this Subsection (3)(a), the division shall
107     consider whether [or not] the applicant has:
108          (A) maintained effective controls against diversion of controlled substances and any
109     Schedule I or II substance compounded from any controlled substance into channels other than
110     legitimate medical, scientific, or industrial channels;
111          (B) complied with applicable state and local law;
112          (C) been convicted under federal or state laws relating to the manufacture, distribution,
113     or dispensing of substances;
114          (D) past experience in the manufacture of controlled dangerous substances;
115          (E) established effective controls against diversion; and
116          (F) complied with any other factors that the division establishes that promote the public
117     health and safety.
118          (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
119     produce, distribute, conduct research with, or perform laboratory analysis upon controlled
120     substances in Schedule I other than those specified in the license.

121          (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
122     substances in Schedules II through V if they are authorized to administer, dispense, or conduct
123     research under the laws of this state.
124          (ii) The division need not require a separate license for practitioners engaging in
125     research with nonnarcotic controlled substances in Schedules II through V where the licensee is
126     already licensed under this chapter in another capacity.
127          (iii) With respect to research involving narcotic substances in Schedules II through V,
128     or where the division by rule requires a separate license for research of nonnarcotic substances
129     in Schedules II through V, a practitioner shall apply to the division prior to conducting
130     research.
131          (iv) Licensing for purposes of bona fide research with controlled substances by a
132     practitioner considered qualified may be denied only on a ground specified in Subsection (4),
133     or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
134     adequately the practitioner's supply of substances against diversion from medical or scientific
135     use.
136          (v) Practitioners registered under federal law to conduct research in Schedule I
137     substances may conduct research in Schedule I substances within this state upon [furnishing]
138     providing the division with evidence of federal registration.
139          (d) Compliance by manufacturers, producers, and distributors with the provisions of
140     federal law respecting registration, excluding fees, entitles them to be licensed under this
141     chapter.
142          (e) The division shall initially license those persons who own or operate an
143     establishment engaged in the manufacture, production, distribution, dispensation, or
144     administration of controlled substances prior to April 3, 1980, and who are licensed by the
145     state.
146          (4) (a) Any license issued pursuant to Subsection (2) or (3) may be denied, suspended,
147     placed on probation, or revoked by the division upon finding that the applicant or licensee has:
148          (i) materially falsified any application filed or required pursuant to this chapter;
149          (ii) been convicted of an offense under this chapter or any law of the United States, or
150     any state, relating to any substance defined as a controlled substance;
151          (iii) been convicted of a felony under any other law of the United States or any state

152     within five years of the date of the issuance of the license;
153          (iv) had a federal registration or license denied, suspended, or revoked by competent
154     federal authority and is no longer authorized to manufacture, distribute, prescribe, or dispense
155     controlled substances;
156          (v) had the licensee's license suspended or revoked by competent authority of another
157     state for violation of laws or regulations comparable to those of this state relating to the
158     manufacture, distribution, or dispensing of controlled substances;
159          (vi) violated any division rule that reflects adversely on the licensee's reliability and
160     integrity with respect to controlled substances;
161          (vii) refused inspection of records required to be maintained under this chapter by a
162     person authorized to inspect them; or
163          (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
164     purpose of manipulating human hormonal structure so as to:
165          (A) increase muscle mass, strength, or weight without medical necessity and without a
166     written prescription by any practitioner in the course of the practitioner's professional practice;
167     or
168          (B) improve performance in any form of human exercise, sport, or game.
169          (b) The division may limit revocation or suspension of a license to a particular
170     controlled substance with respect to which grounds for revocation or suspension exist.
171          (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to
172     this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
173     Occupational and Professional Licensing Act, and conducted in conjunction with the
174     appropriate representative committee designated by the director of the department.
175          (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
176     Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
177     except where the division is designated by law to perform those functions, or, when not
178     designated by law, is designated by the executive director of the Department of Commerce to
179     conduct the proceedings.
180          (d) (i) The division may suspend any license simultaneously with the institution of
181     proceedings under this section if it finds there is an imminent danger to the public health or
182     safety.

183          (ii) Suspension shall continue in effect until the conclusion of proceedings, including
184     judicial review, unless withdrawn by the division or dissolved by a court of competent
185     jurisdiction.
186          (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
187     substances owned or possessed by the licensee may be placed under seal in the discretion of the
188     division.
189          (ii) Disposition may not be made of substances under seal until the time for taking an
190     appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
191     orders the sale of perishable substances and the proceeds deposited with the court.
192          (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
193          (f) The division shall notify promptly the Drug Enforcement Administration of all
194     orders suspending or revoking a license and all forfeitures of controlled substances.
195          (g) If an individual's Drug Enforcement Administration registration is denied, revoked,
196     surrendered, or suspended, the division shall immediately suspend the individual's controlled
197     substance license, which shall only be reinstated by the division upon reinstatement of the
198     federal registration, unless the division has taken further administrative action under
199     Subsection (4)(a)(iv), which would be grounds for the continued denial of the controlled
200     substance license.
201          (5) (a) [Persons] A person licensed under Subsection (2) or (3) shall maintain records
202     and inventories in conformance with the record keeping and inventory requirements of federal
203     and state law and any additional rules issued by the division.
204          (b) (i) [Every] A physician, dentist, naturopathic physician, veterinarian, practitioner,
205     or other [person] individual who is authorized to administer or professionally use a controlled
206     substance shall keep a record of the drugs received by [him] the individual and a record of all
207     drugs administered, dispensed, or professionally used by [him] the individual otherwise than by
208     a prescription.
209          (ii) [A person] An individual using small quantities or solutions or other preparations
210     of those drugs for local application has complied with this Subsection (5)(b) if the [person]
211     individual keeps a record of the quantity, character, and potency of those solutions or
212     preparations purchased or prepared by [him] the individual, and of the dates when purchased or
213     prepared.

214          (6) Controlled substances in Schedules I through V may be distributed only by a
215     licensee and pursuant to an order form prepared in compliance with division rules or a lawful
216     order under the rules and regulations of the United States.
217          (7) (a) [A person] An individual may not write or authorize a prescription for a
218     controlled substance unless the [person] individual is:
219          (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
220     or under the laws of another state having similar standards; and
221          (ii) licensed under this chapter or under the laws of another state having similar
222     standards.
223          (b) [A person] An individual other than a pharmacist licensed under the laws of this
224     state, or the pharmacist's licensed intern, as required by Sections 58-17b-303 and 58-17b-304,
225     may not dispense a controlled substance.
226          (c) (i) A controlled substance may not be dispensed without the written prescription of
227     a practitioner, if the written prescription is required by the federal Controlled Substances Act.
228          (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
229     conformity with Subsection (7)(d).
230          (iii) In emergency situations, as defined by division rule, controlled substances may be
231     dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
232     designated by the division and filed by the pharmacy.
233          (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
234     Subsection (7)(d).
235          (d) Except for emergency situations designated by the division, [a person] an
236     individual may not issue, fill, compound, or dispense a prescription for a controlled substance
237     unless the prescription is signed by the prescriber in ink or indelible pencil or is signed with an
238     electronic signature of the prescriber as authorized by division rule, and contains the following
239     information:
240          (i) the name, address, and registry number of the prescriber;
241          (ii) the name, address, and age of the person to whom or for whom the prescription is
242     issued;
243          (iii) the date of issuance of the prescription; and
244          (iv) the name, quantity, and specific directions for use by the ultimate user of the

245     controlled substance.
246          (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
247     controlled substance unless:
248          (i) the [person] individual who writes the prescription is licensed under Subsection (2);
249     and
250          (ii) the prescribed controlled substance is to be used in research.
251          (f) Except when administered directly to an ultimate user by a licensed practitioner,
252     controlled substances are subject to the restrictions of this Subsection (7)(f).
253          (i) A prescription for a Schedule II substance may not be refilled.
254          (ii) A Schedule II controlled substance may not be filled in a quantity to exceed a
255     one-month's supply, as directed on the daily dosage rate of the prescriptions.
256          (iii) (A) Except as provided in Subsection (7)(f)(iii)(B), a prescription for a Schedule II
257     or Schedule III controlled substance that is an opiate and that is issued for an acute condition
258     shall be completely or partially filled in a quantity not to exceed a seven-day supply as directed
259     on the daily dosage rate of the prescription.
260          (B) Subsection (7)(f)(iii)(A) does not apply to a prescription issued for a surgery when
261     the practitioner determined that a quantity exceeding seven days is needed, in which case the
262     practitioner may prescribe up to a 30-day supply, with a partial fill at the discretion of the
263     practitioner.
264          (C) Subsection (7)(f)(iii)(A) does not apply to prescriptions issued for complex or
265     chronic conditions which are documented as being complex or chronic in the medical record.
266          (D) A pharmacist is not required to verify that a prescription is in compliance with
267     Subsection (7)(f)(iii).
268          (iv) A Schedule III or IV controlled substance may be filled only within six months of
269     issuance, and may not be refilled more than six months after the date of its original issuance or
270     be refilled more than five times after the date of the prescription unless renewed by the
271     practitioner.
272          (v) All other controlled substances in Schedule V may be refilled as the prescriber's
273     prescription directs, but they may not be refilled one year after the date the prescription was
274     issued unless renewed by the practitioner.
275          (vi) Any prescription for a Schedule II substance may not be dispensed if it is not

276     presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
277     after the date the prescription was issued, or 30 days after the dispensing date, if that date is
278     specified separately from the date of issue.
279          (vii) A practitioner may issue more than one prescription at the same time for the same
280     Schedule II controlled substance, but only under the following conditions:
281          (A) no more than three prescriptions for the same Schedule II controlled substance may
282     be issued at the same time;
283          (B) no one prescription may exceed a 30-day supply; and
284          (C) a second or third prescription shall include the date of issuance and the date for
285     dispensing.
286          (g) (i) Beginning January 1, 2022, each prescription issued for a controlled substance
287     shall be transmitted electronically as an electronic prescription unless the prescription is:
288          (A) for a patient residing in an assisted living facility as that term is defined in Section
289     26-21-2, a long-term care facility as that term is defined in Section 58-31b-102, or a
290     correctional facility as that term is defined in Section 64-13-1;
291          (B) issued by a veterinarian licensed under Title 58, Chapter 28, Veterinary Practice
292     Act;
293          (C) dispensed by a Department of Veterans Affairs pharmacy;
294          (D) issued during a temporary technical or electronic failure at the practitioner's or
295     pharmacy's location; or
296          (E) issued in an emergency situation.
297          (ii) The division, in collaboration with the Ĥ→ appropriate ←Ĥ boards that govern the
297a     licensure of the
298     licensees who are authorized by the division to prescribe Ĥ→ or to dispense ←Ĥ controlled
298a     substances, shall make
299     rules in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act to:
300          (A) require that controlled substances prescribed or dispensed under Subsection
301     (7)(g)(i)(D) indicate on the prescription that the prescribing practitioner or the pharamacy is
302     experiencing a technical difficulty or an electronic failure;
303          (B) define an emergency situation for purposes of Subsection (7)(g)(i)(E);
304          (C) establish additional exemptions to the electronic prescription requirements
305     established in this Subsection (7)(g);
306          (D) establish guidelines under which a prescribing practitioner or a pharmacy may

307     obtain an extension of up to two additional years to comply with Subsection (7)(g)(i);
308          (E) establish a protocol to follow if the pharmacy that receives the electronic
309     prescription is not able to fill the prescription; and
310          (F) establish requirements Ĥ→ that comply with federal laws and regulations ←Ĥ for
310a     software used to issue and dispense electronic
311     prescriptions.
312          [(g)] (h) An order for a controlled substance in Schedules II through V for use by an
313     inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
314     Subsection (7) if the order is:
315          (i) issued or made by a prescribing practitioner who holds an unrestricted registration
316     with the federal Drug Enforcement Administration, and an active Utah controlled substance
317     license in good standing issued by the division under this section, or a medical resident who is
318     exempted from licensure under Subsection 58-1-307(1)(c);
319          (ii) authorized by the prescribing practitioner treating the patient and the prescribing
320     practitioner designates the quantity ordered;
321          (iii) entered upon the record of the patient, the record is signed by the prescriber
322     affirming the prescriber's authorization of the order within 48 hours after filling or
323     administering the order, and the patient's record reflects the quantity actually administered; and
324          (iv) filled and dispensed by a pharmacist practicing the pharmacist's profession within
325     the physical structure of the hospital, or the order is taken from a supply lawfully maintained by
326     the hospital and the amount taken from the supply is administered directly to the patient
327     authorized to receive it.
328          [(h)] (i) A practitioner licensed under this chapter may not prescribe, administer, or
329     dispense a controlled substance to a child, without first obtaining the consent required in
330     Section 78B-3-406 of a parent, guardian, or person standing in loco parentis of the child except
331     in cases of an emergency. For purposes of [this] Subsection (7)[(h)](i), "child" has the same
332     meaning as defined in Section 78A-6-105, and "emergency" means any physical condition
333     requiring the administration of a controlled substance for immediate relief of pain or suffering.
334          [(i)] (j) A practitioner licensed under this chapter may not prescribe or administer
335     dosages of a controlled substance in excess of medically recognized quantities necessary to
336     treat the ailment, malady, or condition of the ultimate user.
337          [(j)] (k) A practitioner licensed under this chapter may not prescribe, administer, or

338     dispense any controlled substance to another person knowing that the other person is using a
339     false name, address, or other personal information for the purpose of securing the controlled
340     substance.
341          [(k)] (l) A person who is licensed under this chapter to manufacture, distribute, or
342     dispense a controlled substance may not manufacture, distribute, or dispense a controlled
343     substance to another licensee or any other authorized person not authorized by this license.
344          [(l)] (m) A person licensed under this chapter may not omit, remove, alter, or obliterate
345     a symbol required by this chapter or by a rule issued under this chapter.
346          [(m)] (n) A person licensed under this chapter may not refuse or fail to make, keep, or
347     furnish any record notification, order form, statement, invoice, or information required under
348     this chapter.
349          [(n)] (o) A person licensed under this chapter may not refuse entry into any premises
350     for inspection as authorized by this chapter.
351          [(o)] (p) A person licensed under this chapter may not furnish false or fraudulent
352     material information in any application, report, or other document required to be kept by this
353     chapter or willfully make any false statement in any prescription, order, report, or record
354     required by this chapter.
355          (8) (a) (i) Any person licensed under this chapter who is found by the division to have
356     violated any of the provisions of Subsections (7)(k) through (o) or Subsection (10) is subject to
357     a penalty not to exceed $5,000. The division shall determine the procedure for adjudication of
358     any violations in accordance with Sections 58-1-106 and 58-1-108.
359          (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in the
360     General Fund as a dedicated credit to be used by the division under Subsection 58-37f-502(1).
361          (iii) The director may collect a penalty that is not paid by:
362          (A) referring the matter to a collection agency; or
363          (B) bringing an action in the district court of the county where the person against
364     whom the penalty is imposed resides or in the county where the office of the director is located.
365          (iv) A county attorney or the attorney general of the state shall provide legal assistance
366     and advice to the director in an action to collect a penalty.
367          (v) A court shall award reasonable attorney fees and costs to the prevailing party in an
368     action brought by the division to collect a penalty.

369          (b) Any person who knowingly and intentionally violates Subsections (7)(h) through (j)
370     or Subsection (10) is:
371          (i) upon first conviction, guilty of a class B misdemeanor;
372          (ii) upon second conviction, guilty of a class A misdemeanor; and
373          (iii) on third or subsequent conviction, guilty of a third degree felony.
374          (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
375     (o) shall upon conviction be guilty of a third degree felony.
376          (9) Any information communicated to any licensed practitioner in an attempt to
377     unlawfully procure, or to procure the administration of, a controlled substance is not considered
378     to be a privileged communication.
379          (10) A person holding a valid license under this chapter who is engaged in medical
380     research may produce, possess, administer, prescribe, or dispense a controlled substance for
381     research purposes as licensed under Subsection (2) but may not otherwise prescribe or dispense
382     a controlled substance listed in Section 58-37-4.2.
383          Section 3. Repealer.
384          This bill repeals:
385          Section 58-82-101, Title.
386          Section 58-82-102, Definitions.
387          Section 58-82-201, Electronic prescriptions -- Restrictions -- Rulemaking
388     authority.