2
3
4
5
6 Cosponsors:
7 Cheryl K. Acton
8 Stewart E. Barlow
Stephen G. Handy
Suzanne Harrison
Candice B. Pierucci
Elizabeth Weight
9
10 LONG TITLE
11 General Description:
12 This bill amends provisions relating to an electronic prescription for a controlled
13 substance.
14 Highlighted Provisions:
15 This bill:
16 ▸ requires a pharmacy software system that receives electronic prescriptions for a
17 controlled substance to allow an unfilled prescription to be transferred to a different
18 pharmacy; and
19 ▸ makes technical changes.
20 Money Appropriated in this Bill:
21 None
22 Other Special Clauses:
23 None
24 Utah Code Sections Affected:
25 AMENDS:
26 58-37-6, as last amended by Laws of Utah 2020, Chapter 81
27 ENACTS:
28 58-37-22, Utah Code Annotated 1953
29
30 Be it enacted by the Legislature of the state of Utah:
31 Section 1. Section 58-37-6 is amended to read:
32 58-37-6. License to manufacture, produce, distribute, dispense, administer, or
33 conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records
34 required -- Prescriptions.
35 (1) (a) The division may adopt rules relating to the licensing and control of the
36 manufacture, distribution, production, prescription, administration, dispensing, conducting of
37 research with, and performing of laboratory analysis upon controlled substances within this
38 state.
39 (b) The division may assess reasonable fees to defray the cost of issuing original and
40 renewal licenses under this chapter pursuant to Section 63J-1-504.
41 (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
42 administers, conducts research with, or performs laboratory analysis upon any controlled
43 substance in Schedules I through V within this state, or who proposes to engage in
44 manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
45 research with, or performing laboratory analysis upon controlled substances included in
46 Schedules I through V within this state shall obtain a license issued by the division.
47 (ii) The division shall issue each license under this chapter in accordance with a
48 two-year renewal cycle established by rule. The division may by rule extend or shorten a
49 renewal period by as much as one year to stagger the renewal cycles it administers.
50 (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
51 administer, conduct research with, or perform laboratory analysis upon controlled substances in
52 Schedules I through V within this state may possess, manufacture, produce, distribute,
53 prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
54 those substances to the extent authorized by their license and in conformity with this chapter.
55 (c) The following persons are not required to obtain a license and may lawfully possess
56 controlled substances included in Schedules II through V under this section:
57 (i) an agent or employee, except a sales representative, of any registered manufacturer,
58 distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
59 usual course of the agent or employee's business or employment; however, nothing in this
60 subsection shall be interpreted to permit an agent, employee, sales representative, or detail man
61 to maintain an inventory of controlled substances separate from the location of the person's
62 employer's registered and licensed place of business;
63 (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
64 warehouseman, who possesses a controlled substance in the usual course of the person's
65 business or employment; and
66 (iii) an ultimate user, or a person who possesses any controlled substance pursuant to a
67 lawful order of a practitioner.
68 (d) The division may enact rules waiving the license requirement for certain
69 manufacturers, producers, distributors, prescribers, dispensers, administrators, research
70 practitioners, or laboratories performing analysis if waiving the license requirement is
71 consistent with public health and safety.
72 (e) A separate license is required at each principal place of business or professional
73 practice where the applicant manufactures, produces, distributes, dispenses, conducts research
74 with, or performs laboratory analysis upon controlled substances.
75 (f) The division may enact rules providing for the inspection of a licensee or applicant's
76 establishment, and may inspect the establishment according to those rules.
77 (3) (a) (i) Upon proper application, the division shall license a qualified applicant to
78 manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
79 controlled substances included in Schedules I through V, unless it determines that issuance of a
80 license is inconsistent with the public interest.
81 (ii) The division may not issue a license to any person to prescribe, dispense, or
82 administer a Schedule I controlled substance except under Subsection (3)(a)(i).
83 (iii) In determining public interest under this Subsection (3)(a), the division shall
84 consider whether the applicant has:
85 (A) maintained effective controls against diversion of controlled substances and any
86 Schedule I or II substance compounded from any controlled substance into channels other than
87 legitimate medical, scientific, or industrial channels;
88 (B) complied with applicable state and local law;
89 (C) been convicted under federal or state laws relating to the manufacture, distribution,
90 or dispensing of substances;
91 (D) past experience in the manufacture of controlled dangerous substances;
92 (E) established effective controls against diversion; and
93 (F) complied with any other factors that the division establishes that promote the public
94 health and safety.
95 (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
96 produce, distribute, conduct research with, or perform laboratory analysis upon controlled
97 substances in Schedule I other than those specified in the license.
98 (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
99 substances in Schedules II through V if they are authorized to administer, dispense, or conduct
100 research under the laws of this state.
101 (ii) The division need not require a separate license for practitioners engaging in
102 research with nonnarcotic controlled substances in Schedules II through V where the licensee is
103 already licensed under this chapter in another capacity.
104 (iii) With respect to research involving narcotic substances in Schedules II through V,
105 or where the division by rule requires a separate license for research of nonnarcotic substances
106 in Schedules II through V, a practitioner shall apply to the division prior to conducting
107 research.
108 (iv) Licensing for purposes of bona fide research with controlled substances by a
109 practitioner considered qualified may be denied only on a ground specified in Subsection (4),
110 or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
111 adequately the practitioner's supply of substances against diversion from medical or scientific
112 use.
113 (v) Practitioners registered under federal law to conduct research in Schedule I
114 substances may conduct research in Schedule I substances within this state upon providing the
115 division with evidence of federal registration.
116 (d) Compliance by manufacturers, producers, and distributors with the provisions of
117 federal law respecting registration, excluding fees, entitles them to be licensed under this
118 chapter.
119 (e) The division shall initially license those persons who own or operate an
120 establishment engaged in the manufacture, production, distribution, dispensation, or
121 administration of controlled substances prior to April 3, 1980, and who are licensed by the
122 state.
123 (4) (a) Any license issued pursuant to Subsection (2) or (3) may be denied, suspended,
124 placed on probation, or revoked by the division upon finding that the applicant or licensee has:
125 (i) materially falsified any application filed or required pursuant to this chapter;
126 (ii) been convicted of an offense under this chapter or any law of the United States, or
127 any state, relating to any substance defined as a controlled substance;
128 (iii) been convicted of a felony under any other law of the United States or any state
129 within five years of the date of the issuance of the license;
130 (iv) had a federal registration or license denied, suspended, or revoked by competent
131 federal authority and is no longer authorized to manufacture, distribute, prescribe, or dispense
132 controlled substances;
133 (v) had the licensee's license suspended or revoked by competent authority of another
134 state for violation of laws or regulations comparable to those of this state relating to the
135 manufacture, distribution, or dispensing of controlled substances;
136 (vi) violated any division rule that reflects adversely on the licensee's reliability and
137 integrity with respect to controlled substances;
138 (vii) refused inspection of records required to be maintained under this chapter by a
139 person authorized to inspect them; or
140 (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
141 purpose of manipulating human hormonal structure so as to:
142 (A) increase muscle mass, strength, or weight without medical necessity and without a
143 written prescription by any practitioner in the course of the practitioner's professional practice;
144 or
145 (B) improve performance in any form of human exercise, sport, or game.
146 (b) The division may limit revocation or suspension of a license to a particular
147 controlled substance with respect to which grounds for revocation or suspension exist.
148 (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to
149 this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
150 Occupational and Professional Licensing Act, and conducted in conjunction with the
151 appropriate representative committee designated by the director of the department.
152 (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
153 Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
154 except where the division is designated by law to perform those functions, or, when not
155 designated by law, is designated by the executive director of the Department of Commerce to
156 conduct the proceedings.
157 (d) (i) The division may suspend any license simultaneously with the institution of
158 proceedings under this section if it finds there is an imminent danger to the public health or
159 safety.
160 (ii) Suspension shall continue in effect until the conclusion of proceedings, including
161 judicial review, unless withdrawn by the division or dissolved by a court of competent
162 jurisdiction.
163 (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
164 substances owned or possessed by the licensee may be placed under seal in the discretion of the
165 division.
166 (ii) Disposition may not be made of substances under seal until the time for taking an
167 appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
168 orders the sale of perishable substances and the proceeds deposited with the court.
169 (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
170 (f) The division shall notify promptly the Drug Enforcement Administration of all
171 orders suspending or revoking a license and all forfeitures of controlled substances.
172 (g) If an individual's Drug Enforcement Administration registration is denied, revoked,
173 surrendered, or suspended, the division shall immediately suspend the individual's controlled
174 substance license, which shall only be reinstated by the division upon reinstatement of the
175 federal registration, unless the division has taken further administrative action under
176 Subsection (4)(a)(iv), which would be grounds for the continued denial of the controlled
177 substance license.
178 (5) (a) A person licensed under Subsection (2) or (3) shall maintain records and
179 inventories in conformance with the record keeping and inventory requirements of federal and
180 state law and any additional rules issued by the division.
181 (b) (i) A physician, dentist, naturopathic physician, veterinarian, practitioner, or other
182 individual who is authorized to administer or professionally use a controlled substance shall
183 keep a record of the drugs received by the individual and a record of all drugs administered,
184 dispensed, or professionally used by the individual otherwise than by a prescription.
185 (ii) An individual using small quantities or solutions or other preparations of those
186 drugs for local application has complied with this Subsection (5)(b) if the individual keeps a
187 record of the quantity, character, and potency of those solutions or preparations purchased or
188 prepared by the individual, and of the dates when purchased or prepared.
189 (6) Controlled substances in Schedules I through V may be distributed only by a
190 licensee and pursuant to an order form prepared in compliance with division rules or a lawful
191 order under the rules and regulations of the United States.
192 (7) (a) An individual may not write or authorize a prescription for a controlled
193 substance unless the individual is:
194 (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
195 or under the laws of another state having similar standards; and
196 (ii) licensed under this chapter or under the laws of another state having similar
197 standards.
198 (b) An individual other than a pharmacist licensed under the laws of this state, or the
199 pharmacist's licensed intern, as required by Sections 58-17b-303 and 58-17b-304, may not
200 dispense a controlled substance.
201 (c) (i) A controlled substance may not be dispensed without the written prescription of
202 a practitioner, if the written prescription is required by the federal Controlled Substances Act.
203 (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
204 conformity with Subsection (7)(d).
205 (iii) In emergency situations, as defined by division rule, controlled substances may be
206 dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
207 designated by the division and filed by the pharmacy.
208 (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
209 Subsection (7)(d).
210 (d) Except for emergency situations designated by the division, an individual may not
211 issue, fill, compound, or dispense a prescription for a controlled substance unless the
212 prescription is signed by the prescriber in ink or indelible pencil or is signed with an electronic
213 signature of the prescriber as authorized by division rule, and contains the following
214 information:
215 (i) the name, address, and registry number of the prescriber;
216 (ii) the name, address, and age of the person to whom or for whom the prescription is
217 issued;
218 (iii) the date of issuance of the prescription; and
219 (iv) the name, quantity, and specific directions for use by the ultimate user of the
220 controlled substance.
221 (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
222 controlled substance unless:
223 (i) the individual who writes the prescription is licensed under Subsection (2); and
224 (ii) the prescribed controlled substance is to be used in research.
225 (f) Except when administered directly to an ultimate user by a licensed practitioner,
226 controlled substances are subject to the restrictions of this Subsection (7)(f).
227 (i) A prescription for a Schedule II substance may not be refilled.
228 (ii) A Schedule II controlled substance may not be filled in a quantity to exceed a
229 one-month's supply, as directed on the daily dosage rate of the prescriptions.
230 (iii) (A) Except as provided in Subsection (7)(f)(iii)(B), a prescription for a Schedule II
231 or Schedule III controlled substance that is an opiate and that is issued for an acute condition
232 shall be completely or partially filled in a quantity not to exceed a seven-day supply as directed
233 on the daily dosage rate of the prescription.
234 (B) Subsection (7)(f)(iii)(A) does not apply to a prescription issued for a surgery when
235 the practitioner determined that a quantity exceeding seven days is needed, in which case the
236 practitioner may prescribe up to a 30-day supply, with a partial fill at the discretion of the
237 practitioner.
238 (C) Subsection (7)(f)(iii)(A) does not apply to prescriptions issued for complex or
239 chronic conditions which are documented as being complex or chronic in the medical record.
240 (D) A pharmacist is not required to verify that a prescription is in compliance with
241 Subsection (7)(f)(iii).
242 (iv) A Schedule III or IV controlled substance may be filled only within six months of
243 issuance, and may not be refilled more than six months after the date of its original issuance or
244 be refilled more than five times after the date of the prescription unless renewed by the
245 practitioner.
246 (v) All other controlled substances in Schedule V may be refilled as the prescriber's
247 prescription directs, but they may not be refilled one year after the date the prescription was
248 issued unless renewed by the practitioner.
249 (vi) Any prescription for a Schedule II substance may not be dispensed if it is not
250 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
251 after the date the prescription was issued, or 30 days after the dispensing date, if that date is
252 specified separately from the date of issue.
253 (vii) A practitioner may issue more than one prescription at the same time for the same
254 Schedule II controlled substance, but only under the following conditions:
255 (A) no more than three prescriptions for the same Schedule II controlled substance may
256 be issued at the same time;
257 (B) no one prescription may exceed a 30-day supply; and
258 (C) a second or third prescription shall include the date of issuance and the date for
259 dispensing.
260 [
261
262 [
263
264
265 [
266
267 [
268 [
269
270 [
271 [
272
273
274
275 [
276
277
278 [
279 [
280
281 [
282
283 [
284
285 [
286
287 [
288 inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
289 Subsection (7) if the order is:
290 (i) issued or made by a prescribing practitioner who holds an unrestricted registration
291 with the federal Drug Enforcement Administration, and an active Utah controlled substance
292 license in good standing issued by the division under this section, or a medical resident who is
293 exempted from licensure under Subsection 58-1-307(1)(c);
294 (ii) authorized by the prescribing practitioner treating the patient and the prescribing
295 practitioner designates the quantity ordered;
296 (iii) entered upon the record of the patient, the record is signed by the prescriber
297 affirming the prescriber's authorization of the order within 48 hours after filling or
298 administering the order, and the patient's record reflects the quantity actually administered; and
299 (iv) filled and dispensed by a pharmacist practicing the pharmacist's profession within
300 the physical structure of the hospital, or the order is taken from a supply lawfully maintained by
301 the hospital and the amount taken from the supply is administered directly to the patient
302 authorized to receive it.
303 [
304 dispense a controlled substance to a child, without first obtaining the consent required in
305 Section 78B-3-406 of a parent, guardian, or person standing in loco parentis of the child except
306 in cases of an emergency. For purposes of Subsection (7)[
307 as defined in Section 78A-6-105, and "emergency" means any physical condition requiring the
308 administration of a controlled substance for immediate relief of pain or suffering.
309 [
310 dosages of a controlled substance in excess of medically recognized quantities necessary to
311 treat the ailment, malady, or condition of the ultimate user.
312 [
313 dispense any controlled substance to another person knowing that the other person is using a
314 false name, address, or other personal information for the purpose of securing the controlled
315 substance.
316 [
317 dispense a controlled substance may not manufacture, distribute, or dispense a controlled
318 substance to another licensee or any other authorized person not authorized by this license.
319 [
320 a symbol required by this chapter or by a rule issued under this chapter.
321 [
322 furnish any record notification, order form, statement, invoice, or information required under
323 this chapter.
324 [
325 for inspection as authorized by this chapter.
326 [
327 material information in any application, report, or other document required to be kept by this
328 chapter or willfully make any false statement in any prescription, order, report, or record
329 required by this chapter.
330 (8) (a) (i) Any person licensed under this chapter who is found by the division to have
331 violated any of the provisions of Subsections (7)(k) through (o) or Subsection (10) is subject to
332 a penalty not to exceed $5,000. The division shall determine the procedure for adjudication of
333 any violations in accordance with Sections 58-1-106 and 58-1-108.
334 (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) [
335 the General Fund as a dedicated credit to be used by the division under Subsection
336 58-37f-502(1).
337 (iii) The director may collect a penalty that is not paid by:
338 (A) referring the matter to a collection agency; or
339 (B) bringing an action in the district court of the county where the person against
340 whom the penalty is imposed resides or in the county where the office of the director is located.
341 (iv) A county attorney or the attorney general of the state shall provide legal assistance
342 and advice to the director in an action to collect a penalty.
343 (v) A court shall award reasonable attorney fees and costs to the prevailing party in an
344 action brought by the division to collect a penalty.
345 (b) Any person who knowingly and intentionally violates Subsections (7)(h) through (j)
346 or Subsection (10) is:
347 (i) upon first conviction, guilty of a class B misdemeanor;
348 (ii) upon second conviction, guilty of a class A misdemeanor; and
349 (iii) on third or subsequent conviction, guilty of a third degree felony.
350 (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
351 (o) shall upon conviction be guilty of a third degree felony.
352 (9) Any information communicated to any licensed practitioner in an attempt to
353 unlawfully procure, or to procure the administration of, a controlled substance is not considered
354 to be a privileged communication.
355 (10) A person holding a valid license under this chapter who is engaged in medical
356 research may produce, possess, administer, prescribe, or dispense a controlled substance for
357 research purposes as licensed under Subsection (2) but may not otherwise prescribe or dispense
358 a controlled substance listed in Section 58-37-4.2.
359 Section 2. Section 58-37-22 is enacted to read:
360 58-37-22. Electronic prescriptions for controlled substances.
361 (1) Beginning January 1, 2022, each prescription issued for a controlled substance shall
362 be transmitted electronically as an electronic prescription unless the prescription is:
363 (a) for a patient residing in an assisted living facility as that term is defined in Section
364 26-21-2, a long-term care facility as that term is defined in Section 58-31b-102, or a
365 correctional facility as that term is defined in Section 64-13-1;
366 (b) issued by a veterinarian licensed under Title 58, Chapter 28, Veterinary Practice
367 Act;
368 (c) dispensed by a Department of Veterans Affairs pharmacy;
369 (d) issued during a temporary technical or electronic failure at the practitioner's or
370 pharmacy's location; or
371 (e) issued in an emergency situation.
372 (2) The division, in collaboration with the appropriate boards that govern the licensure
373 of the licensees who are authorized by the division to prescribe or to dispense controlled
374 substances, shall make rules in accordance with Title 63G, Chapter 3, Utah Administrative
375 Rulemaking Act, to:
376 (a) require that controlled substances prescribed or dispensed under Subsection (1)(d)
377 indicate on the prescription that the prescribing practitioner or the pharmacy is experiencing a
378 technical difficulty or an electronic failure;
379 (b) define an emergency situation for purposes of Subsection (1)(e);
380 (c) establish additional exemptions to the electronic prescription requirements
381 established in this section;
382 (d) establish guidelines under which a prescribing practitioner or a pharmacy may
383 obtain an extension of up to two additional years to comply with Subsection (1);
384 (e) establish a protocol to follow if the pharmacy that receives the electronic
385 prescription is not able to fill the prescription; and
386 (f) establish requirements that comply with federal laws and regulations for software
387 used to issue and dispense electronic prescriptions.
388 (3) Beginning July 1, 2024, a pharmacy software program for receiving an electronic
389 prescription for a controlled substance shall be capable of electronically transferring a
390 prescription to a different pharmacy:
391 (a) upon the request of the patient or the practitioner;
392 (b) with the approval of a pharmacist at the originating pharmacy; and
393 (c) if the prescription is unfilled.