2
3
4
5
6 Cosponsors:
7 Cheryl K. Acton
Joel K. Briscoe
Marsha Judkins
Steve Waldrip
8
9 LONG TITLE
10 General Description:
11 This bill amends provisions relating to prescriptions for controlled substances.
12 Highlighted Provisions:
13 This bill:
14 ▸ requires, with some exceptions, that prescriptions for controlled substances be
15 issued electronically;
16 ▸ authorizes the division to create rules for certain aspects of prescribing controlled
17 substances;
18 ▸ amends the protocol for the dispensing of drugs by practitioners in the emergency
19 room; and
20 ▸ repeals Title 58, Chapter 82, Electronic Prescribing Act.
21 Money Appropriated in this Bill:
22 None
23 Other Special Clauses:
24 None
25 Utah Code Sections Affected:
26 AMENDS:
27 58-17b-610.5, as last amended by Laws of Utah 2016, Chapter 238
28 58-37-6, as last amended by Laws of Utah 2018, Chapter 318
29 REPEALS:
30 58-82-101, as enacted by Laws of Utah 2009, Chapter 47
31 58-82-102, as last amended by Laws of Utah 2010, Chapter 276
32 58-82-201, as last amended by Laws of Utah 2012, Chapter 160
33
34 Be it enacted by the Legislature of the state of Utah:
35 Section 1. Section 58-17b-610.5 is amended to read:
36 58-17b-610.5. Dispensing in emergency department -- Patient's immediate need.
37 (1) As used in this section, "controlled substance" means a substance classified as a
38 controlled substance by the federal Controlled Substances Act, Title II, Pub. L. No. 91-513 et
39 seq., or by Chapter 37, Utah Controlled Substances Act.
40 [
41 Chapter 3, Utah Administrative Rulemaking Act, in consultation with hospital pharmacies and
42 the boards of practitioners authorized to prescribe prescription drugs to establish guidelines
43 under which a practitioner may dispense prescription drugs to a patient in a hospital emergency
44 department if:
45 (a) the hospital pharmacy is closed;
46 (b) in the professional judgment of the practitioner, dispensing the drug is necessary for
47 the patient's immediate needs; [
48 (c) dispensing the prescription drug meets protocols established by the hospital
49 pharmacy[
50 (d) the practitioner dispenses only a sufficient amount of the prescription drug as
51 necessary to last until a pharmacy can fill the prescription.
52 [
53 in accordance with Subsection [
54 (4) Under Subsection (2), a practitioner may not dispense more than a two-day supply
55 of a controlled substance.
56 Section 2. Section 58-37-6 is amended to read:
57 58-37-6. License to manufacture, produce, distribute, dispense, administer, or
58 conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records
59 required -- Prescriptions.
60 (1) (a) The division may adopt rules relating to the licensing and control of the
61 manufacture, distribution, production, prescription, administration, dispensing, conducting of
62 research with, and performing of laboratory analysis upon controlled substances within this
63 state.
64 (b) The division may assess reasonable fees to defray the cost of issuing original and
65 renewal licenses under this chapter pursuant to Section 63J-1-504.
66 (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
67 administers, conducts research with, or performs laboratory analysis upon any controlled
68 substance in Schedules I through V within this state, or who proposes to engage in
69 manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
70 research with, or performing laboratory analysis upon controlled substances included in
71 Schedules I through V within this state shall obtain a license issued by the division.
72 (ii) The division shall issue each license under this chapter in accordance with a
73 two-year renewal cycle established by rule. The division may by rule extend or shorten a
74 renewal period by as much as one year to stagger the renewal cycles it administers.
75 (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
76 administer, conduct research with, or perform laboratory analysis upon controlled substances in
77 Schedules I through V within this state may possess, manufacture, produce, distribute,
78 prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
79 those substances to the extent authorized by their license and in conformity with this chapter.
80 (c) The following persons are not required to obtain a license and may lawfully possess
81 controlled substances included in Schedules II through V under this section:
82 (i) an agent or employee, except a sales representative, of any registered manufacturer,
83 distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
84 usual course of the [
85 in this subsection shall be interpreted to permit an agent, employee, sales representative, or
86 detail man to maintain an inventory of controlled substances separate from the location of the
87 person's employer's registered and licensed place of business;
88 (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
89 warehouseman, who possesses [
90 business or employment; and
91 (iii) an ultimate user, or [
92 pursuant to a lawful order of a practitioner.
93 (d) The division may enact rules waiving the license requirement for certain
94 manufacturers, producers, distributors, prescribers, dispensers, administrators, research
95 practitioners, or laboratories performing analysis if waiving the license requirement is
96 consistent with [
97 (e) A separate license is required at each principal place of business or professional
98 practice where the applicant manufactures, produces, distributes, dispenses, conducts research
99 with, or performs laboratory analysis upon controlled substances.
100 (f) The division may enact rules providing for the inspection of a licensee or applicant's
101 establishment, and may inspect the establishment according to those rules.
102 (3) (a) (i) Upon proper application, the division shall license a qualified applicant to
103 manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
104 controlled substances included in Schedules I through V, unless it determines that issuance of a
105 license is inconsistent with the public interest.
106 (ii) The division may not issue a license to any person to prescribe, dispense, or
107 administer a Schedule I controlled substance except under Subsection (3)(a)(i).
108 (iii) In determining public interest under this Subsection (3)(a), the division shall
109 consider whether [
110 (A) maintained effective controls against diversion of controlled substances and any
111 Schedule I or II substance compounded from any controlled substance into channels other than
112 legitimate medical, scientific, or industrial channels;
113 (B) complied with applicable state and local law;
114 (C) been convicted under federal or state laws relating to the manufacture, distribution,
115 or dispensing of substances;
116 (D) past experience in the manufacture of controlled dangerous substances;
117 (E) established effective controls against diversion; and
118 (F) complied with any other factors that the division establishes that promote the public
119 health and safety.
120 (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
121 produce, distribute, conduct research with, or perform laboratory analysis upon controlled
122 substances in Schedule I other than those specified in the license.
123 (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
124 substances in Schedules II through V if they are authorized to administer, dispense, or conduct
125 research under the laws of this state.
126 (ii) The division need not require a separate license for practitioners engaging in
127 research with nonnarcotic controlled substances in Schedules II through V where the licensee is
128 already licensed under this chapter in another capacity.
129 (iii) With respect to research involving narcotic substances in Schedules II through V,
130 or where the division by rule requires a separate license for research of nonnarcotic substances
131 in Schedules II through V, a practitioner shall apply to the division prior to conducting
132 research.
133 (iv) Licensing for purposes of bona fide research with controlled substances by a
134 practitioner considered qualified may be denied only on a ground specified in Subsection (4),
135 or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
136 adequately the practitioner's supply of substances against diversion from medical or scientific
137 use.
138 (v) Practitioners registered under federal law to conduct research in Schedule I
139 substances may conduct research in Schedule I substances within this state upon [
140 providing the division with evidence of federal registration.
141 (d) Compliance by manufacturers, producers, and distributors with the provisions of
142 federal law respecting registration, excluding fees, entitles them to be licensed under this
143 chapter.
144 (e) The division shall initially license those persons who own or operate an
145 establishment engaged in the manufacture, production, distribution, dispensation, or
146 administration of controlled substances prior to April 3, 1980, and who are licensed by the
147 state.
148 (4) (a) Any license issued pursuant to Subsection (2) or (3) may be denied, suspended,
149 placed on probation, or revoked by the division upon finding that the applicant or licensee has:
150 (i) materially falsified any application filed or required pursuant to this chapter;
151 (ii) been convicted of an offense under this chapter or any law of the United States, or
152 any state, relating to any substance defined as a controlled substance;
153 (iii) been convicted of a felony under any other law of the United States or any state
154 within five years of the date of the issuance of the license;
155 (iv) had a federal registration or license denied, suspended, or revoked by competent
156 federal authority and is no longer authorized to manufacture, distribute, prescribe, or dispense
157 controlled substances;
158 (v) had the licensee's license suspended or revoked by competent authority of another
159 state for violation of laws or regulations comparable to those of this state relating to the
160 manufacture, distribution, or dispensing of controlled substances;
161 (vi) violated any division rule that reflects adversely on the licensee's reliability and
162 integrity with respect to controlled substances;
163 (vii) refused inspection of records required to be maintained under this chapter by a
164 person authorized to inspect them; or
165 (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
166 purpose of manipulating human hormonal structure so as to:
167 (A) increase muscle mass, strength, or weight without medical necessity and without a
168 written prescription by any practitioner in the course of the practitioner's professional practice;
169 or
170 (B) improve performance in any form of human exercise, sport, or game.
171 (b) The division may limit revocation or suspension of a license to a particular
172 controlled substance with respect to which grounds for revocation or suspension exist.
173 (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to
174 this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
175 Occupational and Professional Licensing Act, and conducted in conjunction with the
176 appropriate representative committee designated by the director of the department.
177 (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
178 Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
179 except where the division is designated by law to perform those functions, or, when not
180 designated by law, is designated by the executive director of the Department of Commerce to
181 conduct the proceedings.
182 (d) (i) The division may suspend any license simultaneously with the institution of
183 proceedings under this section if it finds there is an imminent danger to the public health or
184 safety.
185 (ii) Suspension shall continue in effect until the conclusion of proceedings, including
186 judicial review, unless withdrawn by the division or dissolved by a court of competent
187 jurisdiction.
188 (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
189 substances owned or possessed by the licensee may be placed under seal in the discretion of the
190 division.
191 (ii) Disposition may not be made of substances under seal until the time for taking an
192 appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
193 orders the sale of perishable substances and the proceeds deposited with the court.
194 (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
195 (f) The division shall notify promptly the Drug Enforcement Administration of all
196 orders suspending or revoking a license and all forfeitures of controlled substances.
197 (g) If an individual's Drug Enforcement Administration registration is denied, revoked,
198 surrendered, or suspended, the division shall immediately suspend the individual's controlled
199 substance license, which shall only be reinstated by the division upon reinstatement of the
200 federal registration, unless the division has taken further administrative action under
201 Subsection (4)(a)(iv), which would be grounds for the continued denial of the controlled
202 substance license.
203 (5) (a) [
204 and inventories in conformance with the record keeping and inventory requirements of federal
205 and state law and any additional rules issued by the division.
206 (b) (i) [
207 or other [
208 substance shall keep a record of the drugs received by [
209 drugs administered, dispensed, or professionally used by [
210 a prescription.
211 (ii) [
212 of those drugs for local application has complied with this Subsection (5)(b) if the [
213 individual keeps a record of the quantity, character, and potency of those solutions or
214 preparations purchased or prepared by [
215 prepared.
216 (6) Controlled substances in Schedules I through V may be distributed only by a
217 licensee and pursuant to an order form prepared in compliance with division rules or a lawful
218 order under the rules and regulations of the United States.
219 (7) (a) [
220 controlled substance unless the [
221 (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
222 or under the laws of another state having similar standards; and
223 (ii) licensed under this chapter or under the laws of another state having similar
224 standards.
225 (b) [
226 state, or the pharmacist's licensed intern, as required by Sections 58-17b-303 and 58-17b-304,
227 may not dispense a controlled substance.
228 (c) (i) A controlled substance may not be dispensed without the written prescription of
229 a practitioner, if the written prescription is required by the federal Controlled Substances Act.
230 (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
231 conformity with Subsection (7)(d).
232 (iii) In emergency situations, as defined by division rule, controlled substances may be
233 dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
234 designated by the division and filed by the pharmacy.
235 (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
236 Subsection (7)(d).
237 (d) Except for emergency situations designated by the division, [
238 individual may not issue, fill, compound, or dispense a prescription for a controlled substance
239 unless the prescription is signed by the prescriber in ink or indelible pencil or is signed with an
240 electronic signature of the prescriber as authorized by division rule, and contains the following
241 information:
242 (i) the name, address, and registry number of the prescriber;
243 (ii) the name, address, and age of the person to whom or for whom the prescription is
244 issued;
245 (iii) the date of issuance of the prescription; and
246 (iv) the name, quantity, and specific directions for use by the ultimate user of the
247 controlled substance.
248 (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
249 controlled substance unless:
250 (i) the [
251 and
252 (ii) the prescribed controlled substance is to be used in research.
253 (f) Except when administered directly to an ultimate user by a licensed practitioner,
254 controlled substances are subject to the restrictions of this Subsection (7)(f).
255 (i) A prescription for a Schedule II substance may not be refilled.
256 (ii) A Schedule II controlled substance may not be filled in a quantity to exceed a
257 one-month's supply, as directed on the daily dosage rate of the prescriptions.
258 (iii) (A) Except as provided in Subsection (7)(f)(iii)(B), a prescription for a Schedule II
259 or Schedule III controlled substance that is an opiate and that is issued for an acute condition
260 shall be completely or partially filled in a quantity not to exceed a seven-day supply as directed
261 on the daily dosage rate of the prescription.
262 (B) Subsection (7)(f)(iii)(A) does not apply to a prescription issued for a surgery when
263 the practitioner determined that a quantity exceeding seven days is needed, in which case the
264 practitioner may prescribe up to a 30-day supply, with a partial fill at the discretion of the
265 practitioner.
266 (C) Subsection (7)(f)(iii)(A) does not apply to prescriptions issued for complex or
267 chronic conditions which are documented as being complex or chronic in the medical record.
268 (D) A pharmacist is not required to verify that a prescription is in compliance with
269 Subsection (7)(f)(iii).
270 (iv) A Schedule III or IV controlled substance may be filled only within six months of
271 issuance, and may not be refilled more than six months after the date of its original issuance or
272 be refilled more than five times after the date of the prescription unless renewed by the
273 practitioner.
274 (v) All other controlled substances in Schedule V may be refilled as the prescriber's
275 prescription directs, but they may not be refilled one year after the date the prescription was
276 issued unless renewed by the practitioner.
277 (vi) Any prescription for a Schedule II substance may not be dispensed if it is not
278 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
279 after the date the prescription was issued, or 30 days after the dispensing date, if that date is
280 specified separately from the date of issue.
281 (vii) A practitioner may issue more than one prescription at the same time for the same
282 Schedule II controlled substance, but only under the following conditions:
283 (A) no more than three prescriptions for the same Schedule II controlled substance may
284 be issued at the same time;
285 (B) no one prescription may exceed a 30-day supply; and
286 (C) a second or third prescription shall include the date of issuance and the date for
287 dispensing.
288 (g) (i) Beginning January 1, 2022, each prescription issued for a controlled substance
289 shall be transmitted electronically as an electronic prescription unless the prescription is:
290 (A) for a patient residing in an assisted living facility as that term is defined in Section
291 26-21-2, a long-term care facility as that term is defined in Section 58-31b-102, or a
292 correctional facility as that term is defined in Section 64-13-1;
293 (B) issued by a veterinarian licensed under Title 58, Chapter 28, Veterinary Practice
294 Act;
295 (C) dispensed by a Department of Veterans Affairs pharmacy;
296 (D) issued during a temporary technical or electronic failure at the practitioner's or
297 pharmacy's location; or
298 (E) issued in an emergency situation.
299 (ii) The division, in collaboration with the appropriate boards that govern the licensure
300 of the licensees who are authorized by the division to prescribe or to dispense controlled
301 substances, shall make rules in accordance with Title 63G, Chapter 3, Utah Administrative
302 Rulemaking Act to:
303 (A) require that controlled substances prescribed or dispensed under Subsection
304 (7)(g)(i)(D) indicate on the prescription that the prescribing practitioner or the pharamacy is
305 experiencing a technical difficulty or an electronic failure;
306 (B) define an emergency situation for purposes of Subsection (7)(g)(i)(E);
307 (C) establish additional exemptions to the electronic prescription requirements
308 established in this Subsection (7)(g);
309 (D) establish guidelines under which a prescribing practitioner or a pharmacy may
310 obtain an extension of up to two additional years to comply with Subsection (7)(g)(i);
311 (E) establish a protocol to follow if the pharmacy that receives the electronic
312 prescription is not able to fill the prescription; and
313 (F) establish requirements that comply with federal laws and regulations for software
314 used to issue and dispense electronic prescriptions.
315 [
316 inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
317 Subsection (7) if the order is:
318 (i) issued or made by a prescribing practitioner who holds an unrestricted registration
319 with the federal Drug Enforcement Administration, and an active Utah controlled substance
320 license in good standing issued by the division under this section, or a medical resident who is
321 exempted from licensure under Subsection 58-1-307(1)(c);
322 (ii) authorized by the prescribing practitioner treating the patient and the prescribing
323 practitioner designates the quantity ordered;
324 (iii) entered upon the record of the patient, the record is signed by the prescriber
325 affirming the prescriber's authorization of the order within 48 hours after filling or
326 administering the order, and the patient's record reflects the quantity actually administered; and
327 (iv) filled and dispensed by a pharmacist practicing the pharmacist's profession within
328 the physical structure of the hospital, or the order is taken from a supply lawfully maintained by
329 the hospital and the amount taken from the supply is administered directly to the patient
330 authorized to receive it.
331 [
332 dispense a controlled substance to a child, without first obtaining the consent required in
333 Section 78B-3-406 of a parent, guardian, or person standing in loco parentis of the child except
334 in cases of an emergency. For purposes of [
335 meaning as defined in Section 78A-6-105, and "emergency" means any physical condition
336 requiring the administration of a controlled substance for immediate relief of pain or suffering.
337 [
338 dosages of a controlled substance in excess of medically recognized quantities necessary to
339 treat the ailment, malady, or condition of the ultimate user.
340 [
341 dispense any controlled substance to another person knowing that the other person is using a
342 false name, address, or other personal information for the purpose of securing the controlled
343 substance.
344 [
345 dispense a controlled substance may not manufacture, distribute, or dispense a controlled
346 substance to another licensee or any other authorized person not authorized by this license.
347 [
348 a symbol required by this chapter or by a rule issued under this chapter.
349 [
350 furnish any record notification, order form, statement, invoice, or information required under
351 this chapter.
352 [
353 for inspection as authorized by this chapter.
354 [
355 material information in any application, report, or other document required to be kept by this
356 chapter or willfully make any false statement in any prescription, order, report, or record
357 required by this chapter.
358 (8) (a) (i) Any person licensed under this chapter who is found by the division to have
359 violated any of the provisions of Subsections (7)(k) through (o) or Subsection (10) is subject to
360 a penalty not to exceed $5,000. The division shall determine the procedure for adjudication of
361 any violations in accordance with Sections 58-1-106 and 58-1-108.
362 (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in the
363 General Fund as a dedicated credit to be used by the division under Subsection 58-37f-502(1).
364 (iii) The director may collect a penalty that is not paid by:
365 (A) referring the matter to a collection agency; or
366 (B) bringing an action in the district court of the county where the person against
367 whom the penalty is imposed resides or in the county where the office of the director is located.
368 (iv) A county attorney or the attorney general of the state shall provide legal assistance
369 and advice to the director in an action to collect a penalty.
370 (v) A court shall award reasonable attorney fees and costs to the prevailing party in an
371 action brought by the division to collect a penalty.
372 (b) Any person who knowingly and intentionally violates Subsections (7)(h) through (j)
373 or Subsection (10) is:
374 (i) upon first conviction, guilty of a class B misdemeanor;
375 (ii) upon second conviction, guilty of a class A misdemeanor; and
376 (iii) on third or subsequent conviction, guilty of a third degree felony.
377 (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
378 (o) shall upon conviction be guilty of a third degree felony.
379 (9) Any information communicated to any licensed practitioner in an attempt to
380 unlawfully procure, or to procure the administration of, a controlled substance is not considered
381 to be a privileged communication.
382 (10) A person holding a valid license under this chapter who is engaged in medical
383 research may produce, possess, administer, prescribe, or dispense a controlled substance for
384 research purposes as licensed under Subsection (2) but may not otherwise prescribe or dispense
385 a controlled substance listed in Section 58-37-4.2.
386 Section 3. Repealer.
387 This bill repeals:
388 Section 58-82-101, Title.
389 Section 58-82-102, Definitions.
390 Section 58-82-201, Electronic prescriptions -- Restrictions -- Rulemaking
391 authority.
392