S.B. 138
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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
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22 Be it enacted by the Legislature of the state of Utah:
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 required -- Prescriptions.
27 (1) (a) The division may adopt rules relating to the licensing and control of the
28 manufacture, distribution, production, prescription, administration, dispensing, conducting of
29 research with, and performing of laboratory analysis upon controlled substances within this
30 state.
31 (b) The division may assess reasonable fees to defray the cost of issuing original and
32 renewal licenses under this chapter pursuant to Section 63J-1-504 .
33 (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
34 administers, conducts research with, or performs laboratory analysis upon any controlled
35 substance in Schedules I through V within this state, or who proposes to engage in
36 manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
37 research with, or performing laboratory analysis upon controlled substances included in
38 Schedules I through V within this state shall obtain a license issued by the division.
39 (ii) The division shall issue each license under this chapter in accordance with a
40 two-year renewal cycle established by rule. The division may by rule extend or shorten a
41 renewal period by as much as one year to stagger the renewal cycles it administers.
42 (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
43 administer, conduct research with, or perform laboratory analysis upon controlled substances in
44 Schedules I through V within this state may possess, manufacture, produce, distribute,
45 prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
46 those substances to the extent authorized by their license and in conformity with this chapter.
47 (c) The following persons are not required to obtain a license and may lawfully possess
48 controlled substances included in Schedules II through V under this section:
49 (i) an agent or employee, except a sales representative, of any registered manufacturer,
50 distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
51 usual course of the person's business or employment; however, nothing in this subsection shall
52 be interpreted to permit an agent, employee, sales representative, or detail man to maintain an
53 inventory of controlled substances separate from the location of the person's employer's
54 registered and licensed place of business;
55 (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
56 warehouseman, who possesses any controlled substance in the usual course of the person's
57 business or employment; and
58 (iii) an ultimate user, or any person who possesses any controlled substance pursuant to
59 a lawful order of a practitioner.
60 (d) The division may enact rules waiving the license requirement for certain
61 manufacturers, producers, distributors, prescribers, dispensers, administrators, research
62 practitioners, or laboratories performing analysis if consistent with the public health and safety.
63 (e) A separate license is required at each principal place of business or professional
64 practice where the applicant manufactures, produces, distributes, dispenses, conducts research
65 with, or performs laboratory analysis upon controlled substances.
66 (f) The division may enact rules providing for the inspection of a licensee or applicant's
67 establishment, and may inspect the establishment according to those rules.
68 (3) (a) (i) Upon proper application, the division shall license a qualified applicant to
69 manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
70 controlled substances included in Schedules I through V, unless it determines that issuance of a
71 license is inconsistent with the public interest.
72 (ii) The division may not issue a license to any person to prescribe, dispense, or
73 administer a Schedule I controlled substance except under Subsection (3)(a)(i).
74 (iii) In determining public interest under this Subsection (3)(a), the division shall
75 consider whether or not the applicant has:
76 (A) maintained effective controls against diversion of controlled substances and any
77 Schedule I or II substance compounded from any controlled substance into other than
78 legitimate medical, scientific, or industrial channels;
79 (B) complied with applicable state and local law;
80 (C) been convicted under federal or state laws relating to the manufacture, distribution,
81 or dispensing of substances;
82 (D) past experience in the manufacture of controlled dangerous substances;
83 (E) established effective controls against diversion; and
84 (F) complied with any other factors that the division establishes that promote the public
85 health and safety.
86 (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
87 produce, distribute, conduct research with, or perform laboratory analysis upon controlled
88 substances in Schedule I other than those specified in the license.
89 (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
90 substances in Schedules II through V if they are authorized to administer, dispense, or conduct
91 research under the laws of this state.
92 (ii) The division need not require a separate license for practitioners engaging in
93 research with nonnarcotic controlled substances in Schedules II through V where the licensee is
94 already licensed under this chapter in another capacity.
95 (iii) With respect to research involving narcotic substances in Schedules II through V,
96 or where the division by rule requires a separate license for research of nonnarcotic substances
97 in Schedules II through V, a practitioner shall apply to the division prior to conducting
98 research.
99 (iv) Licensing for purposes of bona fide research with controlled substances by a
100 practitioner considered qualified may be denied only on a ground specified in Subsection (4),
101 or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
102 adequately the practitioner's supply of substances against diversion from medical or scientific
103 use.
104 (v) Practitioners registered under federal law to conduct research in Schedule I
105 substances may conduct research in Schedule I substances within this state upon furnishing the
106 division evidence of federal registration.
107 (d) Compliance by manufacturers, producers, and distributors with the provisions of
108 federal law respecting registration, excluding fees, entitles them to be licensed under this
109 chapter.
110 (e) The division shall initially license those persons who own or operate an
111 establishment engaged in the manufacture, production, distribution, dispensation, or
112 administration of controlled substances prior to April 3, 1980, and who are licensed by the
113 state.
114 (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed
115 on probation, or revoked by the division upon finding that the applicant or licensee has:
116 (i) materially falsified any application filed or required pursuant to this chapter;
117 (ii) been convicted of an offense under this chapter or any law of the United States, or
118 any state, relating to any substance defined as a controlled substance;
119 (iii) been convicted of a felony under any other law of the United States or any state
120 within five years of the date of the issuance of the license;
121 (iv) had a federal registration or license denied, suspended, or revoked by competent
122 federal authority and is no longer authorized to manufacture, distribute, prescribe, or dispense
123 controlled substances;
124 (v) had the licensee's license suspended or revoked by competent authority of another
125 state for violation of laws or regulations comparable to those of this state relating to the
126 manufacture, distribution, or dispensing of controlled substances;
127 (vi) violated any division rule that reflects adversely on the licensee's reliability and
128 integrity with respect to controlled substances;
129 (vii) refused inspection of records required to be maintained under this chapter by a
130 person authorized to inspect them; or
131 (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
132 purpose of manipulating human hormonal structure so as to:
133 (A) increase muscle mass, strength, or weight without medical necessity and without a
134 written prescription by any practitioner in the course of the practitioner's professional practice;
135 or
136 (B) improve performance in any form of human exercise, sport, or game.
137 (b) The division may limit revocation or suspension of a license to a particular
138 controlled substance with respect to which grounds for revocation or suspension exist.
139 (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to
140 this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
141 Occupational and Professional Licensing Act, and conducted in conjunction with the
142 appropriate representative committee designated by the director of the department.
143 (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
144 Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
145 except where the division is designated by law to perform those functions, or, when not
146 designated by law, is designated by the executive director of the Department of Commerce to
147 conduct the proceedings.
148 (d) (i) The division may suspend any license simultaneously with the institution of
149 proceedings under this section if it finds there is an imminent danger to the public health or
150 safety.
151 (ii) Suspension shall continue in effect until the conclusion of proceedings, including
152 judicial review, unless withdrawn by the division or dissolved by a court of competent
153 jurisdiction.
154 (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
155 substances owned or possessed by the licensee may be placed under seal in the discretion of the
156 division.
157 (ii) Disposition may not be made of substances under seal until the time for taking an
158 appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
159 orders the sale of perishable substances and the proceeds deposited with the court.
160 (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
161 (f) The division shall notify promptly the Drug Enforcement Administration of all
162 orders suspending or revoking a license and all forfeitures of controlled substances.
163 (g) If an individual's Drug Enforcement Administration registration is denied, revoked,
164 surrendered, or suspended, the division shall immediately suspend the individual's controlled
165 substance license, which shall only be reinstated by the division upon reinstatement of the
166 federal registration, unless the division has taken further administrative action under
167 Subsection (4)(a)(iv), which would be grounds for the continued denial of the controlled
168 substance license.
169 (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and
170 inventories in conformance with the record keeping and inventory requirements of federal and
171 state law and any additional rules issued by the division.
172 (b) (i) Every physician, dentist, naturopathic physician, veterinarian, practitioner, or
173 other person who is authorized to administer or professionally use a controlled substance shall
174 keep a record of the drugs received by him and a record of all drugs administered, dispensed, or
175 professionally used by him otherwise than by a prescription.
176 (ii) A person using small quantities or solutions or other preparations of those drugs for
177 local application has complied with this Subsection (5)(b) if the person keeps a record of the
178 quantity, character, and potency of those solutions or preparations purchased or prepared by
179 him, and of the dates when purchased or prepared.
180 (6) Controlled substances in Schedules I through V may be distributed only by a
181 licensee and pursuant to an order form prepared in compliance with division rules or a lawful
182 order under the rules and regulations of the United States.
183 (7) (a) A person may not write or authorize a prescription for a controlled substance
184 unless the person is:
185 (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
186 or under the laws of another state having similar standards; and
187 (ii) licensed under this chapter or under the laws of another state having similar
188 standards.
189 (b) A person other than a pharmacist licensed under the laws of this state, or the
190 pharmacist's licensed intern, as required by Sections 58-17b-303 and 58-17b-304 , may not
191 dispense a controlled substance.
192 (c) (i) A controlled substance may not be dispensed without the written prescription of
193 a practitioner, if the written prescription is required by the federal Controlled Substances Act.
194 (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
195 conformity with Subsection (7)(d).
196 (iii) In emergency situations, as defined by division rule, controlled substances may be
197 dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
198 designated by the division and filed by the pharmacy.
199 (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
200 Subsection (7)(d).
201 (d) Except for emergency situations designated by the division, a person may not issue,
202 fill, compound, or dispense a prescription for a controlled substance unless the prescription is
203 signed by the prescriber in ink or indelible pencil or is signed with an electronic signature of
204 the prescriber as authorized by division rule, and contains the following information:
205 (i) the name, address, and registry number of the prescriber;
206 (ii) the name, address, and age of the person to whom or for whom the prescription is
207 issued;
208 (iii) the date of issuance of the prescription; and
209 (iv) the name, quantity, and specific directions for use by the ultimate user of the
210 controlled substance.
211 (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
212 controlled substance unless:
213 (i) the person who writes the prescription is licensed under Subsection (2); and
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 II substance may not be refilled.
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-month's supply, as directed on the daily dosage rate of the prescriptions.
220 (ii) A Schedule III 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 prescriber's
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 II 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 II controlled substance, but only under the following conditions:
233 (A) no more than three prescriptions for the same Schedule II 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.
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244 (g) An order for a controlled substance in Schedules II through V for use by an
245 inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
246 Subsection (7) if the order is:
247 (i) issued or made by a prescribing practitioner who holds an unrestricted registration
248 with the federal Drug Enforcement Administration, and an active Utah controlled substance
249 license in good standing issued by the division under this section, or a medical resident who is
250 exempted from licensure under Subsection 58-1-307 (1)(c);
251 (ii) authorized by the prescribing practitioner treating the patient and the prescribing
252 practitioner designates the quantity ordered;
253 (iii) entered upon the record of the patient, the record is signed by the prescriber
254 affirming the prescriber's authorization of the order within 48 hours after filling or
255 administering the order, and the patient's record reflects the quantity actually administered; and
256 (iv) filled and dispensed by a pharmacist practicing the pharmacist's profession within
257 the physical structure of the hospital, or the order is taken from a supply lawfully maintained by
258 the hospital and the amount taken from the supply is administered directly to the patient
259 authorized to receive it.
260 (h) A practitioner licensed under this chapter may not prescribe, administer, or
261 dispense a controlled substance to a child, without first obtaining the consent required in
262 Section 78B-3-406 of a parent, guardian, or person standing in loco parentis of the child except
263 in cases of an emergency. For purposes of this Subsection (7)(h), "child" has the same
264 meaning as defined in Section 78A-6-105 , and "emergency" means any physical condition
265 requiring the administration of a controlled substance for immediate relief of pain or suffering.
266 (i) A practitioner licensed under this chapter may not prescribe or administer dosages
267 of a controlled substance in excess of medically recognized quantities necessary to treat the
268 ailment, malady, or condition of the ultimate user.
269 (j) A practitioner licensed under this chapter may not prescribe, administer, or dispense
270 any controlled substance to another person knowing that the other person is using a false name,
271 address, or other personal information for the purpose of securing the controlled substance.
272 (k) A person who is licensed under this chapter to manufacture, distribute, or dispense
273 a controlled substance may not manufacture, distribute, or dispense a controlled substance to
274 another licensee or any other authorized person not authorized by this license.
275 (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a
276 symbol required by this chapter or by a rule issued under this chapter.
277 (m) A person licensed under this chapter may not refuse or fail to make, keep, or
278 furnish any record notification, order form, statement, invoice, or information required under
279 this chapter.
280 (n) A person licensed under this chapter may not refuse entry into any premises for
281 inspection as authorized by this chapter.
282 (o) A person licensed under this chapter may not furnish false or fraudulent material
283 information in any application, report, or other document required to be kept by this chapter or
284 willfully make any false statement in any prescription, order, report, or record required by this
285 chapter.
286 (8) (a) (i) Any person licensed under this chapter who is found by the division to have
287 violated any of the provisions of Subsections (7)(k) through (o) or Subsection (10) is subject to
288 a penalty not to exceed $5,000. The division shall determine the procedure for adjudication of
289 any violations in accordance with Sections 58-1-106 and 58-1-108 .
290 (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in the
291 General Fund as a dedicated credit to be used by the division under Subsection 58-37f-502 (1).
292 (b) Any person who knowingly and intentionally violates Subsections (7)(h) through (j)
293 or Subsection (10) is:
294 (i) upon first conviction, guilty of a class B misdemeanor;
295 (ii) upon second conviction, guilty of a class A misdemeanor; and
296 (iii) on third or subsequent conviction, guilty of a third degree felony.
297 (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
298 (o) shall upon conviction be guilty of a third degree felony.
299 (9) Any information communicated to any licensed practitioner in an attempt to
300 unlawfully procure, or to procure the administration of, a controlled substance is not considered
301 to be a privileged communication.
302 (10) A person holding a valid license under this chapter who is engaged in medical
303 research may produce, possess, administer, prescribe, or dispense a controlled substance for
304 research purposes as licensed under Subsection (2) but may not otherwise prescribe or dispense
305 a controlled substance listed in Section 58-37-4.2 .
Legislative Review Note
as of 2-4-14 10:18 AM