S.B. 104

1

PRESCRIBING PRACTICES FOR SCHEDULE
2 II DRUGS
3 2006 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor: Peter C. Knudson
6 House Sponsor: ____________
7
8 LONG TITLE
9 General Description:
10 This bill amends the Utah Controlled Substances Act to comply with changes in rules
11 adopted by the Federal Drug Enforcement Administration, and amends the number of
12 day's supply of a Schedule II drug that may be prescribed.
13 Highlighted Provisions:
14 This bill:
15 . changes the number of day's supply of a Schedule II drug that may be prescribed
16 from a 30 day's supply to a 90 day's supply; and
17 . removes the provision from the law that permits a practitioner to issue at one time,
18 up to three postdated prescriptions for a Schedule II drug.
19 Monies Appropriated in this Bill:
20 None
21 Other Special Clauses:
22 None
23 Utah Code Sections Affected:
24 AMENDS:
25 58-37-6, as last amended by Chapter 248, Laws of Utah 2005
26
27 Be it enacted by the Legislature of the state of Utah:

28 Section 1. Section 58-37-6 is amended to read:
29 58-37-6. License to manufacture, produce, distribute, dispense, administer, or
30 conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records
31 required -- Prescriptions.
32 (1) (a) The division may adopt rules relating to the licensing and control of the
33 manufacture, distribution, production, prescription, administration, dispensing, conducting of
34 research with, and performing of laboratory analysis upon controlled substances within this
35 state.
36 (b) The division may assess reasonable fees to defray the cost of issuing original and
37 renewal licenses under this chapter pursuant to Section 63-38-3.2 .
38 (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
39 administers, conducts research with, or performs laboratory analysis upon any controlled
40 substance in Schedules II through V within this state, or who proposes to engage in
41 manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
42 research with, or performing laboratory analysis upon controlled substances included in
43 Schedules II through V within this state shall obtain a license issued by the division.
44 (ii) The division shall issue each license under this chapter in accordance with a
45 two-year renewal cycle established by rule. The division may by rule extend or shorten a
46 renewal period by as much as one year to stagger the renewal cycles it administers.
47 (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
48 administer, conduct research with, or perform laboratory analysis upon controlled substances in
49 Schedules II through V within this state may possess, manufacture, produce, distribute,
50 prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
51 those substances to the extent authorized by their license and in conformity with this chapter.
52 (c) The following persons are not required to obtain a license and may lawfully possess
53 controlled substances under this section:
54 (i) an agent or employee, except a sales representative, of any registered manufacturer,
55 distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
56 usual course of his business or employment; however, nothing in this subsection shall be
57 interpreted to permit an agent, employee, sales representative, or detail man to maintain an
58 inventory of controlled substances separate from the location of his employer's registered and

59 licensed place of business;
60 (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
61 warehouseman, who possesses any controlled substance in the usual course of his business or
62 employment; and
63 (iii) an ultimate user, or any person who possesses any controlled substance pursuant to
64 a lawful order of a practitioner.
65 (d) The division may enact rules waiving the license requirement for certain
66 manufacturers, producers, distributors, prescribers, dispensers, administrators, research
67 practitioners, or laboratories performing analysis if consistent with the public health and safety.
68 (e) A separate license is required at each principal place of business or professional
69 practice where the applicant manufactures, produces, distributes, dispenses, conducts research
70 with, or performs laboratory analysis upon controlled substances.
71 (f) The division may enact rules providing for the inspection of a licensee or applicant's
72 establishment, and may inspect the establishment according to those rules.
73 (3) (a) Upon proper application, the division shall license a qualified applicant to
74 manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
75 controlled substances included in Schedules I through V, unless it determines that issuance of a
76 license is inconsistent with the public interest. The division shall not issue a license to any
77 person to prescribe, dispense, or administer a Schedule I controlled substance. In determining
78 public interest, the division shall consider whether or not the applicant has:
79 (i) maintained effective controls against diversion of controlled substances and any
80 Schedule I or II substance compounded from any controlled substance into other than
81 legitimate medical, scientific, or industrial channels;
82 (ii) complied with applicable state and local law;
83 (iii) been convicted under federal or state laws relating to the manufacture, distribution,
84 or dispensing of substances;
85 (iv) past experience in the manufacture of controlled dangerous substances;
86 (v) established effective controls against diversion; and
87 (vi) complied with any other factors that the division establishes that promote the
88 public health and safety.
89 (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,

90 produce, distribute, conduct research with, or perform laboratory analysis upon controlled
91 substances in Schedule I other than those specified in the license.
92 (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
93 substances in Schedules II through V if they are authorized to administer, dispense, or conduct
94 research under the laws of this state.
95 (ii) The division need not require a separate license for practitioners engaging in
96 research with nonnarcotic controlled substances in Schedules II through V where the licensee is
97 already licensed under this act in another capacity.
98 (iii) With respect to research involving narcotic substances in Schedules II through V,
99 or where the division by rule requires a separate license for research of nonnarcotic substances
100 in Schedules II through V, a practitioner shall apply to the division prior to conducting
101 research.
102 (iv) Licensing for purposes of bona fide research with controlled substances by a
103 practitioner considered qualified may be denied only on a ground specified in Subsection (4),
104 or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
105 adequately his supply of substances against diversion from medical or scientific use.
106 (v) Practitioners registered under federal law to conduct research in Schedule I
107 substances may conduct research in Schedule I substances within this state upon furnishing the
108 division evidence of federal registration.
109 (d) Compliance by manufacturers, producers, and distributors with the provisions of
110 federal law respecting registration, excluding fees, entitles them to be licensed under this
111 chapter.
112 (e) The division shall initially license those persons who own or operate an
113 establishment engaged in the manufacture, production, distribution, dispensation, or
114 administration of controlled substances prior to April 3, 1980, and who are licensed by the
115 state.
116 (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed
117 on probation, or revoked by the division upon finding that the applicant or licensee has:
118 (i) materially falsified any application filed or required pursuant to this chapter;
119 (ii) been convicted of an offense under this chapter or any law of the United States, or
120 any state, relating to any substance defined as a controlled substance;

121 (iii) been convicted of a felony under any other law of the United States or any state
122 within five years of the date of the issuance of the license;
123 (iv) had a federal license denied, suspended, or revoked by competent federal authority
124 and is no longer authorized to engage in the manufacturing, distribution, or dispensing of
125 controlled substances;
126 (v) had his license suspended or revoked by competent authority of another state for
127 violation of laws or regulations comparable to those of this state relating to the manufacture,
128 distribution, or dispensing of controlled substances;
129 (vi) violated any division rule that reflects adversely on the licensee's reliability and
130 integrity with respect to controlled substances;
131 (vii) refused inspection of records required to be maintained under this chapter by a
132 person authorized to inspect them; or
133 (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
134 purpose of manipulating human hormonal structure so as to:
135 (A) increase muscle mass, strength, or weight without medical necessity and without a
136 written prescription by any practitioner in the course of his professional practice; or
137 (B) improve performance in any form of human exercise, sport, or game.
138 (b) The division may limit revocation or suspension of a license to a particular
139 controlled substance with respect to which grounds for revocation or suspension exist.
140 (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to
141 this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
142 Occupational and Professional Licensing Act, and conducted in conjunction with the
143 appropriate representative committee designated by the director of the department.
144 (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
145 Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
146 except where the division is designated by law to perform those functions, or, when not
147 designated by law, is designated by the executive director of the Department of Commerce to
148 conduct the proceedings.
149 (d) (i) The division may suspend any license simultaneously with the institution of
150 proceedings under this section if it finds there is an imminent danger to the public health or
151 safety.

152 (ii) Suspension shall continue in effect until the conclusion of proceedings, including
153 judicial review, unless withdrawn by the division or dissolved by a court of competent
154 jurisdiction.
155 (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
156 substances owned or possessed by the licensee may be placed under seal in the discretion of the
157 division.
158 (ii) Disposition may not be made of substances under seal until the time for taking an
159 appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
160 orders the sale of perishable substances and the proceeds deposited with the court.
161 (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
162 (f) The division shall notify promptly the Drug Enforcement Administration of all
163 orders suspending or revoking a license and all forfeitures of controlled substances.
164 (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and
165 inventories in conformance with the record keeping and inventory requirements of federal and
166 state law and any additional rules issued by the division.
167 (b) (i) Every physician, dentist, veterinarian, practitioner, or other person who is
168 authorized to administer or professionally use a controlled substance shall keep a record of the
169 drugs received by him and a record of all drugs administered, dispensed, or professionally used
170 by him otherwise than by a prescription.
171 (ii) A person using small quantities or solutions or other preparations of those drugs for
172 local application has complied with this Subsection (5)(b) if he keeps a record of the quantity,
173 character, and potency of those solutions or preparations purchased or prepared by him, and of
174 the dates when purchased or prepared.
175 (6) Controlled substances in Schedules I through V may be distributed only by a
176 licensee and pursuant to an order form prepared in compliance with division rules or a lawful
177 order under the rules and regulations of the United States.
178 (7) (a) A person may not write or authorize a prescription for a controlled substance
179 unless he is:
180 (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
181 or under the laws of another state having similar standards; and
182 (ii) licensed under this chapter or under the laws of another state having similar

183 standards.
184 (b) A person other than a pharmacist licensed under the laws of this state, or his
185 licensed intern, as required by Sections 58-17b-303 and 58-17b-304 , may not dispense a
186 controlled substance.
187 (c) (i) A controlled substance may not be dispensed without the written prescription of
188 a practitioner, if the written prescription is required by the federal Controlled Substances Act.
189 (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
190 conformity with Subsection (7)(d).
191 (iii) In emergency situations, as defined by division rule, controlled substances may be
192 dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
193 designated by the division and filed by the pharmacy.
194 (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
195 Subsection (7)(d).
196 (d) Except for emergency situations designated by the division, a person may not issue,
197 fill, compound, or dispense a prescription for a controlled substance unless the prescription is
198 signed by the prescriber in ink or indelible pencil or is signed with an electronic or digital
199 signature of the prescriber as authorized by division rule, and contains the following
200 information:
201 (i) the name, address, and registry number of the prescriber;
202 (ii) the name, address, and age of the person to whom or for whom the prescription is
203 issued;
204 (iii) the date of issuance of the prescription; and
205 (iv) the name, quantity, and specific directions for use by the ultimate user of the
206 controlled substance.
207 (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
208 controlled substance.
209 (f) Except when administered directly to an ultimate user by a licensed practitioner,
210 controlled substances are subject to the following restrictions:
211 (i) (A) A prescription for a Schedule II substance may not be refilled.
212 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
213 [one-month's] 90 day supply, as directed on the daily dosage rate of the prescriptions.

214 (ii) A Schedule III or IV controlled substance may be filled only within six months of
215 issuance, and may not be refilled more than six months after the date of its original issuance or
216 be refilled more than five times after the date of the prescription unless renewed by the
217 practitioner.
218 (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
219 prescription directs, but they may not be refilled one year after the date the prescription was
220 issued unless renewed by the practitioner.
221 (iv) Any prescription for a Schedule II substance may not be dispensed if it is not
222 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
223 after the date the prescription was issued, or 30 days after the dispensing date, if that date is
224 specified separately from the date of issue.
225 (v) A practitioner may not issue more than one prescription at the same time for the
226 same Schedule II controlled substance[, but only under the following conditions:].
227 [(A) no more than three prescriptions for the same Schedule II controlled substance
228 may be issued at the same time;]
229 [(B) no one prescription may exceed a 30-day supply;]
230 [(C) a second or third prescription shall include the date of issuance and the date for
231 dispensing; and]
232 [(D) unless the practitioner determines there is a valid medical reason to the contrary,
233 the date for dispensing a second or third prescription may not be fewer than 30 days from the
234 dispensing date of the previous prescription.]
235 (vi) Each prescription for a controlled substance may contain only one controlled
236 substance per prescription form and may not contain any other legend drug or prescription
237 item.
238 (g) An order for a controlled substance in Schedules II through V for use by an
239 inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
240 Subsection (7) if the order is:
241 (i) issued or made by a prescribing practitioner who holds an unrestricted registration
242 with the federal Drug Enforcement Administration, and an active Utah controlled substance
243 license in good standing issued by the division under this section, or a medical resident who is
244 exempted from licensure under Subsection 58-1-307 (1)(c);

245 (ii) authorized by the prescribing practitioner treating the patient and the prescribing
246 practitioner designates the quantity ordered;
247 (iii) entered upon the record of the patient, the record is signed by the prescriber
248 affirming his authorization of the order within 48 hours after filling or administering the order,
249 and the patient's record reflects the quantity actually administered; and
250 (iv) filled and dispensed by a pharmacist practicing his profession within the physical
251 structure of the hospital, or the order is taken from a supply lawfully maintained by the hospital
252 and the amount taken from the supply is administered directly to the patient authorized to
253 receive it.
254 (h) A practitioner licensed under this chapter may not prescribe, administer, or
255 dispense a controlled substance to a minor, without first obtaining the consent required in
256 Section 78-14-5 of a parent, guardian, or person standing in loco parentis of the minor except
257 in cases of an emergency. For purposes of this Subsection (7)(h), "minor" has the same
258 meaning as defined in Section 78-3a-103 , and "emergency" means any physical condition
259 requiring the administration of a controlled substance for immediate relief of pain or suffering.
260 (i) A practitioner licensed under this chapter may not prescribe or administer dosages
261 of a controlled substance in excess of medically recognized quantities necessary to treat the
262 ailment, malady, or condition of the ultimate user.
263 (j) A practitioner licensed under this chapter may not prescribe, administer, or dispense
264 any controlled substance to another person knowing that the other person is using a false name,
265 address, or other personal information for the purpose of securing the controlled substance.
266 (k) A person who is licensed under this chapter to manufacture, distribute, or dispense
267 a controlled substance may not manufacture, distribute, or dispense a controlled substance to
268 another licensee or any other authorized person not authorized by this license.
269 (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a
270 symbol required by this chapter or by a rule issued under this chapter.
271 (m) A person licensed under this chapter may not refuse or fail to make, keep, or
272 furnish any record notification, order form, statement, invoice, or information required under
273 this chapter.
274 (n) A person licensed under this chapter may not refuse entry into any premises for
275 inspection as authorized by this chapter.

276 (o) A person licensed under this chapter may not furnish false or fraudulent material
277 information in any application, report, or other document required to be kept by this chapter or
278 willfully make any false statement in any prescription, order, report, or record required by this
279 chapter.
280 (8) (a) (i) Any person licensed under this chapter who is found by the division to have
281 violated any of the provisions of Subsections (7)(k) through (7)(o) is subject to a penalty not to
282 exceed $5,000. The division shall determine the procedure for adjudication of any violations in
283 accordance with Sections 58-1-106 and 58-1-108 .
284 (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in the
285 General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
286 (b) Any person who knowingly and intentionally violates Subsections (7)(h) through
287 (7)(j) is:
288 (i) upon first conviction, guilty of a class B misdemeanor;
289 (ii) upon second conviction, guilty of a class A misdemeanor; and
290 (iii) on third or subsequent conviction, guilty of a third degree felony.
291 (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
292 (7)(o) shall upon conviction be guilty of a third degree felony.
293 (9) Any information communicated to any licensed practitioner in an attempt to
294 unlawfully procure, or to procure the administration of, a controlled substance is not considered
295 to be a privileged communication.




Legislative Review Note
as of 11-2-05 3:06 PM

Based on a limited legal review, this legislation has not been determined to have a high
probability of being held unconstitutional.

Office of Legislative Research and General Counsel