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H.B. 108 Enrolled
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7 LONG TITLE
8 General Description:
9 This bill amends the Utah Controlled Substances Act and the Naturopathic Physician
10 Practice Act to permit a naturopathic physician to, pursuant to a license issued by the
11 Division of Occupational and Professional Licensing, prescribe or administer
12 testosterone in specified forms for the purpose of restoring a low testosterone level to a
13 normal level.
14 Highlighted Provisions:
15 This bill:
16 . adds "naturopathic physician" to the definition of "practitioner" in the Utah
17 Controlled Substances Act in order to allow a naturopathic physician to prescribe
18 only testosterone, in the form and for the purposes described in this bill;
19 . requires a naturopathic physician to keep a record of testosterone:
20 . received by the naturopathic physician; and
21 . administered, dispensed, or professionally used by the naturopathic physician,
22 other than by a prescription;
23 . permits a naturopathic physician to prescribe or administer testosterone, pursuant
24 to the requirements of federal and state law, if the testosterone is:
25 . bio-identical;
26 . designed to be administered topically, for transdermal absorption or
27 designed to be absorbed across the mucosal membranes of the mouth; and
28 . prescribed solely for the purpose of treating a patient with a low testosterone
29 level in order to restore the patient to a normal testosterone level;
30 . provides that the provisions of Title 58, Chapter 71, Naturopathic Physician
31 Practice Act, do not mandate health insurance coverage for the prescription or
32 administration of testosterone by a naturopathic physician; and
33 . makes technical changes.
34 Monies Appropriated in this Bill:
35 None
36 Other Special Clauses:
37 None
38 Utah Code Sections Affected:
39 AMENDS:
40 58-37-2, as last amended by Laws of Utah 2008, Chapter 382
41 58-37-6, as last amended by Laws of Utah 2008, Chapters 3 and 382
42 58-71-102, as last amended by Laws of Utah 2008, Chapter 382
43 58-71-804, as enacted by Laws of Utah 1996, Chapter 282
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45 Be it enacted by the Legislature of the state of Utah:
46 Section 1. Section 58-37-2 is amended to read:
47 58-37-2. Definitions.
48 (1) As used in this chapter:
49 (a) "Administer" means the direct application of a controlled substance, whether by
50 injection, inhalation, ingestion, or any other means, to the body of a patient or research subject
51 by:
52 (i) a practitioner or, in the practitioner's presence, by the practitioner's authorized
53 agent; or
54 (ii) the patient or research subject at the direction and in the presence of the
55 practitioner.
56 (b) "Agent" means an authorized person who acts on behalf of or at the direction of a
57 manufacturer, distributor, or practitioner but does not include a motor carrier, public
58 warehouseman, or employee of any of them.
59 (c) "Consumption" means ingesting or having any measurable amount of a controlled
60 substance in a person's body, but this Subsection (1)(c) does not include the metabolite of a
61 controlled substance.
62 (d) "Continuing criminal enterprise" means any individual, sole proprietorship,
63 partnership, corporation, business trust, association, or other legal entity, and any union or
64 groups of individuals associated in fact although not a legal entity, and includes illicit as well
65 as licit entities created or maintained for the purpose of engaging in conduct which constitutes
66 the commission of episodes of activity made unlawful by Title 58, Chapters 37, 37a, 37b, 37c,
67 or 37d, which episodes are not isolated, but have the same or similar purposes, results,
68 participants, victims, methods of commission, or otherwise are interrelated by distinguishing
69 characteristics. Taken together, the episodes shall demonstrate continuing unlawful conduct
70 and be related either to each other or to the enterprise.
71 (e) "Control" means to add, remove, or change the placement of a drug, substance, or
72 immediate precursor under Section 58-37-3 .
73 (f) (i) "Controlled substance" means a drug or substance included in Schedules I, II,
74 III, IV, or V of Section 58-37-4 , and also includes a drug or substance included in Schedules I,
75 II, III, IV, or V of the federal Controlled Substances Act, Title II, P.L. 91-513, or any
76 controlled substance analog.
77 (ii) "Controlled substance" does not include:
78 (A) distilled spirits, wine, or malt beverages, as those terms are defined or used in Title
79 32A, Alcoholic Beverage Control Act, regarding tobacco or food;
80 (B) any drug intended for lawful use in the diagnosis, cure, mitigation, treatment, or
81 prevention of disease in man or other animals, which contains ephedrine, pseudoephedrine,
82 norpseudoephedrine, or phenylpropanolamine if the drug is lawfully purchased, sold,
83 transferred, or furnished as an over-the-counter medication without prescription; or
84 (C) dietary supplements, vitamins, minerals, herbs, or other similar substances
85 including concentrates or extracts, which are not otherwise regulated by law, which may
86 contain naturally occurring amounts of chemical or substances listed in this chapter, or in rules
87 adopted pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
88 (g) (i) "Controlled substance analog" means a substance the chemical structure of
89 which is substantially similar to the chemical structure of a controlled substance listed in
90 Schedules I and II of Section 58-37-4 , or in Schedules I and II of the federal Controlled
91 Substances Act, Title II, P.L. 91-513:
92 (A) which has a stimulant, depressant, or hallucinogenic effect on the central nervous
93 system substantially similar to the stimulant, depressant, or hallucinogenic effect on the central
94 nervous system of controlled substances in the schedules set forth in Subsection (1)(f); or
95 (B) which, with respect to a particular individual, is represented or intended to have a
96 stimulant, depressant, or hallucinogenic effect on the central nervous system substantially
97 similar to the stimulant, depressant, or hallucinogenic effect on the central nervous system of
98 controlled substances in the schedules set forth in this Subsection (1).
99 (ii) "Controlled substance analog" does not include:
100 (A) a controlled substance currently scheduled in Schedules I through V of Section
101 58-37-4 ;
102 (B) a substance for which there is an approved new drug application;
103 (C) a substance with respect to which an exemption is in effect for investigational use
104 by a particular person under Section 505 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 355,
105 to the extent the conduct with respect to the substance is permitted by the exemption;
106 (D) any substance to the extent not intended for human consumption before an
107 exemption takes effect with respect to the substance;
108 (E) any drug intended for lawful use in the diagnosis, cure, mitigation, treatment, or
109 prevention of disease in man or other animals, which contains ephedrine, pseudoephedrine,
110 norpseudoephedrine, or phenylpropanolamine if the drug is lawfully purchased, sold,
111 transferred, or furnished as an over-the-counter medication without prescription; or
112 (F) dietary supplements, vitamins, minerals, herbs, or other similar substances
113 including concentrates or extracts, which are not otherwise regulated by law, which may
114 contain naturally occurring amounts of chemical or substances listed in this chapter, or in rules
115 adopted pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
116 (h) "Conviction" means a determination of guilt by verdict, whether jury or bench, or
117 plea, whether guilty or no contest, for any offense proscribed by Title 58, Chapters 37, 37a,
118 37b, 37c, or 37d, or for any offense under the laws of the United States and any other state
119 which, if committed in this state, would be an offense under Title 58, Chapters 37, 37a, 37b,
120 37c, or 37d.
121 (i) "Counterfeit substance" means:
122 (i) any substance or container or labeling of any substance that without authorization
123 bears the trademark, trade name, or other identifying mark, imprint, number, device, or any
124 likeness of them, of a manufacturer, distributor, or dispenser other than the person or persons
125 who in fact manufactured, distributed, or dispensed the substance which falsely purports to be
126 a controlled substance distributed by, any other manufacturer, distributor, or dispenser; or
127 (ii) any substance that is represented to be a controlled substance.
128 (j) "Deliver" or "delivery" means the actual, constructive, or attempted transfer of a
129 controlled substance or a listed chemical, whether or not an agency relationship exists.
130 (k) "Department" means the Department of Commerce.
131 (l) "Depressant or stimulant substance" means:
132 (i) a drug which contains any quantity of barbituric acid or any of the salts of
133 barbituric acid;
134 (ii) a drug which contains any quantity of:
135 (A) amphetamine or any of its optical isomers;
136 (B) any salt of amphetamine or any salt of an optical isomer of amphetamine; or
137 (C) any substance which the Secretary of Health and Human Services or the Attorney
138 General of the United States after investigation has found and by regulation designated
139 habit-forming because of its stimulant effect on the central nervous system;
140 (iii) lysergic acid diethylamide; or
141 (iv) any drug which contains any quantity of a substance which the Secretary of
142 Health and Human Services or the Attorney General of the United States after investigation
143 has found to have, and by regulation designated as having, a potential for abuse because of its
144 depressant or stimulant effect on the central nervous system or its hallucinogenic effect.
145 (m) "Dispense" means the delivery of a controlled substance by a pharmacist to an
146 ultimate user pursuant to the lawful order or prescription of a practitioner, and includes
147 distributing to, leaving with, giving away, or disposing of that substance as well as the
148 packaging, labeling, or compounding necessary to prepare the substance for delivery.
149 (n) "Dispenser" means a pharmacist who dispenses a controlled substance.
150 (o) "Distribute" means to deliver other than by administering or dispensing a
151 controlled substance or a listed chemical.
152 (p) "Distributor" means a person who distributes controlled substances.
153 (q) "Division" means the Division of Occupational and Professional Licensing created
154 in Section 58-1-103 .
155 (r) "Drug" means:
156 (i) articles recognized in the official United States Pharmacopoeia, Official
157 Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
158 supplement to any of them;
159 (ii) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention
160 of disease in man or other animals;
161 (iii) articles, other than food, intended to affect the structure or function of man or
162 other animals; and
163 (iv) articles intended for use as a component of any articles specified in Subsection
164 (1)(r)(i), (ii), or (iii); but does not include devices or their components, parts, or accessories.
165 (s) "Drug dependent person" means any individual who unlawfully and habitually uses
166 any controlled substance to endanger the public morals, health, safety, or welfare, or who is so
167 dependent upon the use of controlled substances as to have lost the power of self-control with
168 reference to the individual's dependency.
169 (t) "Food" means:
170 (i) any nutrient or substance of plant, mineral, or animal origin other than a drug as
171 specified in this chapter, and normally ingested by human beings; and
172 (ii) foods for special dietary uses as exist by reason of a physical, physiological,
173 pathological, or other condition including but not limited to the conditions of disease,
174 convalescence, pregnancy, lactation, allergy, hypersensitivity to food, underweight, and
175 overweight; uses for supplying a particular dietary need which exist by reason of age including
176 but not limited to the ages of infancy and childbirth, and also uses for supplementing and for
177 fortifying the ordinary or unusual diet with any vitamin, mineral, or other dietary property for
178 use of a food. Any particular use of a food is a special dietary use regardless of the nutritional
179 purposes.
180 (u) "Immediate precursor" means a substance which the Attorney General of the
181 United States has found to be, and by regulation designated as being, the principal compound
182 used or produced primarily for use in the manufacture of a controlled substance, or which is an
183 immediate chemical intermediary used or likely to be used in the manufacture of a controlled
184 substance, the control of which is necessary to prevent, curtail, or limit the manufacture of the
185 controlled substance.
186 (v) "Indian" means a member of an Indian tribe.
187 (w) "Indian religion" means any religion:
188 (i) the origin and interpretation of which is from within a traditional Indian culture or
189 community; and
190 (ii) which is practiced by Indians.
191 (x) "Indian tribe" means any tribe, band, nation, pueblo, or other organized group or
192 community of Indians, including any Alaska Native village, which is legally recognized as
193 eligible for and is consistent with the special programs, services, and entitlements provided by
194 the United States to Indians because of their status as Indians.
195 (y) "Manufacture" means the production, preparation, propagation, compounding, or
196 processing of a controlled substance, either directly or indirectly by extraction from substances
197 of natural origin, or independently by means of chemical synthesis or by a combination of
198 extraction and chemical synthesis.
199 (z) "Manufacturer" includes any person who packages, repackages, or labels any
200 container of any controlled substance, except pharmacists who dispense or compound
201 prescription orders for delivery to the ultimate consumer.
202 (aa) "Marijuana" means all species of the genus cannabis and all parts of the genus,
203 whether growing or not; the seeds of it; the resin extracted from any part of the plant; and
204 every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds,
205 or resin. The term does not include the mature stalks of the plant, fiber produced from the
206 stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt,
207 derivative, mixture, or preparation of the mature stalks, except the resin extracted from them,
208 fiber, oil or cake, or the sterilized seed of the plant which is incapable of germination. Any
209 synthetic equivalents of the substances contained in the plant cannabis sativa or any other
210 species of the genus cannabis which are chemically indistinguishable and pharmacologically
211 active are also included.
212 (bb) "Money" means officially issued coin and currency of the United States or any
213 foreign country.
214 (cc) "Narcotic drug" means any of the following, whether produced directly or
215 indirectly by extraction from substances of vegetable origin, or independently by means of
216 chemical synthesis, or by a combination of extraction and chemical synthesis:
217 (i) opium, coca leaves, and opiates;
218 (ii) a compound, manufacture, salt, derivative, or preparation of opium, coca leaves, or
219 opiates;
220 (iii) opium poppy and poppy straw; or
221 (iv) a substance, and any compound, manufacture, salt, derivative, or preparation of
222 the substance, which is chemically identical with any of the substances referred to in
223 Subsection (1)(cc)(i), (ii), or (iii), except narcotic drug does not include decocainized coca
224 leaves or extracts of coca leaves which do not contain cocaine or ecgonine.
225 (dd) "Negotiable instrument" means documents, containing an unconditional promise
226 to pay a sum of money, which are legally transferable to another party by endorsement or
227 delivery.
228 (ee) "Opiate" means any drug or other substance having an addiction-forming or
229 addiction-sustaining liability similar to morphine or being capable of conversion into a drug
230 having addiction-forming or addiction-sustaining liability.
231 (ff) "Opium poppy" means the plant of the species papaver somniferum L., except the
232 seeds of the plant.
233 (gg) "Person" means any corporation, association, partnership, trust, other institution
234 or entity or one or more individuals.
235 (hh) "Poppy straw" means all parts, except the seeds, of the opium poppy, after
236 mowing.
237 (ii) "Possession" or "use" means the joint or individual ownership, control, occupancy,
238 holding, retaining, belonging, maintaining, or the application, inhalation, swallowing,
239 injection, or consumption, as distinguished from distribution, of controlled substances and
240 includes individual, joint, or group possession or use of controlled substances. For a person to
241 be a possessor or user of a controlled substance, it is not required that the person be shown to
242 have individually possessed, used, or controlled the substance, but it is sufficient if it is shown
243 that the person jointly participated with one or more persons in the use, possession, or control
244 of any substances with knowledge that the activity was occurring, or the controlled substance
245 is found in a place or under circumstances indicating that the person had the ability and the
246 intent to exercise dominion and control over it.
247 (jj) "Practitioner" means a physician, dentist, naturopathic physician, veterinarian,
248 pharmacist, scientific investigator, pharmacy, hospital, or other person licensed, registered, or
249 otherwise permitted to distribute, dispense, conduct research with respect to, administer, or
250 use in teaching or chemical analysis a controlled substance in the course of professional
251 practice or research in this state.
252 (kk) "Prescribe" means to issue a prescription orally or in writing.
253 (ll) "Prescription" means an order issued by a licensed practitioner, in the course of
254 that practitioner's professional practice, for a controlled substance, other drug, or device which
255 it dispenses or administers for use by a patient or an animal. The order may be issued by word
256 of mouth, written document, telephone, facsimile transmission, computer, or other electronic
257 means of communication as defined by rule.
258 (mm) "Production" means the manufacture, planting, cultivation, growing, or
259 harvesting of a controlled substance.
260 (nn) "Securities" means any stocks, bonds, notes, or other evidences of debt or of
261 property.
262 (oo) "State" means the state of Utah.
263 (pp) "Ultimate user" means any person who lawfully possesses a controlled substance
264 for the person's own use, for the use of a member of the person's household, or for
265 administration to an animal owned by the person or a member of the person's household.
266 (2) If a term used in this chapter is not defined, the definition and terms of Title 76,
267 Utah Criminal Code, shall apply.
268 Section 2. Section 58-37-6 is amended to read:
269 58-37-6. License to manufacture, produce, distribute, dispense, administer, or
270 conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records
271 required -- Prescriptions.
272 (1) (a) The division may adopt rules relating to the licensing and control of the
273 manufacture, distribution, production, prescription, administration, dispensing, conducting of
274 research with, and performing of laboratory analysis upon controlled substances within this
275 state.
276 (b) The division may assess reasonable fees to defray the cost of issuing original and
277 renewal licenses under this chapter pursuant to Section 63J-1-303 .
278 (2) (a) (i) Every person who manufactures, produces, distributes, prescribes,
279 dispenses, administers, conducts research with, or performs laboratory analysis upon any
280 controlled substance in Schedules II through V within this state, or who proposes to engage in
281 manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
282 research with, or performing laboratory analysis upon controlled substances included in
283 Schedules II through V within this state shall obtain a license issued by the division.
284 (ii) The division shall issue each license under this chapter in accordance with a
285 two-year renewal cycle established by rule. The division may by rule extend or shorten a
286 renewal period by as much as one year to stagger the renewal cycles it administers.
287 (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
288 administer, conduct research with, or perform laboratory analysis upon controlled substances
289 in Schedules II through V within this state may possess, manufacture, produce, distribute,
290 prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
291 those substances to the extent authorized by their license and in conformity with this chapter.
292 (c) The following persons are not required to obtain a license and may lawfully
293 possess controlled substances under this section:
294 (i) an agent or employee, except a sales representative, of any registered manufacturer,
295 distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
296 usual course of the person's business or employment; however, nothing in this subsection shall
297 be interpreted to permit an agent, employee, sales representative, or detail man to maintain an
298 inventory of controlled substances separate from the location of the person's employer's
299 registered and licensed place of business;
300 (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
301 warehouseman, who possesses any controlled substance in the usual course of the person's
302 business or employment; and
303 (iii) an ultimate user, or any person who possesses any controlled substance pursuant
304 to a lawful order of a practitioner.
305 (d) The division may enact rules waiving the license requirement for certain
306 manufacturers, producers, distributors, prescribers, dispensers, administrators, research
307 practitioners, or laboratories performing analysis if consistent with the public health and
308 safety.
309 (e) A separate license is required at each principal place of business or professional
310 practice where the applicant manufactures, produces, distributes, dispenses, conducts research
311 with, or performs laboratory analysis upon controlled substances.
312 (f) The division may enact rules providing for the inspection of a licensee or
313 applicant's establishment, and may inspect the establishment according to those rules.
314 (3) (a) Upon proper application, the division shall license a qualified applicant to
315 manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
316 controlled substances included in Schedules I through V, unless it determines that issuance of
317 a license is inconsistent with the public interest. The division shall not issue a license to any
318 person to prescribe, dispense, or administer a Schedule I controlled substance. In determining
319 public interest, the division shall consider whether or not the applicant has:
320 (i) maintained effective controls against diversion of controlled substances and any
321 Schedule I or II substance compounded from any controlled substance into other than
322 legitimate medical, scientific, or industrial channels;
323 (ii) complied with applicable state and local law;
324 (iii) been convicted under federal or state laws relating to the manufacture,
325 distribution, or dispensing of substances;
326 (iv) past experience in the manufacture of controlled dangerous substances;
327 (v) established effective controls against diversion; and
328 (vi) complied with any other factors that the division establishes that promote the
329 public health and safety.
330 (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
331 produce, distribute, conduct research with, or perform laboratory analysis upon controlled
332 substances in Schedule I other than those specified in the license.
333 (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
334 substances in Schedules II through V if they are authorized to administer, dispense, or conduct
335 research under the laws of this state.
336 (ii) The division need not require a separate license for practitioners engaging in
337 research with nonnarcotic controlled substances in Schedules II through V where the licensee
338 is already licensed under this act in another capacity.
339 (iii) With respect to research involving narcotic substances in Schedules II through V,
340 or where the division by rule requires a separate license for research of nonnarcotic substances
341 in Schedules II through V, a practitioner shall apply to the division prior to conducting
342 research.
343 (iv) Licensing for purposes of bona fide research with controlled substances by a
344 practitioner considered qualified may be denied only on a ground specified in Subsection (4),
345 or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
346 adequately the practitioner's supply of substances against diversion from medical or scientific
347 use.
348 (v) Practitioners registered under federal law to conduct research in Schedule I
349 substances may conduct research in Schedule I substances within this state upon furnishing
350 the division evidence of federal registration.
351 (d) Compliance by manufacturers, producers, and distributors with the provisions of
352 federal law respecting registration, excluding fees, entitles them to be licensed under this
353 chapter.
354 (e) The division shall initially license those persons who own or operate an
355 establishment engaged in the manufacture, production, distribution, dispensation, or
356 administration of controlled substances prior to April 3, 1980, and who are licensed by the
357 state.
358 (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed
359 on probation, or revoked by the division upon finding that the applicant or licensee has:
360 (i) materially falsified any application filed or required pursuant to this chapter;
361 (ii) been convicted of an offense under this chapter or any law of the United States, or
362 any state, relating to any substance defined as a controlled substance;
363 (iii) been convicted of a felony under any other law of the United States or any state
364 within five years of the date of the issuance of the license;
365 (iv) had a federal license denied, suspended, or revoked by competent federal authority
366 and is no longer authorized to engage in the manufacturing, distribution, or dispensing of
367 controlled substances;
368 (v) had the licensee's license suspended or revoked by competent authority of another
369 state for violation of laws or regulations comparable to those of this state relating to the
370 manufacture, distribution, or dispensing of controlled substances;
371 (vi) violated any division rule that reflects adversely on the licensee's reliability and
372 integrity with respect to controlled substances;
373 (vii) refused inspection of records required to be maintained under this chapter by a
374 person authorized to inspect them; or
375 (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
376 purpose of manipulating human hormonal structure so as to:
377 (A) increase muscle mass, strength, or weight without medical necessity and without a
378 written prescription by any practitioner in the course of the practitioner's professional practice;
379 or
380 (B) improve performance in any form of human exercise, sport, or game.
381 (b) The division may limit revocation or suspension of a license to a particular
382 controlled substance with respect to which grounds for revocation or suspension exist.
383 (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant
384 to this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division
385 of Occupational and Professional Licensing Act, and conducted in conjunction with the
386 appropriate representative committee designated by the director of the department.
387 (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
388 Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
389 except where the division is designated by law to perform those functions, or, when not
390 designated by law, is designated by the executive director of the Department of Commerce to
391 conduct the proceedings.
392 (d) (i) The division may suspend any license simultaneously with the institution of
393 proceedings under this section if it finds there is an imminent danger to the public health or
394 safety.
395 (ii) Suspension shall continue in effect until the conclusion of proceedings, including
396 judicial review, unless withdrawn by the division or dissolved by a court of competent
397 jurisdiction.
398 (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
399 substances owned or possessed by the licensee may be placed under seal in the discretion of
400 the division.
401 (ii) Disposition may not be made of substances under seal until the time for taking an
402 appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
403 orders the sale of perishable substances and the proceeds deposited with the court.
404 (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
405 (f) The division shall notify promptly the Drug Enforcement Administration of all
406 orders suspending or revoking a license and all forfeitures of controlled substances.
407 (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and
408 inventories in conformance with the record keeping and inventory requirements of federal and
409 state law and any additional rules issued by the division.
410 (b) (i) Every physician, dentist, naturopathic physician, veterinarian, practitioner, or
411 other person who is authorized to administer or professionally use a controlled substance shall
412 keep a record of the drugs received by him and a record of all drugs administered, dispensed,
413 or professionally used by him otherwise than by a prescription.
414 (ii) A person using small quantities or solutions or other preparations of those drugs
415 for local application has complied with this Subsection (5)(b) if the person keeps a record of
416 the quantity, character, and potency of those solutions or preparations purchased or prepared
417 by him, and of the dates when purchased or prepared.
418 (6) Controlled substances in Schedules I through V may be distributed only by a
419 licensee and pursuant to an order form prepared in compliance with division rules or a lawful
420 order under the rules and regulations of the United States.
421 (7) (a) A person may not write or authorize a prescription for a controlled substance
422 unless the person is:
423 (i) a practitioner authorized to prescribe drugs and medicine under the laws of this
424 state or under the laws of another state having similar standards; and
425 (ii) licensed under this chapter or under the laws of another state having similar
426 standards.
427 (b) A person other than a pharmacist licensed under the laws of this state, or the
428 pharmacist's licensed intern, as required by Sections 58-17b-303 and 58-17b-304 , may not
429 dispense a controlled substance.
430 (c) (i) A controlled substance may not be dispensed without the written prescription of
431 a practitioner, if the written prescription is required by the federal Controlled Substances Act.
432 (ii) That written prescription shall be made in accordance with Subsection (7)(a) and
433 in conformity with Subsection (7)(d).
434 (iii) In emergency situations, as defined by division rule, controlled substances may be
435 dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
436 designated by the division and filed by the pharmacy.
437 (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
438 Subsection (7)(d).
439 (d) Except for emergency situations designated by the division, a person may not
440 issue, fill, compound, or dispense a prescription for a controlled substance unless the
441 prescription is signed by the prescriber in ink or indelible pencil or is signed with an electronic
442 signature of the prescriber as authorized by division rule, and contains the following
443 information:
444 (i) the name, address, and registry number of the prescriber;
445 (ii) the name, address, and age of the person to whom or for whom the prescription is
446 issued;
447 (iii) the date of issuance of the prescription; and
448 (iv) the name, quantity, and specific directions for use by the ultimate user of the
449 controlled substance.
450 (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
451 controlled substance.
452 (f) Except when administered directly to an ultimate user by a licensed practitioner,
453 controlled substances are subject to the following restrictions:
454 (i) (A) A prescription for a Schedule II substance may not be refilled.
455 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
456 one-month's supply, as directed on the daily dosage rate of the prescriptions.
457 (ii) A Schedule III or IV controlled substance may be filled only within six months of
458 issuance, and may not be refilled more than six months after the date of its original issuance or
459 be refilled more than five times after the date of the prescription unless renewed by the
460 practitioner.
461 (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
462 prescription directs, but they may not be refilled one year after the date the prescription was
463 issued unless renewed by the practitioner.
464 (iv) Any prescription for a Schedule II substance may not be dispensed if it is not
465 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
466 after the date the prescription was issued, or 30 days after the dispensing date, if that date is
467 specified separately from the date of issue.
468 (v) A practitioner may issue more than one prescription at the same time for the same
469 Schedule II controlled substance, but only under the following conditions:
470 (A) no more than three prescriptions for the same Schedule II controlled substance
471 may be issued at the same time;
472 (B) no one prescription may exceed a 30-day supply;
473 (C) a second or third prescription shall include the date of issuance and the date for
474 dispensing; and
475 (D) unless the practitioner determines there is a valid medical reason to the contrary,
476 the date for dispensing a second or third prescription may not be fewer than 30 days from the
477 dispensing date of the previous prescription.
478 (vi) Each prescription for a controlled substance may contain only one controlled
479 substance per prescription form and may not contain any other legend drug or prescription
480 item.
481 (g) An order for a controlled substance in Schedules II through V for use by an
482 inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
483 Subsection (7) if the order is:
484 (i) issued or made by a prescribing practitioner who holds an unrestricted registration
485 with the federal Drug Enforcement Administration, and an active Utah controlled substance
486 license in good standing issued by the division under this section, or a medical resident who is
487 exempted from licensure under Subsection 58-1-307 (1)(c);
488 (ii) authorized by the prescribing practitioner treating the patient and the prescribing
489 practitioner designates the quantity ordered;
490 (iii) entered upon the record of the patient, the record is signed by the prescriber
491 affirming the prescriber's authorization of the order within 48 hours after filling or
492 administering the order, and the patient's record reflects the quantity actually administered;
493 and
494 (iv) filled and dispensed by a pharmacist practicing the pharmacist's profession within
495 the physical structure of the hospital, or the order is taken from a supply lawfully maintained
496 by the hospital and the amount taken from the supply is administered directly to the patient
497 authorized to receive it.
498 (h) A practitioner licensed under this chapter may not prescribe, administer, or
499 dispense a controlled substance to a child, without first obtaining the consent required in
500 Section 78B-3-406 of a parent, guardian, or person standing in loco parentis of the child
501 except in cases of an emergency. For purposes of this Subsection (7)(h), "child" has the same
502 meaning as defined in Section 78A-6-105 , and "emergency" means any physical condition
503 requiring the administration of a controlled substance for immediate relief of pain or suffering.
504 (i) A practitioner licensed under this chapter may not prescribe or administer dosages
505 of a controlled substance in excess of medically recognized quantities necessary to treat the
506 ailment, malady, or condition of the ultimate user.
507 (j) A practitioner licensed under this chapter may not prescribe, administer, or
508 dispense any controlled substance to another person knowing that the other person is using a
509 false name, address, or other personal information for the purpose of securing the controlled
510 substance.
511 (k) A person who is licensed under this chapter to manufacture, distribute, or dispense
512 a controlled substance may not manufacture, distribute, or dispense a controlled substance to
513 another licensee or any other authorized person not authorized by this license.
514 (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a
515 symbol required by this chapter or by a rule issued under this chapter.
516 (m) A person licensed under this chapter may not refuse or fail to make, keep, or
517 furnish any record notification, order form, statement, invoice, or information required under
518 this chapter.
519 (n) A person licensed under this chapter may not refuse entry into any premises for
520 inspection as authorized by this chapter.
521 (o) A person licensed under this chapter may not furnish false or fraudulent material
522 information in any application, report, or other document required to be kept by this chapter or
523 willfully make any false statement in any prescription, order, report, or record required by this
524 chapter.
525 (8) (a) (i) Any person licensed under this chapter who is found by the division to have
526 violated any of the provisions of Subsections (7)(k) through (7)(o) is subject to a penalty not to
527 exceed $5,000. The division shall determine the procedure for adjudication of any violations
528 in accordance with Sections 58-1-106 and 58-1-108 .
529 (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in the
530 General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
531 (b) Any person who knowingly and intentionally violates Subsections (7)(h) through
532 (7)(j) is:
533 (i) upon first conviction, guilty of a class B misdemeanor;
534 (ii) upon second conviction, guilty of a class A misdemeanor; and
535 (iii) on third or subsequent conviction, guilty of a third degree felony.
536 (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
537 (7)(o) shall upon conviction be guilty of a third degree felony.
538 (9) Any information communicated to any licensed practitioner in an attempt to
539 unlawfully procure, or to procure the administration of, a controlled substance is not
540 considered to be a privileged communication.
541 Section 3. Section 58-71-102 is amended to read:
542 58-71-102. Definitions.
543 In addition to the definitions in Section 58-1-102 , as used in this chapter:
544 (1) "Administrative penalty" means a monetary fine imposed by the division for acts
545 or omissions determined to constitute unprofessional or unlawful conduct, as a result of an
546 adjudicative proceeding conducted in accordance with Title 63G, Chapter 4, Administrative
547 Procedures Act.
548 (2) "Acupuncture" has the same definition as in Section 58-72-102 .
549 (3) "Board" means the Naturopathic Physicians Licensing Board created in Section
550 58-71-201 .
551 (4) "Diagnose" means:
552 (a) to examine in any manner another person, parts of a person's body, substances,
553 fluids, or materials excreted, taken, or removed from a person's body, or produced by a
554 person's body, to determine the source, nature, kind, or extent of a disease or other physical or
555 mental condition;
556 (b) to attempt to conduct an examination or determination described under Subsection
557 (4)(a);
558 (c) to hold oneself out as making or to represent that one is making an examination or
559 determination as described in Subsection (4)(a); or
560 (d) to make an examination or determination as described in Subsection (4)(a) upon or
561 from information supplied directly or indirectly by another person, whether or not in the
562 presence of the person making or attempting the diagnosis or examination.
563 (5) "Local anesthesia" means an agent, whether a natural medicine or prescription
564 drug, which:
565 (a) is applied topically or by injection in superficial tissues associated with the
566 performance of minor office procedures;
567 (b) has the ability to produce loss of sensation at the site of minor office procedures;
568 and
569 (c) does not cause loss of consciousness or produce general sedation.
570 (6) "Medical naturopathic assistant" means an unlicensed individual working under
571 the direct and immediate supervision of a licensed naturopathic physician and engaged in
572 specific tasks assigned by the licensed naturopathic physician in accordance with the
573 standards and ethics of the profession.
574 (7) (a) "Minor office procedures" means:
575 (i) the use of operative, electrical, or other methods for repair and care of superficial
576 lacerations, abrasions, and benign lesions;
577 (ii) removal of foreign bodies located in the superficial tissues, excluding the eye or
578 ear; and
579 (iii) the use of antiseptics and local anesthetics in connection with minor office
580 surgical procedures[
581 (b) "Minor office procedures" does not include:
582 (i) general or spinal anesthesia;
583 (ii) office procedures more complicated or extensive than those set forth in Subsection
584 (7)(a);
585 (iii) procedures involving the eye; or
586 (iv) any office procedure involving tendons, nerves, veins, or arteries.
587 (8) "Natural medicine" means:
588 (a) food, food extracts, dietary supplements as defined by the federal Food, Drug, and
589 Cosmetics Act, all homeopathic remedies, and plant substances that are not designated as
590 prescription drugs or controlled substances;
591 (b) over-the-counter medications;
592 (c) other nonprescription substances, the prescription or administration of which is not
593 otherwise prohibited or restricted under federal or state law; [
594 (d) prescription drugs:
595 (i) that, except as provided in Subsection (8)(e), are not controlled substances as
596 defined in Section 58-37-2 ;
597 (ii) the prescription of which is consistent with the competent practice of naturopathic
598 medicine; and
599 (iii) the prescription of which is approved by the division in collaboration with the
600 naturopathic formulary advisory peer committee[
601 (e) testosterone, if the testosterone is:
602 (i) bio-identical;
603 (ii) designed to be:
604 (A) administered topically, for transdermal absorption; or
605 (B) absorbed across the mucosal membranes of the mouth; and
606 (iii) prescribed or administered, in accordance with the requirements of federal and
607 state law, solely for the purpose of treating a patient with a low testosterone level in order to
608 restore the patient to a normal testosterone level.
609 (9) (a) "Naturopathic childbirth" means uncomplicated natural childbirth assisted by a
610 naturopathic physician, and includes the use of:
611 (i) natural medicines; and
612 (ii) uncomplicated episiotomy.
613 (b) "Naturopathic childbirth" does not include the use of:
614 (i) forceps delivery;
615 (ii) general or spinal anesthesia;
616 (iii) caesarean section delivery; or
617 (iv) induced labor or abortion.
618 (10) "Naturopathic mobilization therapy":
619 (a) means manually administering mechanical treatment of body structures or tissues
620 for the purpose of restoring normal physiological function to the body by normalizing and
621 balancing the musculoskeletal system of the body;
622 (b) does not mean manipulation or adjustment of the joints of the human body beyond
623 the elastic barrier; and
624 (c) does not include manipulation as defined in Title 58, Chapter 73, Chiropractic
625 Physician Practice Act.
626 (11) "Naturopathic physical medicine" means the use of the physical agents of air,
627 water, heat, cold, sound, light, and electromagnetic nonionizing radiation, and the physical
628 modalities of electrotherapy, biofeedback, acupuncture, diathermy, ultraviolet light,
629 ultrasound, hydrotherapy, naturopathic mobilization therapy, and exercise. Naturopathic
630 medicine does not include the practice of physical therapy or physical rehabilitation.
631 (12) "Practice of naturopathic medicine" means:
632 (a) a system of primary health care for the prevention, diagnosis, and treatment of
633 human health conditions, injuries, and diseases that uses education, natural medicines, and
634 natural therapies, to support and stimulate the patient's intrinsic self-healing processes:
635 (i) using naturopathic childbirth, but only if:
636 (A) the licensee meets standards of the American College of Naturopathic
637 Obstetricians (ACNO) or its successor as determined by the division in collaboration with the
638 board; and
639 (B) the licensee follows a written plan for naturopathic physicians practicing
640 naturopathic childbirth approved by the division in collaboration with the board, which
641 includes entering into an agreement with a consulting physician and surgeon or osteopathic
642 physician, in cases where the scope of practice of naturopathic childbirth may be exceeded and
643 specialty care and delivery is indicated, detailing the guidelines by which the naturopathic
644 physician will:
645 (I) refer patients to the consulting physician; and
646 (II) consult with the consulting physician;
647 (ii) using naturopathic mobilization therapy;
648 (iii) using naturopathic physical medicine;
649 (iv) using minor office procedures;
650 (v) prescribing or administering natural medicine;
651 (vi) prescribing medical equipment and devices, diagnosing by the use of medical
652 equipment and devices, and administering therapy or treatment by the use of medical devices
653 necessary and consistent with the competent practice of naturopathic medicine;
654 (vii) prescribing barrier devices for contraception;
655 (viii) using dietary therapy;
656 (ix) taking and using diagnostic x-rays, electrocardiograms, ultrasound, and
657 physiological function tests;
658 (x) taking of body fluids for clinical laboratory tests and using the results of the tests
659 in diagnosis;
660 (xi) taking of a history from and conducting of a physical examination upon a human
661 patient; and
662 (xii) prescribing and administering natural medicines and medical devices, except a
663 naturopathic physician may only administer:
664 (A) a prescription drug, as defined in Section 58-17b-102 , in accordance with
665 Subsection (8)(d); and
666 (B) local anesthesia that is not a controlled substance, and only in the performance of
667 minor office procedures;
668 (b) to maintain an office or place of business for the purpose of doing any of the acts
669 described in Subsection (12)(a), whether or not for compensation; or
670 (c) to use, in the conduct of any occupation or profession pertaining to the diagnosis
671 or treatment of human diseases or conditions, in any printed material, stationery, letterhead,
672 envelopes, signs, or advertisements, the designation "naturopathic physician," "naturopathic
673 doctor," "naturopath," "doctor of naturopathic medicine," "doctor of naturopathy,"
674 "naturopathic medical doctor," "naturopathic medicine," "naturopathic health care,"
675 "naturopathy," "N.D.," "N.M.D.," or any combination of these designations in any manner that
676 might cause a reasonable person to believe the individual using the designation is a licensed
677 naturopathic physician.
678 (13) "Prescription drug or device" means:
679 (a) a drug or device which, under federal law, is required to be labeled with either of
680 the following statements or their equivalent:
681 (i) "CAUTION: Federal law prohibits dispensing without prescription"; or
682 (ii) "CAUTION: Federal law restricts this drug to use by or on the order of a licensed
683 veterinarian"; or
684 (b) a drug or device that is required by any applicable federal or state law or rule to be
685 dispensed on prescription only or is restricted to use by practitioners only.
686 (14) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-71-501 .
687 (15) "Unprofessional conduct" is as defined in Sections 58-1-501 and 58-71-502 , and
688 as may be further defined by division rule.
689 Section 4. Section 58-71-804 is amended to read:
690 58-71-804. Insurance coverage not mandated.
691 (1) This chapter does not mandate health insurance coverage for naturopathic medical
692 services.
693 (2) This chapter does not establish a class of health care providers for the purposes of
694 Section 31A-22-618 .
695 (3) This chapter does not mandate health insurance coverage for the prescription or
696 administration of testosterone, as described in Subsection 58-71-102 (8)(e), by a naturopathic
697 physician.
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