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S.B. 114
This document includes Senate Committee Amendments incorporated into the bill on Fri, Feb 13, 2004 at 11:13 AM by rday. --> This document includes Senate 2nd Reading Floor Amendments incorporated into the bill on Fri, Feb 20, 2004 at 5:10 PM by rday. --> This document includes Senate 3rd Reading Floor Amendments incorporated into the bill on Tue, Feb 24, 2004 at 10:12 AM by rday. --> This document includes House Floor Amendments incorporated into the bill on Fri, Feb 27, 2004 at 5:50 PM by chopkin. --> 1
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8 LONG TITLE
9 General Description:
10 This bill repeals the current Pharmacy Practice Act and enacts a new Pharmacy Practice
11 Act.
12 Highlighted Provisions:
13 This bill:
13a S . AMENDS THE DEFINITION OF UNLAWFUL AND UNPROFESSIONAL CONDUCT TO
13b INCLUDE PRESCRIBING A DRUG OR DEVICE WITHOUT A DIAGNOSIS OR A BONA FIDE
13c PATIENT-PRACTITIONER RELATIONSHIP; s
14 . enacts a new Pharmacy Practice Act and includes:
15 . definitions;
16 . administrative inspections;
17 . board membership, qualifications, and terms;
18 . license classifications for pharmacy facilities;
19 . qualifications for licensure as a pharmacist;
20 . qualifications for licensure as a pharmacy intern;
21 . qualifications for licensure as a pharmacy technician;
22 . qualifications for licensure as a pharmacy;
23 . criminal background checks;
24 . terms of license;
25 . exemptions from licensure;
26 . continuing education;
27 . grounds for denial of licensure;
28
29 . regulation of the practice of pharmacy operating standards; and
30 . provisions related to incapacitated pharmacists;
31 . amends the sunset date of the Pharmacy Practice Act to July 1, 2014; and
32 . makes technical amendments.
33 Monies Appropriated in this Bill:
34 None
35 Other Special Clauses:
36 This bill takes effect on July 1, 2004.
37 Utah Code Sections Affected:
38 AMENDS:
39 16-11-2, as last amended by Chapter 185, Laws of Utah 2002
40 26-18-2.3, as last amended by Chapter 324, Laws of Utah 2003
41 26-18-101, as last amended by Chapters 79, 247 and 248, Laws of Utah 1996
42 26-47-101, as enacted by Chapter 310, Laws of Utah 2003
43 48-2c-1502, as last amended by Chapter 185, Laws of Utah 2002
44 58-1-307, as last amended by Chapter 3, Laws of Utah 2003
44a S 58-1-501, AS LAST AMENDED BY CHAPTER 148, LAWS OF UTAH 2001 s
45 58-16a-102, as last amended by Chapter 270, Laws of Utah 2003
46 58-24a-105, as last amended by Chapter 247, Laws of Utah 1996
47 58-37-6, as last amended by Chapter 33, Laws of Utah 2003
48 58-37-7.5, as last amended by Chapter 33, Laws of Utah 2003
49 58-37c-19.5, as enacted by Chapter 272, Laws of Utah 2000
50 58-71-102, as last amended by Chapter 131, Laws of Utah 2003
51 58-71-801, as enacted by Chapter 282, Laws of Utah 1996
52 58-73-601, as last amended by Chapter 284, Laws of Utah 1998
53 63-55-258, as last amended by Chapters 49 and 254, Laws of Utah 2003
54 76-5-113, as enacted by Chapter 164, Laws of Utah 2001
55 76-8-311.3, as last amended by Chapter 8, Laws of Utah 2002, Fifth Special Session
56 78-11-22.2, as enacted by Chapter 152, Laws of Utah 2000
57 78-14-3, as last amended by Chapter 131, Laws of Utah 2002
58 ENACTS:
59
60 58-17b-102, Utah Code Annotated 1953
61 58-17b-103, Utah Code Annotated 1953
62 58-17b-201, Utah Code Annotated 1953
63 58-17b-301, Utah Code Annotated 1953
64 58-17b-302, Utah Code Annotated 1953
65 58-17b-303, Utah Code Annotated 1953
66 58-17b-304, Utah Code Annotated 1953
67 58-17b-305, Utah Code Annotated 1953
68 58-17b-306, Utah Code Annotated 1953
69 58-17b-307, Utah Code Annotated 1953
70 58-17b-308, Utah Code Annotated 1953
71 58-17b-309, Utah Code Annotated 1953
72 58-17b-310, Utah Code Annotated 1953
73 58-17b-401, Utah Code Annotated 1953
74 58-17b-501, Utah Code Annotated 1953
75 58-17b-502, Utah Code Annotated 1953
76 58-17b-503, Utah Code Annotated 1953
77 58-17b-504, Utah Code Annotated 1953
78 58-17b-505, Utah Code Annotated 1953
79 58-17b-506, Utah Code Annotated 1953
80 58-17b-601, Utah Code Annotated 1953
81 58-17b-602, Utah Code Annotated 1953
82 58-17b-603, Utah Code Annotated 1953
83 58-17b-604, Utah Code Annotated 1953
84 58-17b-605, Utah Code Annotated 1953
85 58-17b-606, Utah Code Annotated 1953
86 58-17b-607, Utah Code Annotated 1953
87 58-17b-608, Utah Code Annotated 1953
88 58-17b-609, Utah Code Annotated 1953
89 58-17b-610, Utah Code Annotated 1953
90
91 58-17b-612, Utah Code Annotated 1953
92 58-17b-613, Utah Code Annotated 1953
93 58-17b-614, Utah Code Annotated 1953
94 58-17b-615, Utah Code Annotated 1953
95 58-17b-616, Utah Code Annotated 1953
96 58-17b-617, Utah Code Annotated 1953
97 58-17b-618, Utah Code Annotated 1953
98 58-17b-619, Utah Code Annotated 1953
99 58-17b-620, Utah Code Annotated 1953
100 58-17b-621, Utah Code Annotated 1953
101 58-17b-701, Utah Code Annotated 1953
102 REPEALS:
103 58-17a-101, as enacted by Chapter 247, Laws of Utah 1996
104 58-17a-102, as last amended by Chapter 184, Laws of Utah 2002
105 58-17a-103, as enacted by Chapter 28, Laws of Utah 1998
106 58-17a-201, as enacted by Chapter 247, Laws of Utah 1996
107 58-17a-301, as enacted by Chapter 247, Laws of Utah 1996
108 58-17a-302, as last amended by Chapter 28, Laws of Utah 1998
109 58-17a-304, as enacted by Chapter 247, Laws of Utah 1996
110 58-17a-305, as last amended by Chapter 160, Laws of Utah 2000
111 58-17a-401, as enacted by Chapter 247, Laws of Utah 1996
112 58-17a-402, as enacted by Chapter 247, Laws of Utah 1996
113 58-17a-501, as last amended by Chapter 28, Laws of Utah 1998
114 58-17a-502, as last amended by Chapter 184, Laws of Utah 2002
115 58-17a-502.5, as enacted by Chapter 18, Laws of Utah 2002, Fifth Special Session
116 58-17a-503, as enacted by Chapter 247, Laws of Utah 1996
117 58-17a-601, as enacted by Chapter 247, Laws of Utah 1996
118 58-17a-602, as enacted by Chapter 247, Laws of Utah 1996
119 58-17a-603, as enacted by Chapter 247, Laws of Utah 1996
120 58-17a-604, as enacted by Chapter 247, Laws of Utah 1996
121
122 58-17a-606, as enacted by Chapter 247, Laws of Utah 1996
123 58-17a-607, as enacted by Chapter 247, Laws of Utah 1996
124 58-17a-608, as enacted by Chapter 247, Laws of Utah 1996
125 58-17a-609, as enacted by Chapter 247, Laws of Utah 1996
126 58-17a-610, as enacted by Chapter 247, Laws of Utah 1996
127 58-17a-611, as last amended by Chapter 344, Laws of Utah 2001
128 58-17a-612, as enacted by Chapter 247, Laws of Utah 1996
129 58-17a-613, as enacted by Chapter 247, Laws of Utah 1996
130 58-17a-614, as enacted by Chapter 247, Laws of Utah 1996
131 58-17a-615, as enacted by Chapter 247, Laws of Utah 1996
132 58-17a-616, as enacted by Chapter 247, Laws of Utah 1996
133 58-17a-617, as enacted by Chapter 247, Laws of Utah 1996
134 58-17a-618, as enacted by Chapter 247, Laws of Utah 1996
135 58-17a-619, as enacted by Chapter 247, Laws of Utah 1996
136 58-17a-620, as last amended by Chapter 3, Laws of Utah 2003
137 58-17a-701, as enacted by Chapter 247, Laws of Utah 1996
138 58-17a-801, as last amended by Chapter 8, Laws of Utah 2002, Fifth Special Session
139
140 Be it enacted by the Legislature of the state of Utah:
141 Section 1. Section 16-11-2 is amended to read:
142 16-11-2. Definitions.
143 As used in this chapter:
144 (1) "Filed" means the division has received and approved, as to form, a document
145 submitted under the provisions of this chapter, and has marked on the face of the document a
146 stamp or seal indicating the time of day and date of approval, the name of the division, the
147 division director's signature and division seal, or facsimiles of the signature or seal.
148 (2) "Professional corporation" means a corporation organized under this chapter.
149 (3) "Professional service" means the personal service rendered by:
150 (a) a physician, surgeon, or doctor of medicine holding a license under Title 58,
151 Chapter 67, Utah Medical Practice Act, and any subsequent laws regulating the practice of
152
153 (b) a doctor of dentistry holding a license under Title 58, Chapter 69, Dentist and
154 Dental Hygienist Practice Act, and any subsequent laws regulating the practice of dentistry;
155 (c) an osteopathic physician or surgeon holding a license under Title 58, Chapter 68,
156 Utah Osteopathic Medical Practice Act, and any subsequent laws regulating the practice of
157 osteopathy;
158 (d) a chiropractor holding a license under Title 58, Chapter 73, Chiropractic Physician
159 Practice Act, and any subsequent laws regulating the practice of chiropractic;
160 (e) a podiatric physician holding a license under Title 58, Chapter 5a, Podiatric
161 Physician Licensing Act, and any subsequent laws regulating the practice of podiatry;
162 (f) an optometrist holding a license under Title 58, Chapter 16a, Utah Optometry
163 Practice Act, and any subsequent laws regulating the practice of optometry;
164 (g) a veterinarian holding a license under Title 58, Chapter 28, Veterinary Practice Act,
165 and any subsequent laws regulating the practice of veterinary medicine;
166 (h) an architect holding a license under Title 58, Chapter 3a, Architects Licensing Act,
167 and any subsequent laws regulating the practice of architecture;
168 (i) a public accountant holding a license under Title 58, Chapter 26a, Certified Public
169 Accountant Licensing Act, and any subsequent laws regulating the practice of public
170 accounting;
171 (j) a naturopath holding a license under Title 58, Chapter 71, Naturopathic Physician
172 Practice Act, and any subsequent laws regulating the practice of naturopathy;
173 (k) a pharmacist holding a license under Title 58, Chapter [
174 Practice Act, and any subsequent laws regulating the practice of pharmacy;
175 (l) an attorney granted the authority to practice law by:
176 (i) the Utah Supreme Court; or
177 (ii) the Supreme Court, other court, agency, instrumentality, or regulating board that
178 licenses or regulates the authority to practice law in any state or territory of the United States
179 other than Utah;
180 (m) a professional engineer registered under Title 58, Chapter 22, Professional
181 Engineers and Professional Land Surveyor Licensing Act;
182 (n) a real estate broker or real estate agent holding a license under Title 61, Chapter 2,
183
184 purchasing, renting, or leasing of real estate;
185 (o) a psychologist holding a license under Title 58, Chapter 61, Psychologist Licensing
186 Act, and any subsequent laws regulating the practice of psychology;
187 (p) a clinical or certified social worker holding a license under Title 58, Chapter 60,
188 Part 2, Social Worker Licensing Act, and any subsequent laws regulating the practice of social
189 work;
190 (q) a physical therapist holding a license under Title 58, Chapter 24a, Physical
191 Therapist Practice Act, and any subsequent laws regulating the practice of physical therapy; or
192 (r) a nurse licensed under Title 58, Chapter 31b, Nurse Practice Act, or Title 58,
193 Chapter 44a, Nurse Midwife Practice Act.
194 (4) "Regulating board" means the board that is charged with the licensing and
195 regulation of the practice of the profession which the professional corporation is organized to
196 render. The definitions of Title 16, Chapter 10a, Utah Revised Business Corporation Act,
197 apply to this chapter unless the context clearly indicates that a different meaning is intended.
198 Section 2. Section 26-18-2.3 is amended to read:
199 26-18-2.3. Division responsibilities -- Emphasis -- Periodic assessment.
200 (1) In accordance with the requirements of Title XIX of the Social Security Act and
201 applicable federal regulations, the division is responsible for the effective and impartial
202 administration of this chapter in an efficient, economical manner. The division shall:
203 (a) establish, on a statewide basis, a program to safeguard against unnecessary or
204 inappropriate use of Medicaid services, excessive payments, and unnecessary or inappropriate
205 hospital admissions or lengths of stay;
206 (b) deny any provider claim for services that fail to meet criteria established by the
207 division concerning medical necessity or appropriateness; and
208 (c) place its emphasis on high quality care to recipients in the most economical and
209 cost-effective manner possible, with regard to both publicly and privately provided services.
210 (2) The division shall implement and utilize cost-containment methods, where
211 possible, which may include, but are not limited to:
212 (a) prepayment and postpayment review systems to determine if utilization is
213 reasonable and necessary;
214
215 (c) mandatory outpatient, rather than inpatient, surgery in appropriate cases;
216 (d) second surgical opinions;
217 (e) procedures for encouraging the use of outpatient services;
218 (f) consistent with Sections 28-18-2.4 and [
219 drug program;
220 (g) coordination of benefits; and
221 (h) review and exclusion of providers who are not cost effective or who have abused
222 the Medicaid program, in accordance with the procedures and provisions of federal law and
223 regulation.
224 (3) The director of the division shall periodically assess the cost effectiveness and
225 health implications of the existing Medicaid program, and consider alternative approaches to
226 the provision of covered health and medical services through the Medicaid program, in order to
227 reduce unnecessary or unreasonable utilization.
228 Section 3. Section 26-18-101 is amended to read:
229 26-18-101. Definitions.
230 As used in this part:
231 (1) "Appropriate and medically necessary" means, regarding drug prescribing,
232 dispensing, and patient usage, that it is in conformity with the criteria and standards developed
233 in accordance with this part.
234 (2) "Board" means the Drug Utilization Review Board created in Section 26-18-102 .
235 (3) "Compendia" means resources widely accepted by the medical profession in the
236 efficacious use of drugs, including "American Hospital Formulary Services Drug Information,"
237 "U.S. Pharmacopeia - Drug Information," "A.M.A. Drug Evaluations," peer-reviewed medical
238 literature, and information provided by manufacturers of drug products.
239 (4) "Counseling" means the activities conducted by a pharmacist to inform Medicaid
240 recipients about the proper use of drugs, as required by the board under this part.
241 (5) "Criteria" means those predetermined and explicitly accepted elements used to
242 measure drug use on an ongoing basis in order to determine if the use is appropriate, medically
243 necessary, and not likely to result in adverse medical outcomes.
244 (6) "Drug-disease contraindications" means that the therapeutic effect of a drug is
245
246 (7) "Drug-interactions" means that two or more drugs taken by a recipient lead to
247 clinically significant toxicity that is characteristic of one or any of the drugs present, or that
248 leads to interference with the effectiveness of one or any of the drugs.
249 (8) "Drug Utilization Review" or "DUR" means the program designed to measure and
250 assess, on a retrospective and prospective basis, the proper use of outpatient drugs in the
251 Medicaid program.
252 (9) "Intervention" means a form of communication utilized by the board with a
253 prescriber or pharmacist to inform about or influence prescribing or dispensing practices.
254 (10) "Overutilization" or "underutilization" means the use of a drug in such quantities
255 that the desired therapeutic goal is not achieved.
256 (11) "Pharmacist" means a person licensed in this state to engage in the practice of
257 pharmacy under Title 58, Chapter [
258 (12) "Physician" means a person licensed in this state to practice medicine and surgery
259 under Section 58-67-301 [
260 58-68-301 [
261 (13) "Prospective DUR" means that part of the drug utilization review program that
262 occurs before a drug is dispensed, and that is designed to screen for potential drug therapy
263 problems based on explicit and predetermined criteria and standards.
264 (14) "Retrospective DUR" means that part of the drug utilization review program that
265 assesses or measures drug use based on an historical review of drug use data against
266 predetermined and explicit criteria and standards, on an ongoing basis with professional input.
267 (15) "Standards" means the acceptable range of deviation from the criteria that reflects
268 local medical practice and that is tested on the Medicaid recipient database.
269 (16) "SURS" means the Surveillance Utilization Review System of the Medicaid
270 program.
271 (17) "Therapeutic appropriateness" means drug prescribing and dispensing based on
272 rational drug therapy that is consistent with criteria and standards.
273 (18) "Therapeutic duplication" means prescribing and dispensing the same drug or two
274 or more drugs from the same therapeutic class where periods of drug administration overlap
275 and where that practice is not medically indicated.
276
277 26-47-101. Prescription Drug Assistance Program.
278 (1) No later than October 1, 2003, the department shall implement a Prescription Drug
279 Assistance Program. The program shall assist persons seeking information about how to obtain
280 prescription drugs at a reduced price or no cost. The program shall:
281 (a) collect eligibility and enrollment information about programs that make
282 prescription drugs available to consumers at a reduced price or no cost;
283 (b) provide information collected under Subsection (1)(a) to consumers upon request
284 via a toll-free phone line, the Internet, and mail;
285 (c) inform pharmacists and other health care providers of the Prescription Drug
286 Assistance Program; and
287 (d) assist consumers in completing applications to participate in programs identified
288 under Subsection (1)(a).
289 (2) Any pharmaceutical manufacturer, distributor, or wholesaler operating in the state
290 shall:
291 (a) notify the department of any program operated by it to provide prescription drugs to
292 consumers at a reduced price or no cost; and
293 (b) provide the department with information about eligibility, enrollment, and benefits.
294 (3) Pharmacies, as defined in Title 58, Chapter [
295 notify their patients of the Prescription Drug Assistance Program. This notification shall
296 include displaying the program's toll-free number, and may include distributing a brochure or
297 oral communication.
298 (4) The department may accept grants, gifts, and donations of money or property for
299 use by the Prescription Drug Assistance Program.
300 (5) The department shall report to the Health and Human Services Interim Committee
301 and the Joint Health and Human Services Appropriations Subcommittee on the performance of
302 the Prescription Drug Assistance Program prior to the 2004 and 2005 Annual General Sessions
303 of the Legislature.
304 Section 5. Section 48-2c-1502 is amended to read:
305 48-2c-1502. Definitions.
306 As used in this part:
307
308 under this part to render professional services.
309 (2) "Professional services" means the personal services rendered by:
310 (a) an architect holding a license under Title 58, Chapter 3a, Architects Licensing Act,
311 and any subsequent laws regulating the practice of architecture;
312 (b) an attorney granted the authority to practice law by the:
313 (i) Supreme Court of Utah; or
314 (ii) the Supreme Court, other court, agency, instrumentality, or regulating board that
315 licenses or regulates the authority to practice law in any state or territory of the United States
316 other than Utah;
317 (c) a chiropractor holding a license under Title 58, Chapter 73, Chiropractic Physician
318 Practice Act, and any subsequent laws regulating the practice of chiropractic;
319 (d) a doctor of dentistry holding a license under Title 58, Chapter 69, Dentists and
320 Dental Hygienists Practice Act, and any subsequent laws, regulating the practice of dentistry;
321 (e) a professional engineer registered under Title 58, Chapter 22, Professional
322 Engineers and Professional Land Surveyors Licensing Act;
323 (f) a naturopath holding a license under Title 58, Chapter 71, Naturopathic Physician
324 Practice Act, and any subsequent laws regulating the practice of naturopathy;
325 (g) a nurse licensed under Title 58, Chapter 31b, Nurse Practice Act, or Title 58,
326 Chapter 44a, Nurse Midwife Practice Act;
327 (h) an optometrist holding a license under Title 58, Chapter 16a, Utah Optometry
328 Practice Act, and any subsequent laws regulating the practice of optometry;
329 (i) an osteopathic physician or surgeon holding a license under Title 58, Chapter 68,
330 Utah Osteopathic Medical Practice Act, and any subsequent laws regulating the practice of
331 osteopathy;
332 (j) a pharmacist holding a license under Title 58, Chapter [
333 Act, and any subsequent laws regulating the practice of pharmacy;
334 (k) a physician, surgeon, or doctor of medicine holding a license under Title 58,
335 Chapter 67, Utah Medical Practice Act, and any subsequent laws regulating the practice of
336 medicine;
337 (l) a physical therapist holding a license under Title 58, Chapter 24a, Physical
338
339 (m) a podiatric physician holding a license under Title 58, Chapter 5a, Podiatric
340 Physician Licensing Act, and any subsequent laws regulating the practice of podiatry;
341 (n) a psychologist holding a license under Title 58, Chapter 61, Psychologist Licensing
342 Act, and any subsequent laws regulating the practice of psychology;
343 (o) a public accountant holding a license under Title 58, Chapter 26a, Certified Public
344 Accountant Licensing Act, and any subsequent laws regulating the practice of public
345 accounting;
346 (p) a real estate broker or real estate agent holding a license under Title 61, Chapter 2,
347 Division of Real Estate, and any subsequent laws regulating the sale, exchange, purchase,
348 rental, or leasing of real estate;
349 (q) a clinical or certified social worker holding a license under Title 58, Chapter 60,
350 Part 2, Social Worker Licensing Act, and any subsequent laws regulating the practice of social
351 work;
352 (r) a mental health therapist holding a license under Title 58, Chapter 60, Mental
353 Health Professional Practice Act, and any subsequent laws regulating the practice of mental
354 health therapy; and
355 (s) a veterinarian holding a license under Title 58, Chapter 28, Veterinary Practice Act,
356 and any subsequent laws regulating the practice of veterinary medicine.
357 (3) "Regulating board" means the board or agency organized pursuant to state law that
358 is charged with the licensing and regulation of the practice of the profession that a company is
359 organized to render.
360 Section 6. Section 58-1-307 is amended to read:
361 58-1-307. Exemptions from licensure.
362 (1) Except as otherwise provided by statute or rule, the following persons may engage
363 in the practice of their occupation or profession, subject to the stated circumstances and
364 limitations, without being licensed under this title:
365 (a) a person serving in the armed forces of the United States, the United States Public
366 Health Service, the United States Department of Veterans Affairs, or other federal agencies
367 while engaged in activities regulated under this chapter as a part of employment with that
368 federal agency if the person holds a valid license to practice a regulated occupation or
369
370 (b) a student engaged in activities constituting the practice of a regulated occupation or
371 profession while in training in a recognized school approved by the division to the extent the
372 activities are supervised by qualified faculty, staff, or designee and the activities are a defined
373 part of the training program;
374 (c) an individual engaged in an internship, residency, preceptorship, postceptorship,
375 fellowship, apprenticeship, or on-the-job training program approved by the division while
376 under the supervision of qualified persons;
377 (d) an individual residing in another state and licensed to practice a regulated
378 occupation or profession in that state, who is called in for a consultation by an individual
379 licensed in this state, and the services provided are limited to that consultation;
380 (e) an individual who is invited by a recognized school, association, society, or other
381 body approved by the division to conduct a lecture, clinic, or demonstration of the practice of a
382 regulated occupation or profession if the individual does not establish a place of business or
383 regularly engage in the practice of the regulated occupation or profession in this state;
384 (f) an individual licensed under the laws of this state, other than under this title, to
385 practice or engage in an occupation or profession, while engaged in the lawful, professional,
386 and competent practice of that occupation or profession;
387 (g) an individual licensed in a health care profession in another state who performs that
388 profession while attending to the immediate needs of a patient for a reasonable period during
389 which the patient is being transported from outside of this state, into this state, or through this
390 state;
391 (h) an individual licensed in another state or country who is in this state temporarily to
392 attend to the needs of an athletic team or group, except that the practitioner may only attend to
393 the needs of the athletic team or group, including all individuals who travel with the team or
394 group in any capacity except as a spectator;
395 (i) an individual licensed and in good standing in another state, who is in this state:
396 (i) temporarily, under the invitation and control of a sponsoring entity;
397 (ii) for a reason associated with a special purpose event, based upon needs that may
398 exceed the ability of this state to address through its licensees, as determined by the division;
399 and
400
401 any necessary preparatory and conclusionary periods. The requirements of Section
402 63A-10-105 do not apply to exemptions authorized by the division pursuant to this Subsection
403 (1)(i);
404 (j) an individual who:
405 (i) is certified as an athletic trainer by the National Athletic Trainers Association Board
406 of Certification or another entity approved by the division;
407 (ii) is employed or officially associated with an educational institution, a professional
408 sports organization, or a bona fide amateur sports organization; and
409 (iii) only provides athletic training services:
410 (A) to athletes of the educational institution or sports organization to which the
411 individual is employed or officially associated;
412 (B) at an official athletic training, practice, or competition site; and
413 (C) that are within the scope of the individual's certification; and
414 (k) a law enforcement officer, as defined under Section 53-13-103 , who:
415 (i) is operating a voice stress analyzer in the course of the officer's full-time
416 employment with a federal, state, or local law enforcement agency;
417 (ii) has completed the manufacturer's training course and is certified by the
418 manufacturer to operate that voice stress analyzer; and
419 (iii) is operating the voice stress analyzer in accordance with Section 58-64-601 ,
420 regarding deception detection instruments.
421 (2) A practitioner temporarily in this state who is exempted from licensure under
422 Subsection (1) shall comply with each requirement of the licensing jurisdiction from which the
423 practitioner derives authority to practice. Violation of any limitation imposed by this section
424 constitutes grounds for removal of exempt status, denial of license, or other disciplinary
425 proceedings.
426 (3) An individual who is licensed under a specific chapter of this title to practice or
427 engage in an occupation or profession may engage in the lawful, professional, and competent
428 practice of that occupation or profession without additional licensure under other chapters of
429 this title, except as otherwise provided by this title.
430 (4) Upon the declaration of a national, state, or local emergency, a public health
431
432 States or other federal official requesting public health-related activities, the division in
433 collaboration with the board may:
434 (a) suspend the requirements for permanent or temporary licensure of persons who are
435 licensed in another state. Persons exempt under this Subsection (4)(a) shall be exempt from
436 licensure for the duration of the emergency while engaged in the scope of practice for which
437 they are licensed in the other state;
438 (b) modify, under the circumstances described in [
439 Subsection (5), the scope of practice restrictions under this title for persons who are licensed
440 under this title as:
441 (i) a physician under Chapter 67, Utah Medical Practice Act, or Chapter 68, Utah
442 Osteopathic Medical Practice Act;
443 (ii) a nurse under Chapter 31b, Nurse Practice Act, or Chapter 31c, Nurse Licensure
444 Compact;
445 (iii) a certified nurse midwife under Chapter 44a, Nurse Midwife Practice Act;
446 (iv) a pharmacist, pharmacy technician, or pharmacy intern under Chapter [
447 Pharmacy Practice Act;
448 (v) a respiratory therapist under Chapter 57, Respiratory Care Practices Act; and
449 (vi) a dentist and dental hygienist under Chapter 69, Dentist and Dental Hygienist
450 Practice Act;
451 (c) suspend the requirements for licensure under this title and modify the scope of
452 practice in the circumstances described in [
453 for medical services personnel or paramedics required to be certified under Section 26-8a-302 ;
454 and
455 (d) suspend requirements in Subsections [
456 which require certain prescriptive procedures.
457 (5) Persons exempt under Subsection (4)(c) and persons operating under modified
458 scope of practice provisions under Subsection (4)(b):
459 (a) shall be exempt from licensure or subject to modified scope of practice for the
460 duration of the emergency;
461 (b) must be engaged in the distribution of medicines or medical devises in response to
462
463 (c) must be employed by or volunteering for a local or state department of health.
464 Section 7. Section 58-16a-102 is amended to read:
464a S Section 7. Section 58-1-501 is amended to read:
464b 58-1-501. Unlawful and unprofessional conduct.
464c (1) "Unlawful conduct" means conduct, by any person, that is defined as unlawful under this
464d title and includes:
464e (a) practicing or engaging in, representing oneself to be practicing or engaging in, or
464f attempting to practice or engage in any occupation or profession requiring licensure under this title if
464g the person is:
464h (i) not licensed to do so or not exempted from licensure under this title; or
464i (ii) restricted from doing so by a suspended, revoked, restricted, temporary, probationary, or
464j inactive license;
464k (b) impersonating another licensee or practicing an occupation or profession under a false or
464l assumed name, except as permitted by law;
464m (c) knowingly employing any other person to practice or engage in or attempt to practice or
464n engage in any occupation or profession licensed under this title if the employee is not licensed to do
464o so under this title;
464p (d) knowingly permitting the person's authority to practice or engage in any occupation or
464q profession licensed under this title to be used by another, except as permitted by law; [
464r (e) obtaining a passing score on a licensure examination, applying for or obtaining a license,
464s or otherwise dealing with the division or a licensing board through the use of fraud, forgery, or
464t intentional deception, misrepresentation, misstatement, or omission[
464u (f) UNLESS SUBSECTION (2)(m) OR (3) APPLIES, ISSUING, OR AIDING AND ABETTING IN THE
464v ISSUANCE OF, AN ORDER OR PRESCRIPTION FOR A DRUG OR DEVICE TO A PERSON LOCATED IN
464w THIS STATE:
464x (i) WITHOUT PRESCRIPTIVE AUTHORITY CONFERRED BY A LICENSE ISSUED UNDER THIS
464y TITLE, OR BY AN EXEMPTION TO LICENSURE UNDER THIS TITLE;
464z (ii) WITH PRESCRIPTIVE AUTHORITY CONFERRED BY AN EXCEPTION ISSUED UNDER THIS
464aa TITLE OR A MULTISTATE PRACTICE PRIVILEGE RECOGNIZED UNDER THIS TITLE, IF THE
464ab PRESCRIPTION WAS ISSUED:
464ac (A) WITHOUT FIRST OBTAINING INFORMATION, IN THE USUAL COURSE OF PROFESSIONAL
464ad PRACTICE, THAT IS SUFFICIENT TO ESTABLISH A DIAGNOSIS, TO IDENTIFY UNDERLYING
464ae CONDITIONS, AND TO IDENTIFY CONTRAINDICATIONS TO THE PROPOSED TREATMENT; OR
464af (B) BASED ON A QUESTIONNAIRE COMPLETED BY THE PATIENT ON THE INTERNET, OR
464ag TOLL-FREE TELEPHONE NUMBER, WHEN THERE EXISTS NO OTHER BONA-FIDE
464ah PATIENT-PRACTITIONER RELATIONSHIP; OR
464ai (iii) IN VIOLATION OF SUBSECTION (2)(m), WHEN THE LICENSED PERSON WHO ISSUED,
OR
464aj
AIDED AND ABETTED ANOTHER IN THE ISSUANCE OF THE PRESCRIPTION HAS VIOLATED
464ak
SUBSECTION (2)(m) ON MORE THAN 100 PRESCRIPTIONS WITHIN A THIRTY DAY PERIOD OF TIME;
464al
AND
464am
(g) SUBSECTION (2)(f) DOES NOT APPLY TO TREATMENT RENDERED IN AN EMERGENCY,
464an
ON-CALL OR CROSS COVERAGE SITUATION, PROVIDED THAT THE PERSON WHO ISSUES s
464ao
464ap TITLE, OR IS EXEMPT FROM LICENSURE UNDER THIS TITLE.
464aq (2) "Unprofessional conduct" means conduct, by a licensee or applicant, that is defined as
464ar unprofessional conduct under this title or under any rule adopted under this title and includes:
464as (a) violating, or aiding or abetting any other person to violate, any statute, rule, or order
464at regulating an occupation or profession under this title;
464au (b) violating, or aiding or abetting any other person to violate, any generally accepted
464av professional or ethical standard applicable to an occupation or profession regulated under this title;
464aw (c) engaging in conduct that results in conviction, a plea of nolo contendere, or a plea of
464ax guilty or nolo contendere which is held in abeyance pending the successful completion of probation
464ay with respect to a crime of moral turpitude or any other crime that, when considered with the functions
464az and duties of the occupation or profession for which the license was issued or is to be issued, bears a
464ba reasonable relationship to the licensee's or applicant's ability to safely or competently practice the
464bb occupation or profession;
464bc (d) engaging in conduct that results in disciplinary action, including reprimand, censure,
464bd diversion, probation, suspension, or revocation, by any other licensing or regulatory authority having
464be jurisdiction over the licensee or applicant in the same occupation or profession if the conduct would,
464bf in this state, constitute grounds for denial of licensure or disciplinary proceedings under Section
464bg 58-1-401;
464bh (e) engaging in conduct, including the use of intoxicants, drugs, narcotics, or similar
464bi chemicals, to the extent that the conduct does, or might reasonably be considered to, impair the
464bj ability of the licensee or applicant to safely engage in the occupation or profession;
464bk (f) practicing or attempting to practice an occupation or profession regulated under this title
464bl despite being physically or mentally unfit to do so;
464bm (g) practicing or attempting to practice an occupation or profession regulated under this title
464bn through gross incompetence, gross negligence, or a pattern of incompetency or negligence;
464bo (h) practicing or attempting to practice an occupation or profession requiring licensure under
464bp this title by any form of action or communication which is false, misleading, deceptive, or fraudulent;
464bq (i) practicing or attempting to practice an occupation or profession regulated under this title
464br beyond the scope of the licensee's competency, abilities, or education;
464bs (j) practicing or attempting to practice an occupation or profession regulated under this title
464bt beyond the scope of the licensee's license;
464bu (k) verbally, physically, mentally, or sexually abusing or exploiting any person through
464bv conduct connected with the licensee's practice under this title or otherwise facilitated by the
464bw licensee's license; or
464bx (l) acting as a supervisor without meeting the qualification requirements for that position that
464by are defined by statute or rule[
464bz (m) UNLESS SUBSECTION (3) APPLIES, ISSUING, OR AIDING AND ABETTING IN THE
464ca ISSUANCE OF, AN ORDER OR PRESCRIPTION FOR A DRUG OR DEVICE:
464cb (i) WITHOUT FIRST OBTAINING INFORMATION IN THE USUAL COURSE OF PROFESSIONAL
464cc PRACTICE, THAT IS SUFFICIENT TO ESTABLISH A DIAGNOSIS, TO IDENTIFY CONDITIONS, AND TO
464cd IDENTIFY CONTRAINDICATIONS TO THE PROPOSED TREATMENT; OR
464ce (ii) BASED ON A QUESTIONNAIRE COMPLETED BY THE PATIENT ON THE INTERNET, OR
464cf TOLL FREE TELEPHONE NUMBER WHEN THERE EXISTS NO OTHER s
464cg
464ch PRACTITIONER INVOLVED IN AN EXISTING PATIENT-PRACTITIONER RELATIONSHIP.
464ci (c) SUBSECTIONS (2)(m)(i) AND (ii) DO NOT APPLY TO TREATMENT RENDERED IN AN
464cj EMERGENCY, ON-CALL, OR CROSS COVERAGE SITUATION.
464ck (3) NOTWITHSTANDING SUBSECTIONS (1)(f) AND (2)(m), THE DIVISION MAY PERMIT A
464cl PERSON LICENSED TO PRESCRIBE UNDER THIS TITLE TO PRESCRIBE A LEGEND DRUG TO A
464cm PERSON LOCATED IN THIS STATE IF THE DIVISION IN COLLABORATION WITH THE APPROPRIATE
464cn PROFESSIONAL BOARD HAS PERMITTED THE SPECIFIC PRESCRIPTIVE PRACTICE OF THE LEGEND
464co DRUG BY RULE. s
465 58-16a-102. Definitions.
466 In addition to the definitions in Section 58-1-102 , as used in this chapter:
467 (1) "Board" means the Optometrist Licensing Board created in Section 58-16a-201 .
468 (2) "Contact lens" means any lens that:
469 (a) has a spherical, cylindrical, or prismatic power or curvature;
470 (b) is made pursuant to a current prescription; or
471 (c) is intended to be worn on the surface of the eye.
472 (3) (a) "Contact lens prescription" means a written or verbal order for contact lenses
473 that includes:
474 (i) the commencement date of the prescription;
475 (ii) the base curve, power, diameter, material or brand name, and expiration date;
476 (iii) for a written order, the signature of the prescribing optometrist or physician; and
477 (iv) for a verbal order, a record maintained by the recipient of:
478 (A) the name of the prescribing optometrist or physician; and
479 (B) the date when the prescription was issued or ordered.
480 (b) A prescription may include:
481 (i) a limit on the quantity of lenses that may be ordered under the prescription if
482 required for medical reasons documented in the patient's files; and
483 (ii) the expiration date of the prescription, which shall be two years from the
484 commencement date, unless documented medical reasons require otherwise.
485 (c) When a provider prescribes a private label contact lens for a patient the prescription
486 shall include:
487 (i) the name of the manufacturer;
488 (ii) the trade name of the private label brand; and
489 (iii) if applicable, the trade name of the equivalent national brand.
490 (4) "Contact lens prescription verification" means a written request from a person who
491 sells contact lenses that:
492 (a) is sent to the prescribing optometrist or physician; and
493
494 (5) "Eye and its adnexa" means the human eye and all structures situated within the
495 orbit, including the conjunctiva, lids, lashes, and lacrimal system.
496 (6) "Fitting of a contact lens" means:
497 (a) the using of a keratometer to measure the human eye;
498 (b) utilizing refractive data provided by a licensed optometrist or ophthalmologist; and
499 (c) trial fitting of contact lenses, which includes a period of time for evaluation for fit
500 and performance, to determine a tentative contact lens prescription for a patient if the patient:
501 (i) has not worn contact lenses before; or
502 (ii) has changed to a different type or base curve.
503 (7) "Laser surgery" means surgery in which human tissue is cut, burned, or vaporized
504 by means of laser or ionizing radiation.
505 (8) "Ophthalmic lens" means any lens used to treat the eye and that:
506 (a) has a spherical, cylindrical, or prismatic power;
507 (b) is made pursuant to an unexpired prescription; and
508 (c) is intended to be used in eyeglasses or spectacles.
509 (9) "Optometric assistant" means an unlicensed individual:
510 (a) working under the direct and immediate supervision of a licensed optometrist; and
511 (b) engaged in specific tasks assigned by the licensed optometrist in accordance with
512 the standards and ethics of the profession.
513 (10) "Optometrist" or "optometric physician" means an individual licensed under this
514 chapter.
515 (11) "Optometry" and "practice of optometry" mean any one or any combination of the
516 following practices:
517 (a) examination of the human eye and its adnexa to detect and diagnose defects or
518 abnormal conditions;
519 (b) determination or modification of the accommodative or refractive state of the
520 human eye or its range or power of vision by administration and prescription of pharmaceutical
521 agents or the use of diagnostic instruments;
522 (c) prescription, ordering, administration, or adaptation of ophthalmic lenses, contact
523 lenses, ophthalmic devices, pharmaceutical agents, laboratory tests, or ocular exercises to
524
525 adnexa;
526 (d) display of any advertisement, circular, sign, or device offering to:
527 (i) examine the eyes;
528 (ii) fit glasses or contact lenses; or
529 (iii) adjust frames;
530 (e) removal of a foreign body from the eye or its adnexa, that is not deeper than the
531 anterior 1/2 of the cornea;
532 (f) consultation regarding the eye and its adnexa with other appropriate health care
533 providers, including referral to other appropriate health care providers; and
534 (g) a person, not licensed as an optometrist, directing a licensee under this chapter to
535 withhold or alter the eye care services the licensee has ordered.
536 (12) "Pharmaceutical agent" means any diagnostic or therapeutic drug or combination
537 of drugs that has the property of assisting in the diagnosis, prevention, treatment, or mitigation
538 of abnormal conditions or symptoms of the eye and its adnexa.
539 (13) "Physician" has the same meaning as defined in Subsection 58-67-102 (7).
540 (14) "Prescription drug" has the same definition as in Section [
541 58-17b-102 .
542 (15) "Unexpired" means a prescription that was issued:
543 (a) not more than two years prior to presentation of the prescription for an ophthalmic
544 lens; or
545 (b) in accordance with Subsection (3) for a contact lens.
546 Section 8. Section 58-17b-101 is enacted to read:
547
548
549 58-17b-101. Title.
550 This chapter is known as the "Pharmacy Practice Act."
551 Section 9. Section 58-17b-102 is enacted to read:
552 58-17b-102. Definitions.
553 In addition to the definitions in Section 58-1-102 , as used in this chapter:
554 (1) "Administering" means:
555
556 inhalation, ingestion, or by any other means, to the body of a human patient or research subject
557 by another person; or
558 (b) the placement by a veterinarian with the owner or caretaker of an animal or group
559 of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
560 means directed to the body of the animal by the owner or caretaker in accordance with written
561 or verbal directions of the veterinarian.
562 (2) "Adulterated drug or device" means a drug or device considered adulterated under
563 21 U.S.C.S. Sec. 351 (2003).
564 (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
565 the purpose of analysis.
566 (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
567 used as standards and controls in performing drug monitoring or drug screening analysis if the
568 prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
569 components, organic solvents, or inorganic buffers at a concentration not exceeding one
570 milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
571 use.
572 (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
573 the use of prescription drugs.
574 (5) "Automated pharmacy systems" includes mechanical systems which perform
575 operations or activities, other than compounding or administration, relative to the storage,
576 packaging, dispensing, or distribution of medications, and which collect, control, and maintain
577 all transaction information.
578 (6) "Beyond-use-date" means a date determined by a pharmacist and should be placed
579 on a prescription label at the time of dispensing that is intended to indicate to the patient or
580 caregiver a time beyond which the contents of the prescription are not recommended to be
581 used.
582 (7) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
583 underserved area, used for the storage and dispensing of prescription drugs, which is dependent
584 upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
585 approved by the division as the parent pharmacy.
586
587 created in Section 58-17b-201 .
588 (9) "Centralized prescription processing" means the processing by a pharmacy of a
589 request from another pharmacy to fill or refill a prescription drug order or to perform
590 processing functions such as dispensing, drug utilization review, claims adjudication, refill
591 authorizations, and therapeutic interventions.
592 (10) "Class A pharmacy" means a pharmacy that is authorized as a retail pharmacy to
593 compound or dispense a drug or dispense a device to the public under a prescription order.
594 (11) "Class B pharmacy" means a pharmacy that is authorized to provide
595 pharmaceutical care for patients in an institutional setting and whose primary purpose is to
596 provide a physical environment for patients to obtain health care services and includes closed
597 door, hospital, clinics, nuclear, branch, pharmaceutical research facilities, pharmaceutical
598 administration facilities, and sterile product preparation facilities.
599 (12) "Class C pharmacy" means a pharmacy that is authorized to engage in the
600 manufacture, production, wholesale, or distribution of drugs or devices.
601 (13) "Class D pharmacy" means a nonresident pharmacy to include any pharmacy
602 outside of Utah that is authorized to deliver drugs or devices to residents of Utah.
603 (14) "Class E pharmacy" means all other pharmacy facilities.
604 (15) "Closed door" pharmacy means a pharmacy that provides pharmaceutical care to a
605 defined and exclusive group of patients who have access to the services of the pharmacy
606 because they are treated by or have an affiliation with a specific entity including health
607 maintenance organizations and infusion companies, and does not include hospital pharmacies,
608 retail sales to the general public, or the offices of practitioners.
609 (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
610 more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
611 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
612 care functions authorized by the practitioner or practitioners under certain specified conditions
613 or limitations.
614 (17) "Collaborative pharmacy practice agreement" means a written and signed
615 agreement between one or more pharmacists and one or more practitioners that provides for
616 collaborative pharmacy practice for the purpose of drug therapy management of patients and
617
618 (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
619 labeling of a limited quantity drug, sterile product, or device:
620 (i) as the result of a practitioner's prescription order or initiative based on the
621 practitioner, patient, or pharmacist relationship in the course of professional practice;
622 (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
623 not for sale or dispensing; or
624 (iii) in anticipation of prescription drug orders based on routine, regularly observed
625 prescribing patterns.
626 (b) "Compounding" does not include:
627 (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
628 another pharmacist or pharmaceutical administration facility;
629 (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
630 dosage form which is regularly and commonly available from a manufacturer in quantities and
631 strengths prescribed by a practitioner; or
632 (iii) the preparation of a prescription drug, sterile product, or device which has been
633 withdrawn from the market for safety reasons.
634 (19) "Confidential information" has the same meaning as "protected health
635 information" under the Standards for Privacy of Individually Identifiable Health Information,
636 45 C.F.R. Parts 160 and 164.
637 (20) "Controlled substance" has the same definition as in Section 58-37-2 .
638 (21) "Device" means an instrument, apparatus, implement, machine, contrivance,
639 implant, in vitro reagent, or other similar or related article, including any component part or
640 accessory, which is required under federal or state law to be prescribed by a practitioner and
641 dispensed by a pharmacist or pharmacy intern.
642 (22) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
643 417, Sec. 3a(ff) which is incorporated by reference.
644 (23) "Dispense" means the interpretation, evaluation, and implementation of a
645 prescription drug order or device or nonprescription drug or device under a lawful order of a
646 practitioner in a suitable container appropriately labeled for subsequent administration to or use
647 by a patient, research subject, or an animal.
648
649 dispensing.
650 (25) "Drug" means:
651 (a) a substance recognized as a drug in any official compendium, or supplement
652 thereto, designated from time to time by the division in collaboration with the board for use in
653 the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals,
654 excluding nonprescription drugs or dietary supplements;
655 (b) a drug or device that is required by any applicable federal or state law or rule to be
656 dispensed on prescription only or is restricted to use by practitioners only;
657 (c) substances other than food intended to affect the structure or any function of the
658 body of humans or other animals, excluding nonprescription dietary supplements; and
659 (d) substances intended for use as a component of any substance specified in
660 Subsection (25)(a), (b), or (c).
661 (26) "Drug product equivalent" means a drug product that is designated as the
662 therapeutic equivalent of another drug product in the Approved Drug Products with
663 Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
664 of the Federal Food and Drug Administration.
665 (27) "Drug regimen review" includes the following activities:
666 (a) evaluation of the prescription drug order and patient record for:
667 (i) known allergies;
668 (ii) rational therapy-contraindications;
669 (iii) reasonable dose and route of administration; and
670 (iv) reasonable directions for use;
671 (b) evaluation of the prescription drug order and patient record for duplication of
672 therapy;
673 (c) evaluation of the prescription drug order and patient record for interactions:
674 (i) drug-drug;
675 (ii) drug-food;
676 (iii) drug-disease; and
677 (iv) adverse drug reactions; and
678 (d) evaluation of the prescription drug order and patient record for proper utilization,
679
680 (28) "Drug sample" means a prescription drug packaged in small quantities consistent
681 with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
682 be sold, and is intended to be provided to practitioners for the immediate needs of patients for
683 trial purposes or to provide the drug to the patient until a prescription can be filled by the
684 patient.
685 (29) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
686 symbol, or process attached to or logically associated with a record and executed or adopted by
687 a person with the intent to sign the record.
688 (30) "Electronic transmission" means transmission of information in electronic form or
689 the transmission of the exact visual image of a document by way of electronic equipment.
690 (31) "Extern" means a college of pharmacy student enrolled in a college coordinated
691 practical experience program in a health care setting under the supervision of a preceptor, as
692 defined in this act, and approved by a college of pharmacy.
693 (32) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
694 inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
695 under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
696 (33) "Licensed pharmacy technician" means an individual licensed with the division,
697 that may, under the supervision of a pharmacist, perform the activities involved in the
698 technician practice of pharmacy.
699 (34) "Manufacturer" means a person or business physically located in Utah licensed to
700 be engaged in the manufacturing of drugs or devices.
701 (35) (a) "Manufacturing" means:
702 (i) the production, preparation, propagation, conversion, or processing of a drug or
703 device, either directly or indirectly, by extraction from substances of natural origin or
704 independently by means of chemical or biological synthesis, or by a combination of extraction
705 and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
706 or relabeling of its container; and
707 (ii) the promotion and marketing of such drugs or devices.
708 (b) "Manufacturing" includes the preparation and promotion of commercially available
709 products from bulk compounds for resale by pharmacies, practitioners, or other persons.
710
711 pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
712 compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
713 analysis.
714 (36) "Medical order" means a lawful order of a practitioner which may include a
715 prescription drug order.
716 (37) "Medication profile" or "profile" means a record system maintained as to drugs or
717 devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
718 the profile to provide pharmaceutical care.
719 (38) "Misbranded drug or device" means a drug or device considered misbranded under
720 21 U.S.C.S. Sec. 352 (2003).
721 (39) "Nonprescription drug" means a drug which may be sold without a prescription
722 and which is labeled for use by the consumer in accordance with federal law and includes
723 homeopathic remedies.
724 (40) "Nonresident pharmacy" means any pharmacy that sells to anyone in Utah, but is
725 not physically located in Utah.
726 (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
727 (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
728 outside the state that S IS LICENSED AND IN GOOD STANDING IN ANOTHER STATE, THAT s :
729 (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a resident
730 in this state pursuant to a legally issued prescription;
731 (b) provides information to a resident of this state on drugs or devices which may
732 include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
733 or
734 (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
735 effects of drugs.
736 (43) "Patient counseling" means the written and oral communication by the pharmacist,
737 pharmacy preceptor, or pharmacy intern of information, to the patient or caregiver, in order to
738 ensure proper use of drugs, devices, and dietary supplements.
739 (44) "Pharmaceutical administration facility" means a health care facility or agency, in
740 which:
741
742 the facility or agency for administration to patients of that facility or agency;
743 (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
744 or pharmacy intern with whom the facility has established a prescription drug supervising
745 relationship under which the pharmacist or pharmacy intern provides counseling to the facility
746 or agency staff as required, and oversees drug control, accounting, and destruction; and
747 (c) prescription drugs are professionally administered in accordance with the order of a
748 practitioner by an employee or agent of the facility or agency.
749 (45) (a) "Pharmaceutical care" means carrying out the following in collaboration with a
750 prescribing practitioner, and in accordance with division rule:
751 (i) designing, implementing, and monitoring a therapeutic drug plan intended to
752 achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
753 the patient's disease;
754 (ii) eliminating or reducing a patient's symptoms; or
755 (iii) arresting or slowing a disease process.
756 (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
757 prescribing practitioner.
758 (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
759 distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
760 state.
761 (47) (a) "Pharmaceutical research facility" means a facility engaged in conducting
762 scientific research regarding drugs and their use in accordance with standard research protocols
763 and techniques, who maintains competent documentation with respect to the research, and who
764 uses prescription drugs in the conduct of the research.
765 (b) "Pharmaceutical research facility" does not include any licensed facility or clinic
766 whose primary researchers are licensed practitioners.
767 (48) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
768 engaged in the business of wholesale vending or selling of any prescription drug or device to
769 other than the consumer or user of the prescription drug or device, which the pharmaceutical
770 facility has not produced, manufactured, compounded, or dispensed.
771 (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
772
773 (i) intracompany sales;
774 (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
775 purchase or trade a prescription drug or device between hospitals or other health care facilities
776 that are under common ownership or control of the management and operation of the facilities;
777 (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
778 purchase, or trade a prescription drug or device for emergency medical reasons, or to supply
779 another pharmaceutical facility to alleviate a temporary shortage; or
780 (iv) the distribution of a prescription drug or device as a sample by representatives of a
781 manufacturer.
782 (49) "Pharmacist" means an individual licensed by this state to engage in the practice
783 of pharmacy.
784 (50) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing
785 who accepts responsibility for the operation of a pharmacy in conformance with all laws and
786 rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
787 in full and actual charge of the pharmacy and all personnel.
788 (51) "Pharmacist preceptor" means a licensed pharmacist in good standing with two or
789 more years of licensed experience whose name appears on a division list of approved
790 preceptors. The preceptor serves as a teacher, example of professional conduct, and supervisor
791 of interns in the professional practice of pharmacy.
792 (52) "Pharmacy" means any place within Utah where drugs are dispensed and
793 pharmaceutical care is provided and any place outside of Utah where drugs are dispensed and
794 pharmaceutical care is provided to residents of Utah.
795 (53) "Pharmacy benefits manager or coordinator" means a person S OR ENTITY s that
795a administers the
796 prescription drug or device portion of health insurance plans on behalf of plan sponsors, such
797 as self-insured employers, insurance companies, and health maintenance organizations, and
798 may be further defined by rule.
799 (54) "Pharmacy intern" means an individual licensed by this state to engage in practice
800 as a pharmacy intern.
801 (55) "Pharmacy technician training program" means an approved technician training
802 program providing education for pharmacy technicians.
803
804 pharmacy technician under the general supervision of a licensed pharmacist and in accordance
805 with a scope of practice as defined by division rule made in collaboration with the board.
806 (b) "Practice as a licensed pharmacy technician" does not include:
807 (i) performing a drug utilization review, prescription drug order clarification from a
808 prescriber, final review of the prescription and prescribed drug prepared for dispensing,
809 dispensing of the drug, or counseling a patient with respect to a prescription drug;
810 (ii) counseling regarding nonprescription drugs and dietary supplements unless
811 delegated by the supervising pharmacist; or
812 (iii) receiving new prescription drug orders when communicating telephonically or
813 electronically unless the original information is recorded so the pharmacist may review the
814 prescription drug order as transmitted.
815 (57) "Practice of pharmacy" includes the following:
816 (a) providing pharmaceutical care;
817 (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
818 practice agreement;
819 (c) compounding, packaging, labeling, dispensing, administering, and the coincident
820 distribution of prescription drugs or devices, provided that the administration of a prescription
821 drug or device is:
822 (i) pursuant to a lawful order of a practitioner when one is required by law; and
823 (ii) in accordance with written guidelines or protocols:
824 (A) established by the licensed facility in which the prescription drug or device is to be
825 administered on an inpatient basis; or
826 (B) approved by the division, in collaboration with the board and the Physician's
827 Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
828 administered on an outpatient basis solely by a licensed pharmacist;
829 (d) participating in drug utilization review;
830 (e) ensuring proper and safe storage of drugs and devices;
831 (f) maintaining records of drugs and devices in accordance with state and federal law
832 and the standards and ethics of the profession;
833 (g) providing information on drugs or devices, which may include advice relating to
834
835 (h) providing drug product equivalents;
836 (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
837 technicians;
838 (j) providing patient counseling, including adverse and therapeutic effects of drugs;
839 (k) providing emergency refills as defined by rule;
840 (l) telepharmacy; and
841 (m) formulary management intervention.
842 (58) "Practice of telepharmacy" means the practice of pharmacy through the use of
843 telecommunications and information technologies.
844 (59) "Practice of telepharmacy across state lines" means the practice of pharmacy
845 through the use of telecommunications and information technologies that occurs when the
846 patient is physically located within one jurisdiction and the pharmacist is located in another
847 jurisdiction.
848 (60) "Practitioner" means an individual currently licensed, registered, or otherwise
849 authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of
850 professional practice.
851 (61) "Prescription" means an order:
852 (a) issued by a licensed practitioner:
853 (i) orally, in writing, by telephone, facsimile transmission, computer, or other
854 electronic means of communication as defined by division rule;
855 (ii) in the course of the practitioner's professional practice; or
856 (iii) by collaborative pharmacy practice agreement; and
857 (b) for a controlled substance, other prescription drug, or device with the intent that the
858 controlled substance, prescription drug, or device will be used by a patient or an animal.
859 (62) "Prescription drug or device" means:
860 (a) a legend drug or device; or
861 (b) a drug or device that is required by an applicable federal or state law or rule to be
862 dispensed on prescription only or is restricted to use by practitioners only.
863 (63) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugs
864 and devices to the general public.
865
866 with this chapter.
867 (65) "Supervising pharmacist" means a pharmacist who is overseeing the operation of
868 the pharmacy during a given day or shift.
869 (66) "Supportive personnel" means unlicensed individuals who:
870 (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
871 pharmacy technician in nonjudgmental duties not included in the definition of the practice of
872 pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
873 those duties may be further defined by division rule adopted in collaboration with the board;
874 and
875 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
876 collaboration with the board.
877 (67) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
878 (68) "Unprofessional conduct" is as defined in Sections 58-1-501 and 58-17b-502 and
879 may be further defined by rule.
880 (69) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
881 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
882 for animals.
883 Section 10. Section 58-17b-103 is enacted to read:
884 58-17b-103. Administrative inspections.
885 (1) The division may for the purpose of ascertaining compliance with the provisions of
886 this chapter, require a self-audit or enter and inspect the business premises of a person:
887 (a) licensed under Part 3, Licensing; or
888 (b) who is engaged in activities that require a license under Part 3, Licensing.
889 (2) Before conducting an inspection under Subsection (1), the division shall, after
890 identifying the person in charge:
891 (a) give proper identification;
892 (b) request to see the applicable license or licenses;
893 (c) describe the nature and purpose of the inspection; and
894 (d) provide upon request, the authority of the division to conduct the inspection and the
895 penalty for refusing to permit the inspection as provided in Section 58-17b-504 .
896
897 the requirements of Subsection (2):
898 (a) examine any record, prescription, order, drug, device, equipment, machine,
899 electronic device or media, or area related to activities for which a license has been issued or is
900 required by Part 3, Licensing, for the purpose of ascertaining compliance with the applicable
901 provisions of this chapter;
902 (b) take a drug or device for further analysis if considered necessary;
903 (c) temporarily seize a drug or device which is suspected to be adulterated, misbranded,
904 outdated, or otherwise in violation of this chapter, pending an adjudicative proceeding on the
905 matter;
906 (d) box and seal drugs suspected to be adulterated, outdated, misbranded, or otherwise
907 in violation of this chapter; and
908 (e) dispose of or return any drug or device obtained under this Subsection (3) in
909 accordance with procedures established by division rule.
910 (4) An inspection conducted under Subsection (1) shall be during regular business
911 hours.
912 (5) If upon inspection, the division concludes that a person has violated the provisions
913 of this chapter or Chapter 37, Utah Control Substances Act, or any rule or order issued with
914 respect to those chapters, and that disciplinary action is appropriate, the director or the
915 director's designee shall promptly issue a fine or citation to the licensee in accordance with
916 Section 58-17b-504 .
917 Section 11. Section 58-17b-201 is enacted to read:
918
919 58-17b-201. Board -- Membership -- Qualifications -- Terms.
920 (1) There is created the Utah State Board of Pharmacy consisting of five pharmacists,
921 one pharmacy technician, and one member of the general public.
922 (a) The public member of the board shall be a Utah resident who:
923 (i) is 21 years of age or older;
924 (ii) has never been licensed to engage in the practice of pharmacy;
925 (iii) has never been the spouse of a person licensed to engage in the practice of
926 pharmacy;
927
928 (v) has never engaged in any activity directly related to the practice of pharmacy.
929 (b) The licensed pharmacist and licensed pharmacy technician members of the board
930 shall:
931 (i) have been Utah residents continuously for at least three years;
932 (ii) have at least five years experience in the practice of pharmacy in good standing
933 with the division in Utah after licensure; and
934 (iii) maintain licensure in good standing to engage in the practice of pharmacy or
935 practice as a pharmacy technician in Utah for the duration of the appointment.
936 (2) The board shall be appointed and serve in accordance with Section 58-1-201 .
937 (3) The duties and responsibilities of the board are in accordance with Sections
938 58-1-202 and 58-1-203 . In addition, the board shall designate an appropriate member on a
939 permanent or rotating basis to:
940 (a) assist the division in reviewing complaints concerning the unlawful or
941 unprofessional conduct of a licensee; and
942 (b) advise the division in its investigation of these complaints.
943 (4) A board member who has, under Subsection (3), reviewed a complaint or advised
944 in its investigation may be disqualified from participating with the board when the board serves
945 as a presiding officer in an adjudicative proceeding concerning the complaint.
946 (5) A board member may be removed in accordance with Subsection 58-1-201 (2)(e) or
947 upon one of the following grounds:
948 (a) refusal or inability for any reason of a board member to perform his duties as a
949 member of the Board in an efficient, responsible, and professional manner;
950 (b) misuse of appointment to obtain personal, pecuniary, or material gain or advantage
951 for himself or another through such appointment; or
952 (c) violation of the laws governing the practice of pharmacy or Chapter 37, Utah
953 Controlled Substances Act.
954 Section 12. Section 58-17b-301 is enacted to read:
955
956 58-17b-301. License required -- License classifications for individuals.
957 (1) A license is required to engage in the practice of pharmacy, telepharmacy, or the
958
959 58-17b-309 .
960 (2) The division shall issue to an individual who qualifies under this chapter a license
961 in the classification of:
962 (a) pharmacist;
963 (b) pharmacy intern; or
964 (c) pharmacy technician.
965 Section 13. Section 58-17b-302 is enacted to read:
966 58-17b-302. License classifications of pharmacy facilities.
967 (1) A license is required to act as a pharmacy, except as specifically exempted from
968 licensure under Section 58-1-307 .
969 (2) The division shall issue a pharmacy license to a facility that qualifies under this
970 chapter in the classification of a:
971 (a) class A pharmacy;
972 (b) class B pharmacy;
973 (c) class C pharmacy;
974 (d) class D pharmacy; or
975 (e) class E pharmacy.
976 (3) Each place of business shall require a separate license. If multiple pharmacies exist
977 at the same address, a separate license shall be required for each pharmacy.
978 (4) The division may further define or supplement the classifications of pharmacies.
979 The division may impose restrictions upon classifications to protect the public health, safety,
980 and welfare.
981 (5) Each pharmacy shall have a pharmacist-in-charge, except as otherwise provided by
982 rule.
983 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy,
984 the pharmacist-in-charge and the owner or owners of the pharmacy shall be responsible for all
985 activities of the pharmacy, regardless of the form of the business organization.
986 (7) Any facility holding a pharmacy license prior to July 1, 2004, shall be converted
987 from the classification of license currently held to the appropriate classification established
988 under this chapter upon their next renewal or reinstatement of licensure, in accordance with a
989
990 Section 14. Section 58-17b-303 is enacted to read:
991 58-17b-303. Qualifications for licensure as a pharmacist.
992 (1) Each applicant for licensure as a pharmacist shall:
993 (a) submit an application in a form prescribed by the division;
994 (b) pay a fee as determined by the department under Section 63-38-3.2 ;
995 (c) produce satisfactory evidence of good moral character as it relates to the applicant's
996 ability to practice pharmacy;
997 (d) complete a criminal background check and be free from criminal convictions as
998 required by Section 58-17b-307 , or as described in Section 58-1-501 ;
999 (e) have no physical or mental condition of a nature which prevents the applicant from
1000 engaging in the practice of pharmacy with reasonable skill, competency, and safety to the
1001 public;
1002 (f) have graduated and received a professional entry degree from a school or college of
1003 pharmacy which is accredited by the American Council on Pharmaceutical Education;
1004 (g) have completed an internship meeting standards established by division rule made
1005 in collaboration with the board; and
1006 (h) have successfully passed examinations required by division rule made in
1007 collaboration with the board.
1008 (2) Each applicant for licensure as a pharmacist whose pharmacy education was
1009 completed at a foreign pharmacy school shall, in addition to the requirements under
1010 Subsections (1)(a) through (e), (g), and (h), obtain a certification of equivalency from a
1011 credentialing agency required by division rule made in collaboration with the board.
1012 (3) Each applicant for a license by endorsement as a pharmacist under this section
1013 shall:
1014 (a) submit a written application in the form prescribed by the division;
1015 (b) pay the fee determined by the department under Section 63-38-3.2 ;
1016 (c) be of good moral character as required of applicants for licensure as pharmacists
1017 under Subsection (1);
1018 (d) complete a criminal background check and be free from criminal convictions as
1019 required by Section 58-17b-307 , or as otherwise described in Section 58-1-501 ;
1020
1021 engaging in the practice of pharmacy with reasonable skill, competency, and safety to the
1022 public;
1023 (f) have lawfully practiced as a licensed pharmacist a minimum of 2,000 hours in the
1024 four years immediately preceding the date of application;
1025 (g) produce satisfactory evidence of completing the professional education required
1026 under Subsection (1);
1027 (h) be currently licensed in good standing as a pharmacist in another state, territory, or
1028 possession of the United States;
1029 (i) produce satisfactory evidence that the examination requirements are or were at the
1030 time the license was issued, equal to those of this state; and
1031 (j) pass the jurisprudence examination prescribed by division rule made in
1032 collaboration with the board.
1033 Section 15. Section 58-17b-304 is enacted to read:
1034 58-17b-304. Qualifications for licensure of pharmacy intern.
1035 Each applicant for licensure as a pharmacy intern shall:
1036 (1) submit an application in a form prescribed by the division;
1037 (2) pay a fee determined by the department under Section 63-38-3.2 ;
1038 (3) produce satisfactory evidence of good moral character as it relates to the applicant's
1039 ability to practice pharmacy;
1040 (4) complete a criminal background check and be free from criminal convictions as
1041 required by Section 58-17b-307 , or as otherwise described in Section 58-1-501 ;
1042 (5) have no physical or mental condition of a nature which prevents the applicant from
1043 engaging in the practice of pharmacy with reasonable skill, competency, and safety to the
1044 public;
1045 (6) meet the preliminary educational qualifications required by division rule made in
1046 collaboration with the board; and
1047 (7) meet one of the following educational criteria:
1048 (a) be a current pharmacy student, a resident, or fellow in a program approved by
1049 division rule in collaboration with the board;
1050 (b) have graduated and received a pharmacy degree from a school or college of
1051
1052 (c) have graduated from a foreign pharmacy school and received certification of
1053 equivalency from a credentialing agency approved by the division rule in collaboration with the
1054 board.
1055 Section 16. Section 58-17b-305 is enacted to read:
1056 58-17b-305. Qualifications for licensure of pharmacy technician.
1057 (1) Each applicant for licensure as a pharmacy technician shall:
1058 (a) submit an application in a form prescribed by the division;
1059 (b) pay a fee determined by the department under Section 63-38-3.2 ;
1060 (c) produce satisfactory evidence of good moral character as it relates to the applicant's
1061 ability to practice pharmacy;
1062 (d) complete a criminal background check and be free from criminal convictions as
1063 required by Section 58-17b-307 , or as otherwise permitted by Section 58-1-501 ;
1064 (e) have no physical or mental condition of a nature which prevents the applicant from
1065 engaging in practice as a pharmacy technician with reasonable skill, competency, and safety to
1066 the public;
1067 (f) have completed a board approved program and curriculum of education and
1068 training, meeting standards established by division rule made in collaboration with the board;
1069 and
1070 (g) successfully complete the examinations requirement within the time periods
1071 established by division rule made in collaboration with the board.
1072 (2) A pharmacist whose license has been denied, revoked, suspended, or restricted for
1073 disciplinary purposes shall not be eligible to be a licensed pharmacy technician while on
1074 probation with the division.
1075 Section 17. Section 58-17b-306 is enacted to read:
1076 58-17b-306. Qualifications for licensure as a pharmacy.
1077 (1) Each applicant for licensure under this section, except for those applying for a class
1078 D license, shall:
1079 (a) submit a written application in the form prescribed by the division;
1080 (b) pay a fee as determined by the department under Section 63-38-3.2 ;
1081 (c) satisfy the division that the applicant, and each owner, officer, or manager of the
1082
1083 duties and responsibilities of a licensee under this section indicates there is cause to believe
1084 that issuing a license to the applicant is inconsistent with the interest of the public's health,
1085 safety, or welfare;
1086 (d) demonstrate the licensee's operations will be in accordance with all federal, state,
1087 and local laws relating to the type of activity engaged in by the licensee, including regulations
1088 of the Federal Drug Enforcement Administration and Food and Drug Administration;
1089 (e) maintain operating standards established by division rule made in collaboration
1090 with the board; and
1091 (f) acknowledge the division's authority to inspect the licensee's business premises
1092 pursuant to Section 58-17b-103 .
1093 (2) Each applicant applying for a class D license shall:
1094 (a) submit a written application in the form prescribed by the division;
1095 (b) pay a fee as determined by the department under Section 63-38-3.2 ;
1096 (c) present to the division verification of licensure in the state where physically located
1097 and verification that such license is in good standing;
1098 (d) provide a statement of the scope of pharmacy services that will be provided and a
1099 detailed description of the protocol as described by rule by which pharmacy care will be
1100 provided, including any collaborative practice arrangements with other health care
1101 practitioners;
1102 (e) sign an affidavit attesting that any healthcare practitioners employed by the
1103 applicant and physically located in Utah have the appropriate license issued by the division and
1104 in good standing; and
1105 (f) sign an affidavit attesting that the applicant will abide by the pharmacy laws and
1106 regulations of the jurisdiction in which the S [
1107 (3) Each license issued under this section shall be issued for a single, specific address,
1108 and is not transferable or assignable.
1109 Section 18. Section 58-17b-307 is enacted to read:
1110 58-17b-307. Qualification for licensure -- Criminal background checks.
1111 (1) An applicant for licensure under this chapter shall submit fingerprint cards in a
1112 form acceptable to the division at the time the license application is filed and shall consent to a
1113
1114 Bureau of Investigation regarding the application.
1115 (2) The division shall request the Department of Public Safety to complete a Federal
1116 Bureau of Investigation criminal background check for each applicant through the national
1117 criminal history system (NCIC) or any successor system.
1118 (3) If convicted of one or more felonies, an applicant must receive an absolute
1119 discharge from the sentences for all felony convictions five or more years prior to the date of
1120 filing an application for licensure under this chapter.
1121 (4) For purposes of conducting the criminal background check required in Subsection
1122 (1), the division shall have direct access to criminal background information maintained
1123 pursuant to Title 53, Chapter 10, Part 2, Bureau of Criminal Identification.
1124 (5) Any new pharmacist, pharmacy intern, or pharmacy technician license issued under
1125 this section shall be conditional, pending completion of the criminal background check.
1126 Notwithstanding Title 63, Chapter 46b, Administrative Procedures Act, if the criminal
1127 background check discloses the applicant has failed to accurately disclose a criminal history,
1128 the license shall be immediately and automatically revoked upon notice to the licensee.
1129 (6) Any person whose conditional license has been revoked under Subsection (5) shall
1130 be entitled to a postrevocation hearing to challenge the revocation. The hearing shall be
1131 conducted in accordance with Title 63, Chapter 46b, Administrative Procedures Act.
1132 Section 19. Section 58-17b-308 is enacted to read:
1133 58-17b-308. Term of license -- Expiration -- Renewal.
1134 (1) Except as provided in Subsection (2), each license issued under this chapter shall be
1135 issued in accordance with a two-year renewal cycle established by rule. A renewal period may
1136 be extended or shortened by as much as one year to maintain established renewal cycles or to
1137 change an established renewal cycle. Each license automatically expires on the expiration date
1138 shown on the license unless renewed by the licensee in accordance with Section 58-1-308 .
1139 (2) The duration of a pharmacy intern license may be no longer than:
1140 (a) one year for a license issued under Subsection 58-17b-304 (7)(b) or (c); or
1141 (b) four years for a license issued under Subsection 58-17b-304 (7)(a).
1142 (3) A pharmacy intern license issued under this chapter may not be renewed, but may
1143 be extended by the division in collaboration with the board.
1144
1145 58-17b-309. Exemptions from licensure.
1146 (1) In addition to the exemptions from licensure in Section 58-1-307 , the following
1147 individuals may engage in the acts or practices described in this Subsection (1) without being
1148 licensed under this chapter:
1149 (a) a person selling contact lenses in accordance with Section 58-16a-801 ; and
1150 (b) an individual engaging in the practice of pharmacy technician under the direct
1151 personal supervision of a pharmacist while making satisfactory progress in an approved
1152 program as defined in division rule.
1153 (2) In accordance with Subsection 58-1-303 (1)(a), an individual exempt under
1154 Subsection (1)(b) must take all examinations as required by division rule following completion
1155 of an approved curriculum of education, within the required time frame. This exemption
1156 expires immediately upon notification of a failing score of an examination, and the individual
1157 may not continue working as a pharmacy technician even under direct supervision.
1158 Section 21. Section 58-17b-310 is enacted to read:
1159 58-17b-310. Continuing education.
1160 The division in collaboration with the board may establish by rule continuing education
1161 requirements for each classification of licensure under this chapter.
1162 Section 22. Section 58-17b-401 is enacted to read:
1163
1164 58-17b-401. Grounds for denial of licensure -- Disciplinary proceedings.
1165 Grounds for the following action regarding a license issued under this chapter shall be
1166 in accordance with Section 58-1-401 :
1167 (1) refusal to issue a license to an applicant;
1168 (2) refusal to renew the license of a licensee;
1169 (3) to revoke, suspend, restrict, or place on probation the license of a licensee;
1170 (4) to issue a public or private reprimand to a licensee;
1171 (5) to issue cease and desist orders; and
1172 (6) to issue an administrative fine or citation.
1173 Section 23. Section 58-17b-501 is enacted to read:
1174
1175
1176 "Unlawful conduct" includes:
1177 (1) knowingly preventing or refusing to permit any authorized agent of the division to
1178 conduct an inspection pursuant to Section 58-17b-103 ;
1179 (2) failing to deliver the license, permit, or certificate to the division upon demand, if it
1180 has been revoked, suspended, or refused;
1181 (3) (a) using the title "pharmacist," "druggist," "pharmacy intern," "pharmacy
1182 technician," or any term having similar meaning, except by a person licensed as a pharmacist,
1183 pharmacy intern, or pharmacy technician; or
1184 (b) conducting or transacting business under a name which contains, as part of that
1185 name, the words "drugstore", "pharmacy", "drugs", "medicine store", "medicines", "drug shop",
1186 "apothecary", "prescriptions", or any other term having a similar meaning, or in any manner
1187 advertising, otherwise describing, or referring to the place of the conducted business or
1188 profession, unless the place is a pharmacy issued a license by the division, except any
1189 establishment selling nonprescription drugs and supplies may display signs bearing the words
1190 "packaged drugs", "drug sundries", or "nonprescription drugs", and is not considered to be a
1191 pharmacy or drugstore by reason of the display;
1192 (4) buying, selling, causing to be sold, or offering for sale, any drug or device which
1193 bears, or the package bears or originally did bear, the inscription "sample", "not for resale", "for
1194 investigational or experimental use only", or other similar words, except when a cost is
1195 incurred in the bona fide acquisition of an investigational or experimental drug;
1196 (5) using to his own advantages or revealing to anyone other than the division, board,
1197 and its authorized representatives, or to the courts, when relevant to any judicial or
1198 administrative proceeding under this chapter, any information acquired under authority of this
1199 chapter or concerning any method of process which is a trade secret;
1200 (6) procuring or attempting to procure any drug for himself or to have someone else
1201 procure or attempt to procure any drug:
1202 (a) by fraud, deceit, misrepresentation, or subterfuge;
1203 (b) by forgery or alteration of a prescription or any written order;
1204 (c) by concealment of a material fact;
1205 (d) by use of a false statement in any prescription, chart, order, or report; or
1206
1207 (7) filling, refilling, or advertising the filling or refilling of prescriptions for any
1208 consumer or patient residing in this state if the person is not licensed:
1209 (a) under this chapter; or
1210 (b) in the state from which he is dispensing;
1211 (8) requiring any employed pharmacist, pharmacy intern, pharmacy technician, or
1212 authorized supportive personnel to engage in any conduct in violation of this chapter;
1213 (9) being in possession of a prescription drug for any unlawful purpose;
1214 (10) dispensing a prescription drug to anyone who does not have a prescription from a
1215 practitioner or to anyone who he knows or should know is attempting to obtain drugs by fraud
1216 or misrepresentation;
1217 (11) selling, dispensing, or otherwise trafficking in prescription drugs when not
1218 licensed to do so or when not exempted from licensure; and
1219 (12) using a prescription drug or controlled substance for himself that was not lawfully
1220 prescribed for him by a practitioner.
1221 Section 24. Section 58-17b-502 is enacted to read:
1222 58-17b-502. Unprofessional conduct.
1223 "Unprofessional conduct" includes:
1224 (1) willfully deceiving or attempting to deceive the division, the board, or their agents
1225 as to any relevant matter regarding compliance under this chapter;
1226 (2) (a) paying rebates to practitioners or any other health care providers, or entering
1227 into any agreement with a medical practitioner or any other person for the payment or
1228 acceptance of compensation or its economic equivalent for recommending the professional
1229 services of either party, except as allowed under Subsection (2)(b); and
1230 (b) price discounts conditional upon volume purchases are not prohibited under
1231 Subsection (2)(a);
1232 (3) misbranding or adulteration of any drug or device or the sale, distribution, or
1233 dispensing of any outdated, misbranded, or adulterated drug or device;
1234 (4) engaging in the sale or purchase of drugs or devices that are samples or packages
1235 bearing the inscription "sample" or "not for resale" or similar words or phrases;
1236 (5) accepting back and redistributing of any unused drug, or a part of it, after it has left
1237
1238 manufacturer's sealed container as defined in rule, except as provided in Section 58-17b-503 ;
1239 (6) being employed as a pharmacist, pharmacy intern, or pharmacy technician, or
1240 sharing or receiving compensation in any form arising out of an act incidental to professional
1241 activities in the course of which any person requires him to engage in any aspect of the practice
1242 of pharmacy in violation of this chapter;
1243 (7) violating Federal Title II, P.L. 91, Controlled Substances Act, or Title 58, Chapter
1244 37, Utah Controlled Substances Act, or rules and regulations adopted under either act;
1245 (8) requiring or permitting pharmacy interns or technicians to engage in activities
1246 outside the scope of practice for their respective license classifications as defined in this
1247 chapter and division rules made in collaboration with the board, or beyond an individual's
1248 scope of training and ability;
1249 (9) administering without appropriate training as defined by rule:
1250 (a) written guidelines or protocols of a practitioner or in conflict with such guidelines
1251 or protocols; or
1252 (b) a lawful order, when one is required by law;
1253 (10) disclosing confidential patient information in violation of the provisions of the
1254 Health Insurance Portability and Accountability Act of 1996 or other applicable law;
1255 (11) engaging in the practice of pharmacy without a licensed pharmacist designated as
1256 the pharmacist-in-charge;
1257 (12) failing to report to the division any adverse action taken by another licensing
1258 jurisdiction, government agency, law enforcement agency, or court for conduct that would
1259 constitute grounds for action as defined in this section;
1260 (13) preparing as a pharmacist or pharmacy intern, a prescription drug for sale to
1261 another pharmacist or pharmaceutical facility; and
1262 (14) preparing as a pharmacist or pharmacy intern, a prescription drug in a dosage form
1263 which is regularly and commonly available from a manufacturer in quantities and strengths
1264 prescribed by a practitioner.
1265 Section 25. Section 58-17b-503 is enacted to read:
1266 58-17b-503. Exception to unprofessional conduct.
1267 (1) For purposes of this section:
1268
1269 nursing care facility or a small health care facility under Title 26, Chapter 21, Health Care
1270 Facility Licensing and Inspection Act.
1271 (b) "Nursing care facility" has the same definition as in Section 26-21-2 .
1272 (c) "Unit pack" means a single dose-single drug package which identification indicates
1273 the lot number and expiration date for the drug.
1274 (2) Notwithstanding the provisions of Subsection 58-17b-502 (5), a pharmacist may
1275 accept back and redistribute any unused drug, or a part of it, after it has left the premises of the
1276 pharmacy if:
1277 (a) the drug was prescribed to a patient in a nursing care facility, a ICFMR, or state
1278 prison facility, county jail, or state hospital;
1279 (b) the drug was stored under the supervision of a licensed health care provider
1280 according to manufacturer recommendations;
1281 (c) the drug is in a unit pack or in the manufacturer's sealed container;
1282 (d) the drug was returned to the original dispensing pharmacy;
1283 (e) the drug was initially dispensed by a licensed pharmacist or licensed pharmacy
1284 intern; and
1285 (f) accepting back and redistribution of the drug complies with Federal Food and Drug
1286 Administration and Drug Enforcement Administration regulations.
1287 Section 26. Section 58-17b-504 is enacted to read:
1288 58-17b-504. Penalty for unlawful or unprofessional conduct -- Fines -- Citations.
1289 (1) Any person who violates the unlawful conduct provision defined in Subsection
1290 58-1-501 (1)(a)(i) and Subsections 58-17b-501 (7) and (11) is guilty of a third degree felony.
1291 (2) Any person who violates the unlawful conduct provisions defined in Subsection
1292 58-1-501 (1)(a)(ii), Subsections 58-1-501 (1)(b) through (e) and Section 58-17b-501 , except
1293 Subsections 58-17b-501 (7) and (11), is guilty of a class A misdemeanor.
1294 (3) (a) Subject to Subsection (5), the division may assess administrative penalties in
1295 accordance with the provisions of Section 58-17b-401 for acts of unprofessional or unlawful
1296 conduct or any other appropriate administrative action in accordance with the provisions of
1297 Section 58-17b-401 .
1298 (b) An administrative penalty imposed pursuant to this section shall be deposited in the
1299
1300 and enforcement as provided in Section 58-12b-505 .
1301 (4) If a licensee has been convicted of violating Section 58-17b-501 prior to an
1302 administrative finding of a violation of the same section, the licensee may not be assessed an
1303 administrative fine under this chapter for the same offense for which the conviction was
1304 obtained.
1305 (5) (a) If upon inspection or investigation, the division concludes that a person has
1306 violated the provisions of Section 58-17b-501 , 58-17b-502 , or Chapter 37, Utah Controlled
1307 Substances Act, or any rule or order issued with respect to these provisions, and that
1308 disciplinary action is appropriate, the director or the director's designee from within the
1309 division shall promptly issue a citation to the person according to this chapter and any pertinent
1310 rules, attempt to negotiate a stipulated settlement, or notify the person to appear before an
1311 adjudicative proceeding conducted under Title 63, Chapter 46b, Administrative Procedures
1312 Act.
1313 (b) Any person who is in violation of the provisions of Section 58-17b-501 ,
1314 58-17b-502 , or Chapter 37, Utah Controlled Substances Act, or any rule or order issued with
1315 respect to these provisions, as evidenced by an uncontested citation, a stipulated settlement, or
1316 by a finding of violation in an adjudicative proceeding, may be assessed a fine pursuant to this
1317 Subsection (5) of up to $10,000 per single violation or up to $2,000 per day of ongoing
1318 violation, whichever is greater, in accordance with a fine schedule established by rule, and
1319 may, in addition to or in lieu of, be ordered to cease and desist from violating the provisions of
1320 Section 58-17b-501 , 58-17b-502 , or Chapter 37, Utah Controlled Substances Act, or any rule
1321 or order issued with respect to these provisions.
1322 (c) Except for an administrative fine and a cease and desist order, the licensure
1323 sanctions cited in Section 58-17b-401 may not be assessed through a citation.
1324 (d) Each citation shall be in writing and specifically describe with particularity the
1325 nature of the violation, including a reference to the provision of the chapter, rule, or order
1326 alleged to have been violated. The citation shall clearly state that the recipient must notify the
1327 division in writing within 20 calendar days of service of the citation if the recipient wishes to
1328 contest the citation at a hearing conducted under Title 63, Chapter 46b, Administrative
1329 Procedures Act. The citation shall clearly explain the consequences of failure to timely contest
1330
1331 in the citation.
1332 (e) Each citation issued under this section, or a copy of each citation, may be served
1333 upon any person whom a summons may be served:
1334 (i) in accordance with the Utah Rules of Civil Procedure;
1335 (ii) personally or upon the person's agent by a division investigator or by any person
1336 specially designated by the director; or
1337 (iii) by mail.
1338 (f) If within 20 calendar days from the service of a citation, the person to whom the
1339 citation was issued fails to request a hearing to contest the citation, the citation becomes the
1340 final order of the division and is not subject to further agency review. The period to contest the
1341 citation may be extended by the division for cause.
1342 (g) The division may refuse to issue or renew, suspend, revoke, or place on probation
1343 the license of a licensee who fails to comply with the citation after it becomes final.
1344 (h) The failure of an applicant for licensure to comply with a citation after it becomes
1345 final is a ground of denial of license.
1346 (i) No citation may be issued under this section after the expiration of six months
1347 following the occurrence of any violation.
1348 Section 27. Section 58-17b-505 is enacted to read:
1349 58-17b-505. Educational and enforcement fund.
1350 (1) The director may use the money collected pursuant to Section 58-17b-504 for the
1351 following purposes:
1352 (a) education and training of licensees under this chapter;
1353 (b) enforcement of this chapter by:
1354 (i) investigating unprofessional or unlawful conduct;
1355 (ii) providing legal representation to the division when legal action is taken against a
1356 person engaging in unprofessional or unlawful conduct;
1357 (iii) monitoring compliance of renewal requirement; and
1358 (iv) education and training of division staff and board members.
1359 (2) All funding for the purposes listed in Subsection (1) is nonlapsing.
1360 (3) Any penalty which is not paid may be collected by the director by either referring
1361
1362 which the person against whom the penalty is imposed resides or in the county where the office
1363 of the director is located.
1364 (4) Any county attorney or the attorney general of the state is to provide legal
1365 assistance and advice to the director in any action to collect the penalty. In any action brought
1366 to enforce the provisions of this section, reasonable attorney's fees and costs shall be awarded
1367 in which the person against whom the penalty is imposed resides or in the county where the
1368 office of the director is located.
1369 Section 28. Section 58-17b-506 is enacted to read:
1370 58-17b-506. Petitioning for reinstatement of licensure.
1371 Any person whose license to practice pharmacy in this state has been revoked,
1372 suspended, or surrendered voluntarily or by action of the division, shall have the right at
1373 reasonable intervals, to petition the division for reinstatement of such license. Such petition
1374 shall be made in writing and in the form prescribed by the division. Upon investigation and
1375 hearing, the division may, in its discretion, grant or deny such petition, or it may modify its
1376 original finding to reflect any circumstances that have changed sufficiently to warrant such
1377 modifications. The division, also at its discretion, may require such person to pass an
1378 examination or examinations for reentry into the practice of pharmacy.
1379 Section 29. Section 58-17b-601 is enacted to read:
1380
1381 58-17b-601. General operating standards.
1382 (1) (a) The division shall make rules relating to the operations and conduct of facilities,
1383 individuals, and entities which are regulated under this chapter, to protect the public health,
1384 safety, and welfare.
1385 (b) The rules shall be consistent with the regulations of the Federal Food and Drug
1386 Administration and Drug Enforcement Administration, this chapter, and all other laws relating
1387 to activities and persons regulated under this chapter.
1388 (2) (a) This chapter does not prevent, restrict, or in any other manner interfere with the
1389 sale of nonprescription drugs.
1390 (b) The division may not make any rules under this chapter that require nonprescription
1391 drugs to be sold by a licensed pharmacist or only in a pharmaceutical facility.
1392
1393 pharmacy.
1394 Section 30. Section 58-17b-602 is enacted to read:
1395 58-17b-602. Prescription orders -- Information required -- Alteration -- Labels --
1396 Signatures.
1397 (1) The minimum information that shall be included in a prescription order and may be
1398 defined by rule is:
1399 (a) the prescriber's name, address, and telephone number, and, if the order is for a
1400 controlled substance, the patient's age and the prescriber's DEA number;
1401 (b) the patient's name and address or, in the case of an animal, name of the owner and
1402 species of the animal;
1403 (c) the date of issuance;
1404 (d) the name of the medication or device prescribed and dispensing instructions, if
1405 necessary;
1406 (e) the directions for the use of the prescription, if appropriate, for the patient or
1407 animal, any refill, special labeling, and other instructions;
1408 (f) the prescriber's signature if the prescription order is written;
1409 (g) if an electronically transmitted prescription order, prescribing practitioner's
1410 electronic signature; and
1411 (h) if a hard copy prescription order generated from electronic media, prescribing
1412 practitioner's electronic or manual signature.
1413 (2) The requirement of Subsection (1)(a) does not apply to prescription orders
1414 dispensed for inpatients by hospital pharmacies if the prescriber is a current member of the
1415 hospital staff and the prescription order is on file in the patient's medical record.
1416 (3) The prescription order, except for controlled substance II, may be dispensed by
1417 pharmacists or pharmacy interns upon an oral prescription of a practitioner, if the oral
1418 prescription is promptly reduced to writing.
1419 (4) (a) A pharmacist or pharmacy intern may not dispense or compound any
1420 prescription of a practitioner if it shows evidence of alteration, erasure, or addition by any
1421 person other than the person writing the prescription, except under Subsection (4)(b).
1422 (b) A pharmacist or pharmacy intern dispensing or compounding the prescription may
1423
1424 additions on the prescription required by law or necessitated in the compounding and
1425 dispensing procedures.
1426 (5) Each drug dispensed shall have a label securely affixed to the container indicating
1427 the following minimum information:
1428 (a) the name, address, and telephone number of the pharmacy;
1429 (b) the serial number of the prescription as assigned by the dispensing pharmacy;
1430 (c) the filling date of the prescription or its last dispensing date;
1431 (d) the name of the patient, or in the case of an animal, name of the owner and species
1432 of the animal;
1433 (e) the name of the prescriber;
1434 (f) the directions for use and cautionary statements, if any, which are contained in the
1435 prescription order or are needed;
1436 (g) the trade, generic, or chemical name, amount dispensed and strength of dosage
1437 form, but if multiple ingredient products with established proprietary or nonproprietary names
1438 are prescribed, those products' names may be used; and
1439 (h) the beyond use date.
1440 (6) If the prescriber specifically indicates the name of the prescription product should
1441 not appear on the label, then the trade, generic, or chemical name and strength of dosage form
1442 may not be included.
1443 Section 31. Section 58-17b-603 is enacted to read:
1444 58-17b-603. Identification of pharmacy personnel.
1445 (1) All individuals employed in a pharmacy facility having any contact with the public
1446 or patients receiving services from that pharmacy facility shall wear on their person a clearly
1447 visible and readable identification showing the individual's name and position.
1448 (2) When communicating by any means, written, verbal, or electronic, pharmacy
1449 personnel must identify themselves as to licensure classification.
1450 Section 32. Section 58-17b-604 is enacted to read:
1451 58-17b-604. Medication profiles.
1452 (1) Each pharmacy shall establish a medication profile system for pharmacy patients
1453 according to the standards established by division rules made in collaboration with the board.
1454
1455 (2) The pharmacy shall maintain the medication profile for any pharmacy patient who
1456 expresses a desire for that professional service.
1457 (3) The pharmacy may charge an appropriate professional fee for this service and for
1458 copying or providing information in the medication profile to another authorized person.
1459 (4) A pharmacist, pharmacy intern, or pharmacy technician may not release or discuss
1460 the information contained in a prescription or patient's medication profile to anyone except:
1461 (a) the pharmacy patient in person or the pharmacy patient's legal guardian or designee;
1462 (b) a lawfully authorized federal, state, or local drug enforcement officer;
1463 (c) a third party payment program administered under terms authorized by the
1464 pharmacy patient;
1465 (d) a pharmacist, pharmacy intern, or pharmacy technician providing pharmacy
1466 services to the patient or a prescribing practitioner providing professional services to the
1467 patient;
1468 (e) another pharmacist, pharmacy intern, pharmacy technician, or prescribing
1469 practitioner to whom the patient has requested a prescription transfer; or
1470 (f) the pharmacy patient's attorney, after the presentation of a written authorization
1471 signed by the:
1472 (i) patient, before a notary public;
1473 (ii) parent or lawful guardian, if the patient is a minor;
1474 (iii) lawful guardian, if the patient is incompetent; or
1475 (iv) personal representative, if the patient is deceased.
1476 Section 33. Section 58-17b-605 is enacted to read:
1477 58-17b-605. Drug product equivalents.
1478 (1) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug
1479 by brand or proprietary name may substitute another drug product equivalent if:
1480 (a) the purchaser specifically requests or consents to the substitution of a drug product
1481 equivalent;
1482 (b) the substituted drug product equivalent is of the same generic type and is
1483 designated the therapeutic equivalent in the approved drug products with therapeutic
1484 equivalence evaluations prepared by the Center for Drug Evaluation and Research of the
1485
1486 (c) the substituted drug product is permitted to move in interstate commerce;
1487 (d) the pharmacist or pharmacy intern counsels the patient on the use and the expected
1488 response to the prescribed drug, whether a substitute or not, and the substitution is not
1489 otherwise prohibited by this chapter;
1490 (e) the prescribing practitioner has not indicated that an equivalent drug product is not
1491 to be substituted as provided in Subsection (5); and
1492 (f) the substitution is not otherwise prohibited by law.
1493 (2) (a) Each out-of-state mail service pharmacy dispensing a substituted drug product
1494 into this state shall notify the patient of substitution either by telephone or in writing.
1495 (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
1496 chapter with respect to drugs which may be substituted, including labeling and record keeping,
1497 when dispensing substituted drug products.
1498 (3) Pharmacists or pharmacy interns may not substitute without the prescriber's
1499 authorization on trade name drug product prescriptions unless the product is currently
1500 categorized in the approved drug products with therapeutic equivalence evaluations prepared
1501 by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration
1502 as a drug product considered to be therapeutically equivalent to another drug product.
1503 (4) A pharmacist or pharmacy intern who dispenses a prescription with a drug product
1504 equivalent under this section assumes no greater liability than would be incurred had the
1505 pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
1506 (5) (a) If, in the opinion of the practitioner, it is in the best interest of the patient that an
1507 equivalent drug product not be substituted, the practitioner may indicate a prohibition on
1508 substitution either by writing "dispense as written" or may sign in the appropriate space where
1509 two lines have been preprinted on a prescription order and captioned "dispense as written" or
1510 "substitution permitted".
1511 (b) If the prescription is communicated orally by the practitioner to the pharmacist or
1512 pharmacy intern, the practitioner shall indicate the prohibition on substitution and that
1513 indication shall be noted in writing by the pharmacist or pharmacy intern with the name of the
1514 practitioner and the words "orally by" and the initials of the pharmacy practitioner written after
1515 it.
1516
1517 shall be labeled with the name of the drug dispensed and the pharmacist, pharmacy intern, or
1518 pharmacy technician shall indicate on the file copy of the prescription both the name of the
1519 prescribed drug and the name of the drug dispensed in its place.
1520 (7) Failure of a licensed medical practitioner to specify that no substitution is
1521 authorized does not constitute evidence of negligence.
1522 Section 34. Section 58-17b-606 is enacted to read:
1523 58-17b-606. Restrictive drug formulary prohibited.
1524 (1) As used in this section:
1525 (a) "Generic form" means a prescription drug that is available in generic form and has
1526 an A rating in the United States Pharmacopeia and Drug Index.
1527 (b) "Legend drug" means any drug that requires a prescription under state or federal
1528 law.
1529 (c) "Restrictive drug formulary" means a list of legend drugs, other than drugs for
1530 cosmetic purposes, that are prohibited by the Department of Health from dispensation, but are
1531 approved by the Federal Food and Drug Administration.
1532 (2) A practitioner may prescribe legend drugs in accordance with this chapter that, in
1533 his professional judgment and within the lawful scope of his practice, he considers appropriate
1534 for the diagnosis and treatment of his patient.
1535 (3) Except as provided in Subsection (4), the Department of Health may not maintain a
1536 restrictive drug formulary that restricts a physician's ability to treat a patient with a legend drug
1537 that has been approved and designated as safe and effective by the Federal Food and Drug
1538 Administration, except for drugs for cosmetic purposes.
1539 (4) When a multisource legend drug is available in the generic form, the Department of
1540 Health may only reimburse for the generic form of the drug unless the treating physician
1541 demonstrates to the Department of Health a medical necessity for dispensing the nongeneric,
1542 brand-name legend drug.
1543 (5) This section does not affect the state's ability to exercise the exclusion options
1544 available under the Federal Omnibus Budget Reconciliation Act of 1990.
1545 Section 35. Section 58-17b-607 is enacted to read:
1546 58-17b-607. Drug substitution is not the practice of medicine -- Other causes of
1547
1548 (1) The substitution of any drug by a licensed pharmacist or pharmacy intern under this
1549 chapter does not constitute the practice of medicine.
1550 (2) This chapter may not be construed to deny any individual a cause of action against
1551 a pharmacist, pharmacy intern, or his employer for violations of this chapter, including failure
1552 to observe accepted standards of care of the pharmaceutical profession.
1553 Section 36. Section 58-17b-608 is enacted to read:
1554 58-17b-608. Emergency refills.
1555 (1) In the interest of the patient's health, a pharmacist or pharmacy intern may, in an
1556 emergency, refill a prescription for a patient, but only if the prescribing practitioner is not
1557 available promptly to authorize the refill and only if in the professional judgment of the
1558 pharmacist or pharmacy intern the prescription should be refilled.
1559 (2) Only sufficient medication as necessary in the emergency may be furnished by the
1560 pharmacist or pharmacy intern, not to exceed a three-day supply.
1561 (3) The practitioner shall be contacted as soon as possible for further instructions
1562 concerning the emergency.
1563 Section 37. Section 58-17b-609 is enacted to read:
1564 58-17b-609. Limitation on prescriptions and refills -- Controlled Substances Act
1565 not affected -- Legend drugs.
1566 (1) A prescription for any prescription drug may not be dispensed after one year from
1567 the date it was initiated except as otherwise provided in Chapter 37, Utah Controlled
1568 Substances Act.
1569 (2) A prescription authorized to be refilled may not be refilled after one year from the
1570 original issue date.
1571 (3) A practitioner may not be prohibited from issuing a new prescription for the same
1572 drug orally, in writing, or by electronic transmission.
1573 (4) Nothing in this chapter affects Chapter 37, Utah Controlled Substances Act.
1574 (5) Prescriptions for a legend drug written by a licensed prescribing practitioner in
1575 another state may be filled or refilled by a pharmacist or pharmacy intern in this state, and the
1576 pharmacist or pharmacy intern knows the prescribing practitioner holds a current license.
1577 Section 38. Section 58-17b-610 is enacted to read:
1578
1579 This chapter may not be construed to prevent the personal administration of drugs or
1580 medicines by practitioners licensed to prescribe in order to supply the immediate needs of their
1581 patients. Immediate need for a patient includes giving out drug samples for up to a three-day
1582 supply or the amount necessary to determine the best pharmaceutical agent for that specific
1583 patient.
1584 Section 39. Section 58-17b-611 is enacted to read:
1585 58-17b-611. Pharmacy records.
1586 (1) Each pharmacy shall maintain its prescription files and other records in accordance
1587 with this chapter, division rules made in collaboration with the board, and federal regulations.
1588 (2) Each out-of-state mail service pharmacy shall maintain its prescription files in
1589 accordance with applicable rules or regulations of the state in which its facilities are located
1590 and federal regulations.
1591 Section 40. Section 58-17b-612 is enacted to read:
1592 58-17b-612. Supervision -- Pharmacist-in-charge.
1593 (1) (a) Any pharmacy, except a wholesaler, distributor, or out-of-state mail service
1594 pharmacy, shall be under the general supervision of at least one pharmacist licensed to practice
1595 in Utah. One pharmacist licensed in Utah shall be designated as the pharmacist-in-charge,
1596 whose responsibility it is to oversee the operation of the pharmacy.
1597 (b) Notwithstanding the provisions of Subsection 58-17b-102 (63), a supervising
1598 pharmacist does not have to be in the pharmacy or care facility but shall be available via a
1599 telepharmacy system for immediate contact with the supervised pharmacy technician or
1600 pharmacy intern if:
1601 (i) the pharmacy is located in:
1602 (A) a remote rural hospital, as defined in Section 26-21-13.6 ; or
1603 (B) a clinic located in a remote rural county with less than 20 people per square mile;
1604 (ii) the supervising pharmacist described in Subsection (1)(a), is not available; and
1605 (iii) the telepharmacy system maintains records and files quarterly reports as required
1606 by division rule to assure that patient safety is not compromised.
1607 (2) Each out-of-state mail service pharmacy shall designate and identify to the division
1608 a pharmacist holding a current license in good standing issued by the state in which the
1609
1610 chapter.
1611 Section 41. Section 58-17b-613 is enacted to read:
1612 58-17b-613. Patient counseling.
1613 (1) Every pharmacy facility shall orally offer to counsel a patient or a patient's agent in
1614 a personal face-to-face discussion with respect to each prescription drug dispensed, if the
1615 patient or patient's agent:
1616 (a) delivers the prescription in person to the pharmacist or pharmacy intern; or
1617 (b) receives the drug in person at the time it is dispensed at the pharmacy facility.
1618 (2) A pharmacist or pharmacy intern shall provide counseling to each patient, and shall
1619 provide the patient with a toll-free telephone number by which the patient may contact a
1620 pharmacist at the dispensing pharmacy during normal business hours and receive oral
1621 counseling, with respect to each prescription drug dispensed if the patient provides or the
1622 prescription is otherwise provided to the pharmacy facility by a means other than personal
1623 delivery, and the dispensed prescription drug is mailed or otherwise delivered to the patient
1624 outside of the pharmacy facility.
1624a S (3)(a) THE PROVISIONS OF SUBSECTIONS (1)AND (2) DO NOT APPLY TO INCARCERATED
1624b PATIENTS OR PERSONS OTHERWISE UNDER THE JURISDICTION OF THE UTAH DEPARTMENT OF
1624c CORRECTIONS OR A COUNTY DETENTION FACILITY.
1624d (b)A WRITTEN COMMUNICATION WITH A PERSON DESCRIBED IN SUBSECTION (3)(a) SHALL
1624e BE USED BY A PHARMACIST OR PHARMACY INTERN IN LIEU OF A FACE TO FACE OR TELEPHONIC
1624f COMMUNICATION FOR THE PURPOSE OF COUNSELING THE PATIENT. s
1625 Section 42. Section 58-17b-614 is enacted to read:
1626 58-17b-614. Notification.
1627 (1) A pharmacy shall report in writing to the division not later than ten business days
1628 after the date of:
1629 (a) a permanent closure of the pharmacy facility;
1630 (b) a change of name or ownership;
1631 (c) a change of location of the pharmacy facility;
1632 (d) a sale or transfer of any controlled substance as a result of the permanent closing or
1633 change of ownership of the pharmacy facility;
1634 (e) any matter or occurrence that the board requires by rule to be reported;
1635 (f) a final S ADMINISTRATIVE, DISCIPLINARY s order against the pharmacy license holder
1635a by the regulatory or licensing
1636 agency of the state in which the pharmacy is located if the pharmacy is a class D pharmacy; or
1637 (g) a final order against a pharmacist who is designated as the pharmacist-in-charge of
1638 the pharmacy by the regulatory or licensing agency of the state in which the pharmacy is
1639 located if the pharmacy is a class D pharmacy.
1640
1641 that may effect purity, or labeling of a drug, medication, device, or other material used in the
1642 diagnosis or treatment of injury, illness, or disease immediately on the occurrence of the
1643 disaster, accident, or emergency as defined by rule. The reporting pharmacy shall maintain a
1644 copy of any notification required by this section for two years and make a copy available for
1645 inspection.
1646 Section 43. Section 58-17b-615 is enacted to read:
1647 58-17b-615. Sale of prescription drugs not in normal course of business.
1648 (1) As used in this section, "seller" means a person selling prescription drugs or
1649 devices owned or lawfully controlled by him, or a party arranging for the sale of prescription
1650 drugs or devices owned by or lawfully controlled by another person, including salvage
1651 companies that acquire prescription drugs and devices from, or act as an agent or representative
1652 for freight haulers and forwarders.
1653 (2) Any sale of prescription drugs in bankruptcy, at public auction, at freight
1654 liquidation sales, or any other sale of prescription drugs other than in the normal course of
1655 business or practice shall comply with the following:
1656 (a) a seller of prescription drugs shall be licensed by the division as a prescription drug
1657 distributor or wholesaler with a regular license, or a temporary license for that sale only, before
1658 engaging in the sale of any prescription drugs; and
1659 (b) a person licensed as a pharmacy under this chapter may not acquire by purchase or
1660 other means prescription drugs or devices outside the normal course of business within the
1661 meaning of this section unless:
1662 (i) the prescription drugs or devices are accompanied by a certificate signed by a
1663 licensed pharmacist employed or retained by the seller, as required in Subsection (3), attesting
1664 that the prescription drugs or devices have not been adversely affected by circumstances
1665 relating to their transportation, storage, or distribution; and
1666 (ii) the licensee acquiring the prescription drugs or devices employs a qualified
1667 pharmacist who is responsible for determining that all prescription drugs being acquired do not
1668 pose any threat to the public welfare if introduced into commerce than would be presented by
1669 the acquisition of those prescription drugs and devices in the normal course of business through
1670 established channels of prescription drug distribution.
1671
1672 services of a qualified pharmacist licensed to practice in the state to serve as either an employee
1673 or independent consultant to determine if the:
1674 (a) prescription drugs and devices to be offered for sale have been transported, stored,
1675 and distributed in accordance with applicable federal, state, and local laws; and
1676 (b) condition of the prescription drugs and devices to be offered for sale has been
1677 adversely affected by the circumstances of transportation, storage, or distribution.
1678 (4) The written notice provided to the division prior to the sale of any prescription
1679 drugs or devices under this section shall contain written verification of the pharmacist retained
1680 by the seller, stating the drugs or devices offered for sale have not been adversely affected by
1681 the circumstances of transportation, storage, or distribution.
1682 (5) A pharmacist employed by a seller under Subsection (3) or a pharmacy, distributor,
1683 or wholesaler for whom that pharmacist may be employed or in which he may have an interest,
1684 may not purchase any prescription drugs or devices from the seller for which that pharmacist
1685 has provided verification regarding the drugs or devices.
1686 Section 44. Section 58-17b-616 is enacted to read:
1687 58-17b-616. Drug stock sales -- Labeling.
1688 (1) A manufacturer, wholesaler, or distributor of prescription drugs may not sell or give
1689 any prescription drug to any person unless the prescription drug stock container bears a label
1690 containing information as defined by rule the name and place of business of the manufacturer
1691 of the finished dosage form of the drug, and if different from the manufacturer, the name and
1692 place of business of the packer or distributor.
1693 (2) Each tablet or capsule shall be marked with an identification code or monogram,
1694 unless waived by the division.
1695 (3) Each stock package shall bear an expiration date and lot number.
1696 Section 45. Section 58-17b-617 is enacted to read:
1697 58-17b-617. Limitations on distribution of prescription drugs by pharmaceutical
1698 manufacturers or wholesalers.
1699 (1) A pharmaceutical manufacturer or pharmaceutical wholesaler may not provide a
1700 prescription drug to any person, except as defined by rule.
1701 (2) (a) Prescription drugs that are not controlled substances may be:
1702
1703 prescribe, administer, or conduct research with legend drugs; and
1704 (ii) supplied in connection with a manufacturer's patient assistance program to be
1705 distributed to qualifying patients enrolled in the program.
1706 (b) Controlled substance prescription drugs may be sold or provided only:
1707 (i) upon the issuance of an order or request by a person appropriately licensed under
1708 state and federal law to sell, prescribe, administer, or conduct research with prescription drugs;
1709 and
1710 (ii) upon the establishment of documents in the possession of the manufacturer or
1711 distributor recording the purchaser, type of drug, quantity of drug, date of shipment, and date of
1712 delivery.
1713 (3) Purchasers or those in receipt of drugs under this section shall maintain records in
1714 accordance with federal and state laws regarding controlled substances.
1715 Section 46. Section 58-17b-618 is enacted to read:
1716 58-17b-618. Compliance with federal laws.
1717 The entities licensed under Sections 58-17b-301 and 58-17b-302 shall comply with all
1718 state and federal laws and regulations relating to the practice of pharmacy.
1719 Section 47. Section 58-17b-619 is enacted to read:
1720 58-17b-619. Third party payors -- Health maintenance organizations.
1721 (1) Any third party payor for pharmaceutical services within the state S , OR ITS AGENT OR
1721a CONTRACTOR s may not require
1722 any pharmacy patient to obtain prescription S [
1722a out-of-state H [
1723 pharmacy as a condition of obtaining third party payment S PRESCRIPTION DRUG BENEFIT
1723a COVERAGE s as defined in rule.
1724 (2) S (a) s This section does not prohibit any third party payor of pharmaceutical services,
1724a who
1725 provides for reimbursement to the pharmacy patient or payment on his behalf, from exercising
1726 the right to limit the amount reimbursed for the cost of prescription drugs based upon the cost
1727 of identical prescription drugs available through a designated out-of-state pharmacy.
1727a S (b) NOTWITHSTANDING SUBSECTION (2)(a), ANY THIRD PARTY PAYOR OF
1727b PHARMACEUTICAL SERVICES MAY RESTRICT THE TYPE OF OUTLET WHERE A PATIENT MAY
1727c OBTAIN CERTAIN PRESCRIPTIVE DRUGS AND DEVICES, SUCH AS INJECTABLE MEDICATIONS,
1727d THAT ARE NOT READILY AVAILABLE IN ALL PHARMACIES. THE PAYOR MAY ALSO RESTRICT
1727e ACCESS TO NO MORE THAN ONE MAIL-ORDER PHARMACY. s
1728 (3) Each third party payor of pharmaceutical services shall identify as a part of the third
1729 party agreement or contract the designated out-of-state pharmacy which shall be used as the
1730 base line comparison.
1731 (4) (a) A violation of this section is a class A misdemeanor.
1732 (b) Each violation of this section is a separate offense.
1733
1734 58-17b-620. Prescriptions issued within the public health system.
1735 (1) As used in this section:
1736 (a) "Department of Health" means the state Department of Health created in Section
1737 26-1-4 .
1738 (b) "Health department" means either the Department of Health or a local health
1739 department.
1740 (c) "Local health departments" mean the local health departments created in Title 26A,
1741 Chapter 1, Local Health Departments.
1742 (2) A health department may implement the prescription procedure under Subsection
1743 (3) for prescription drugs, other than controlled substances, for use in clinics providing:
1744 (a) sexually transmitted disease treatment;
1745 (b) fluoride treatment; or
1746 (c) travel immunization.
1747 (3) The following prescription procedure shall be carried out in accordance with the
1748 requirements of Subsection (4) and may be used only in the clinics listed under Subsection (2):
1749 (a) a physician writes and signs a prescription for prescription drugs, other than
1750 controlled substances, without the name and address of the patient and without the date the
1751 prescription is provided to the patient; and
1752 (b) the physician authorizes a registered nurse employed by the health department to
1753 complete the prescription written under this Subsection (3) by inserting the patient's name and
1754 address, and the date the prescription is provided to the patient, in accordance with the
1755 physician's standing written orders and a written health department protocol approved by the
1756 physician and the medical director of the state Department of Health.
1757 (4) When allowing prescriptions to be written under Subsection (3), the health
1758 department shall employ a physician who:
1759 (a) assumes specific responsibility for all prescriptions issued in his name under the
1760 procedure in Subsection (3) by the health department; and
1761 (b) enters into a written, signed agreement with the health department, which
1762 agreement is approved by the division and state:
1763 (i) the terms and conditions under which the physician will prepare and sign
1764
1765 prescription is provided to the patient;
1766 (ii) the methods which will be used to ensure the signed prescriptions are secure and
1767 not available for unauthorized use;
1768 (iii) the minimum qualifications and training of a registered nurse authorized by the
1769 physician and department to complete and provide prescriptions to a patient;
1770 (iv) under what conditions prescriptions completed by an authorized registered nurse
1771 will be provided to a patient in accordance with standing orders and written protocols, and the
1772 specific prescription drugs for which prescriptions may be written;
1773 (v) the manner in which the physician will audit and review the records of patients
1774 receiving prescriptions; and
1775 (vi) the manner in which records of prescriptions issued will be maintained for audit by
1776 the physician and division.
1777 (5) The health department shall file and maintain with the division a current copy of all
1778 agreements signed by physicians under Subsection (4).
1779 (6) (a) All prescription forms to be used by a physician and health department in
1780 accordance with this section shall be serially numbered according to a numbering system
1781 assigned to that health department.
1782 (b) All prescriptions issued shall contain all information required under this chapter
1783 and rules adopted under this chapter.
1784 Section 49. Section 58-17b-621 is enacted to read:
1785 58-17b-621. Automated pharmacy systems.
1786 Automated pharmacy systems can be utilized in licensed pharmacies, remote locations
1787 under the jurisdiction of the Utah State Board of Pharmacy, and licensed health care facilities
1788 where legally permissible, as approved by the division in collaboration with the board, and
1789 described in rule.
1790 Section 50. Section 58-17b-701 is enacted to read:
1791
1792 58-17b-701. Mentally incompetent or incapacitated pharmacist -- Division action
1793 and procedures.
1794 (1) As used in this section:
1795
1796 (b) "Mentally ill" has the same definition as in Section 62A-15-602 .
1797 (2) If a court of competent jurisdiction determines a pharmacist is an incapacitated
1798 person, or that he is mentally ill and unable to safely engage in the practice of pharmacy, the
1799 director shall immediately suspend the license of the pharmacist upon the entry of the judgment
1800 of the court, without further proceedings under Title 63, Chapter 46b, Administrative
1801 Procedures Act, regardless of whether an appeal from the court's ruling is pending. The
1802 director shall promptly notify the pharmacist, in writing, of the suspension.
1803 (3) (a) If the division and a majority of the board find reasonable cause to believe a
1804 pharmacist, who is not determined judicially to be an incapacitated person or to be mentally ill,
1805 is incapable of practicing pharmacy with reasonable skill regarding the safety of patients,
1806 because of illness, excessive use of drugs or alcohol, or as a result of any mental or physical
1807 condition, the board shall recommend that the director file a petition with the division, and
1808 cause the petition to be served upon the pharmacist with a notice of hearing on the sole issue of
1809 the capacity of the pharmacist to competently and safely engage in the practice of pharmacy.
1810 (b) The hearing shall be conducted under Section 58-1-109 and Title 63, Chapter 46b,
1811 Administrative Procedures Act, except as provided in Subsection (4).
1812 (4) (a) Every pharmacist who accepts the privilege of being licensed under this chapter
1813 gives consent to:
1814 (i) submitting at his own expense to an immediate mental or physical examination
1815 when directed in writing by the division, with the consent of a majority of the board, to do so;
1816 and
1817 (ii) the admissibility of the reports of the examining practitioner's testimony or
1818 examination in any proceeding regarding the license of the pharmacist, and waives all
1819 objections on the ground the reports constitute a privileged communication.
1820 (b) The examination may be ordered by the division, with the consent of a majority of
1821 the board, only upon a finding of reasonable cause to believe:
1822 (i) the pharmacist is mentally ill or incapacitated or otherwise unable to practice
1823 pharmacy with reasonable skill and safety; and
1824 (ii) immediate action by the division and the board is necessary to prevent harm to the
1825 pharmacist's patients or the general public.
1826
1827 is a ground for the division's immediate suspension of the pharmacist's license by written order
1828 of the director.
1829 (ii) The division may enter the order of suspension without further compliance with
1830 Title 63, Chapter 46b, Administrative Procedures Act, unless the division finds the failure to
1831 submit to the examination ordered under this section was due to circumstances beyond the
1832 control of the pharmacist and was not related directly to the illness or incapacity of the
1833 pharmacist.
1834 (5) (a) A pharmacist whose license is suspended under Subsection (2) or (4) has the
1835 right to a hearing to appeal the suspension within ten days after the license is suspended.
1836 (b) The hearing held under this Subsection (5) shall be conducted in accordance with
1837 Sections 58-1-108 and 58-1-109 for the sole purpose of determining if sufficient basis exists
1838 for the continuance of the order of suspension in order to prevent harm to the pharmacist's
1839 patients or the general public.
1840 (6) A pharmacist whose license is revoked, suspended, or in any way restricted under
1841 this section may request the division and the board to consider, at reasonable intervals,
1842 evidence presented by the pharmacist, under procedures established by division rule, regarding
1843 any change in the pharmacist's condition, to determine whether:
1844 (a) he is or is not able to safely and competently engage in the practice of pharmacy;
1845 and
1846 (b) he is qualified to have his licensure to practice under this chapter restored
1847 completely or in part.
1848 Section 51. Section 58-24a-105 is amended to read:
1849 58-24a-105. Administration of agents -- Limitation.
1850 (1) Physical therapists may administer the following agents under the provisions of
1851 Subsection (2):
1852 (a) topically applied medicinal agents, including steroids and analgesics for wound care
1853 and for musculoskeletal treatment using iontophoresis or phonorphoresis; and
1854 (b) pharmaceutical aerosols for pulmonary hygiene in an institutional setting in which
1855 the services of a licensed respiratory therapist are not available in the institution or within a
1856 ten-mile radius of the institution.
1857
1858 prescription drug as defined in Section [
1859 prescription of a practitioner licensed to prescribe that drug.
1860 (3) This section does not authorize a physical therapist to possess for dispensing or
1861 dispense a prescription drug.
1862 Section 52. Section 58-37-6 is amended to read:
1863 58-37-6. License to manufacture, produce, distribute, dispense, administer, or
1864 conduct research -- Issuance by department -- Denial, suspension, or revocation --
1865 Records required -- Prescriptions.
1866 (1) (a) The department may adopt rules relating to the licensing and control of the
1867 manufacture, distribution, production, prescription, administration, dispensing, conducting of
1868 research with, and performing of laboratory analysis upon controlled substances within this
1869 state.
1870 (b) The department may assess reasonable fees to defray the cost of issuing original
1871 and renewal licenses under this chapter pursuant to Section 63-38-3.2 .
1872 (c) The director of the department may delegate to any division or agency within the
1873 department, authority to perform the responsibilities and functions prescribed to the department
1874 under this chapter if the delegated authority is consistent with the function of the division or
1875 agency provided by law.
1876 (2) (a) (i) Every person who manufactures, produces, distributes, prescribes, dispenses,
1877 administers, conducts research with, or performs laboratory analysis upon any controlled
1878 substance in Schedules II through V within this state, or who proposes to engage in
1879 manufacturing, producing, distributing, prescribing, dispensing, administering, conducting
1880 research with, or performing laboratory analysis upon controlled substances included in
1881 Schedules II through V within this state shall obtain a license issued by the department.
1882 (ii) The division shall issue each license under this chapter in accordance with a
1883 two-year renewal cycle established by rule. The division may by rule extend or shorten a
1884 renewal period by as much as one year to stagger the renewal cycles it administers.
1885 (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
1886 administer, conduct research with, or perform laboratory analysis upon controlled substances in
1887 Schedules II through V within this state may possess, manufacture, produce, distribute,
1888
1889 those substances to the extent authorized by their license and in conformity with this chapter.
1890 (c) The following persons are not required to obtain a license and may lawfully possess
1891 controlled substances under this section:
1892 (i) an agent or employee, except a sales representative, of any registered manufacturer,
1893 distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
1894 usual course of his business or employment; however, nothing in this Subsection (2) shall be
1895 interpreted to permit an agent, employee, sales representative, or detail man to maintain an
1896 inventory of controlled substances separate from the location of his employer's registered and
1897 licensed place of business;
1898 (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
1899 warehouseman, who possesses any controlled substance in the usual course of his business or
1900 employment; and
1901 (iii) an ultimate user, or any person who possesses any controlled substance pursuant to
1902 a lawful order of a practitioner.
1903 (d) The department may enact rules waiving the license requirement for certain
1904 manufacturers, producers, distributors, prescribers, dispensers, administrators, research
1905 practitioners, or laboratories performing analysis if consistent with the public health and safety.
1906 (e) A separate license is required at each principal place of business or professional
1907 practice where the applicant manufactures, produces, distributes, prescribes, dispenses,
1908 administers, conducts research with, or performs laboratory analysis upon controlled
1909 substances.
1910 (f) The department may enact rules providing for the inspection of a licensee or
1911 applicant's establishment, and may inspect the establishment according to those rules.
1912 (3) (a) Upon proper application, the department shall license a qualified applicant to
1913 manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
1914 controlled substances included in Schedules I through V, unless it determines that issuance of a
1915 license is inconsistent with the public interest. The department shall not issue a license to any
1916 person to prescribe, dispense, or administer a Schedule I controlled substance. In determining
1917 public interest, the department shall consider whether or not the applicant has:
1918 (i) maintained effective controls against diversion of controlled substances and any
1919
1920 legitimate medical, scientific, or industrial channels;
1921 (ii) complied with applicable state and local law;
1922 (iii) been convicted under federal or state laws relating to the manufacture, distribution,
1923 or dispensing of substances;
1924 (iv) past experience in the manufacture of controlled dangerous substances;
1925 (v) established effective controls against diversion; and
1926 (vi) complied with any other factors that the department establishes that promote the
1927 public health and safety.
1928 (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
1929 produce, distribute, conduct research with, or perform laboratory analysis upon controlled
1930 substances in Schedule I other than those specified in the license.
1931 (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
1932 substances in Schedules II through V if they are authorized to administer, dispense, or conduct
1933 research under the laws of this state.
1934 (ii) The department need not require a separate license for practitioners engaging in
1935 research with nonnarcotic controlled substances in Schedules II through V where the licensee is
1936 already licensed under this act in another capacity.
1937 (iii) With respect to research involving narcotic substances in Schedules II through V,
1938 or where the department by rule requires a separate license for research of nonnarcotic
1939 substances in Schedules II through V, a practitioner shall apply to the department prior to
1940 conducting research.
1941 (iv) Licensing for purposes of bona fide research with controlled substances by a
1942 practitioner considered qualified may be denied only on a ground specified in Subsection (4),
1943 or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
1944 adequately his supply of substances against diversion from medical or scientific use.
1945 (v) Practitioners registered under federal law to conduct research in Schedule I
1946 substances may conduct research in Schedule I substances within this state upon furnishing the
1947 department evidence of federal registration.
1948 (d) Compliance by manufacturers, producers, and distributors with the provisions of
1949 federal law respecting registration, excluding fees, entitles them to be licensed under this
1950
1951 (e) The department shall initially license those persons who own or operate an
1952 establishment engaged in the manufacture, production, distribution, dispensation, or
1953 administration of controlled substances prior to April 3, 1980, and who are licensed by the
1954 state.
1955 (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed
1956 on probation, or revoked by the department upon finding that the applicant or licensee has:
1957 (i) materially falsified any application filed or required pursuant to this chapter;
1958 (ii) been convicted of an offense under this chapter or any law of the United States, or
1959 any state, relating to any substance defined as a controlled substance;
1960 (iii) been convicted of a felony under any other law of the United States or any state
1961 within five years of the date of the issuance of the license;
1962 (iv) had a federal license denied, suspended, or revoked by competent federal authority
1963 and is no longer authorized to engage in the manufacturing, distribution, or dispensing of
1964 controlled substances;
1965 (v) had his license suspended or revoked by competent authority of another state for
1966 violation of laws or regulations comparable to those of this state relating to the manufacture,
1967 distribution, or dispensing of controlled substances;
1968 (vi) violated any department rule that reflects adversely on the licensee's reliability and
1969 integrity with respect to controlled substances;
1970 (vii) refused inspection of records required to be maintained under this chapter by a
1971 person authorized to inspect them; or
1972 (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
1973 purpose of manipulating human hormonal structure so as to:
1974 (A) increase muscle mass, strength, or weight without medical necessity and without a
1975 written prescription by any practitioner in the course of his professional practice; or
1976 (B) improve performance in any form of human exercise, sport, or game.
1977 (b) The department may limit revocation or suspension of a license to a particular
1978 controlled substance with respect to which grounds for revocation or suspension exist.
1979 (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant to
1980 this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division of
1981
1982 appropriate representative committee designated by the director of the department.
1983 (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
1984 Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
1985 except where the department is designated by law to perform those functions, or, when not
1986 designated by law, is designated by the executive director of the Department of Commerce to
1987 conduct the proceedings.
1988 (d) (i) The department may suspend any license simultaneously with the institution of
1989 proceedings under this section if it finds there is an imminent danger to the public health or
1990 safety.
1991 (ii) Suspension shall continue in effect until the conclusion of proceedings, including
1992 judicial review, unless withdrawn by the department or dissolved by a court of competent
1993 jurisdiction.
1994 (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
1995 substances owned or possessed by the licensee may be placed under seal in the discretion of the
1996 department.
1997 (ii) Disposition may not be made of substances under seal until the time for taking an
1998 appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
1999 orders the sale of perishable substances and the proceeds deposited with the court.
2000 (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
2001 (f) The department shall notify promptly the Drug Enforcement Administration of all
2002 orders suspending or revoking a license and all forfeitures of controlled substances.
2003 (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and
2004 inventories in conformance with the record keeping and inventory requirements of federal and
2005 state law and any additional rules issued by the department.
2006 (b) (i) Every physician, dentist, veterinarian, practitioner, or other person who is
2007 authorized to administer or professionally use a controlled substance shall keep a record of the
2008 drugs received by him and a record of all drugs administered, dispensed, or professionally used
2009 by him otherwise than by a prescription.
2010 (ii) A person using small quantities or solutions or other preparations of those drugs for
2011 local application has complied with this Subsection (5)(b) if he keeps a record of the quantity,
2012
2013 the dates when purchased or prepared.
2014 (6) Controlled substances in Schedules I through V may be distributed only by a
2015 licensee and pursuant to an order form prepared in compliance with department rules or a
2016 lawful order under the rules and regulations of the United States.
2017 (7) (a) A person may not write or authorize a prescription for a controlled substance
2018 unless he is:
2019 (i) a practitioner authorized to prescribe drugs and medicine under the laws of this state
2020 or under the laws of another state having similar standards; and
2021 (ii) licensed under this chapter or under the laws of another state having similar
2022 standards.
2023 (b) A person other than a pharmacist licensed under the laws of this state, or his
2024 licensed intern, as required by [
2025 not dispense a controlled substance.
2026 (c) (i) A controlled substance may not be dispensed without the written prescription of
2027 a practitioner, if the written prescription is required by the federal Controlled Substances Act.
2028 (ii) That written prescription shall be made in accordance with Subsection (7)(a) and in
2029 conformity with Subsection (7)(d).
2030 (iii) In emergency situations, as defined by department rule, controlled substances may
2031 be dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
2032 designated by the department and filed by the pharmacy.
2033 (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
2034 Subsection (7)(d).
2035 (d) Except for emergency situations designated by the department, a person may not
2036 issue, fill, compound, or dispense a prescription for a controlled substance unless the
2037 prescription is signed in ink or indelible pencil by the prescriber and contains the following
2038 information:
2039 (i) the name, address, and registry number of the prescriber;
2040 (ii) the name, address, and age of the person to whom or for whom the prescription is
2041 issued;
2042 (iii) the date of issuance of the prescription; and
2043
2044 controlled substance.
2045 (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
2046 controlled substance.
2047 (f) Except when administered directly to an ultimate user by a licensed practitioner,
2048 controlled substances are subject to the following restrictions:
2049 (i) (A) A prescription for a Schedule II substance may not be refilled.
2050 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
2051 one-month's supply, as directed on the daily dosage rate of the prescriptions.
2052 (ii) A Schedule III or IV controlled substance may be filled only within six months of
2053 issuance, and may not be refilled more than six months after the date of its original issuance or
2054 be refilled more than five times after the date of the prescription unless renewed by the
2055 practitioner.
2056 (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
2057 prescription directs, but they may not be refilled one year after the date the prescription was
2058 issued unless renewed by the practitioner.
2059 (iv) Any prescription for a Schedule II substance may not be dispensed if it is not
2060 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
2061 after the date the prescription was issued, or 30 days after the dispensing date, if that date is
2062 specified separately from the date of issue.
2063 (v) A practitioner may issue more than one prescription at the same time for the same
2064 Schedule II controlled substance, but only under the following conditions:
2065 (A) no more than three prescriptions for the same Schedule II controlled substance may
2066 be issued at the same time;
2067 (B) no one prescription may exceed a 30-day supply;
2068 (C) a second or third prescription shall include the date of issuance and the date for
2069 dispensing; and
2070 (D) unless the practitioner determines there is a valid medical reason to the contrary,
2071 the date for dispensing a second or third prescription may not be fewer than 30 days from the
2072 dispensing date of the previous prescription.
2073 (vi) Each prescription for a controlled substance may contain only one controlled
2074
2075 item.
2076 (g) An order for a controlled substance in Schedules II through V for use by an
2077 inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
2078 Subsection (7) if the order is:
2079 (i) issued or made by a prescribing practitioner who holds an unrestricted registration
2080 with the federal Drug Enforcement Administration, and an active Utah controlled substance
2081 license in good standing issued by the division under this section, or a medical resident who is
2082 exempted from licensure under Subsection 58-1-307 (1)(c);
2083 (ii) authorized by the prescribing practitioner treating the patient and the prescribing
2084 practitioner designates the quantity ordered;
2085 (iii) entered upon the record of the patient, the record is signed by the prescriber
2086 affirming his authorization of the order within 48 hours after filling or administering the order,
2087 and the patient's record reflects the quantity actually administered; and
2088 (iv) filled and dispensed by a pharmacist practicing his profession within the physical
2089 structure of the hospital, or the order is taken from a supply lawfully maintained by the hospital
2090 and the amount taken from the supply is administered directly to the patient authorized to
2091 receive it.
2092 (h) A practitioner licensed under this chapter may not prescribe, administer, or
2093 dispense a controlled substance to a minor, without first obtaining the consent required in
2094 Section 78-14-5 of a parent, guardian, or person standing in loco parentis of the minor except
2095 in cases of an emergency. For purposes of this Subsection (7)(h), "minor" has the same
2096 meaning as defined in Section 78-3a-103 , and "emergency" means any physical condition
2097 requiring the administration of a controlled substance for immediate relief of pain or suffering.
2098 (i) A practitioner licensed under this chapter may not prescribe or administer dosages
2099 of a controlled substance in excess of medically recognized quantities necessary to treat the
2100 ailment, malady, or condition of the ultimate user.
2101 (j) A practitioner licensed under this chapter may not prescribe, administer, or dispense
2102 any controlled substance to another person knowing that the other person is using a false name,
2103 address, or other personal information for the purpose of securing the controlled substance.
2104 (k) A person who is licensed under this chapter to manufacture, distribute, or dispense
2105
2106 another licensee or any other authorized person not authorized by this license.
2107 (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a
2108 symbol required by this chapter or by a rule issued under this chapter.
2109 (m) A person licensed under this chapter may not refuse or fail to make, keep, or
2110 furnish any record notification, order form, statement, invoice, or information required under
2111 this chapter.
2112 (n) A person licensed under this chapter may not refuse entry into any premises for
2113 inspection as authorized by this chapter.
2114 (o) A person licensed under this chapter may not furnish false or fraudulent material
2115 information in any application, report, or other document required to be kept by this chapter or
2116 willfully make any false statement in any prescription, order, report, or record required by this
2117 chapter.
2118 (8) (a) (i) Any person licensed under this chapter who is found by the department to
2119 have violated any of the provisions of Subsections (7)(k) through (7)(o) is subject to a penalty
2120 not to exceed $5,000. The department shall determine the procedure for adjudication of any
2121 violations in accordance with Sections 58-1-106 and 58-1-108 .
2122 (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in the
2123 General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
2124 (b) Any person who knowingly and intentionally violates Subsections (7)(h) through
2125 (7)(j) is:
2126 (i) upon first conviction, guilty of a class B misdemeanor;
2127 (ii) upon second conviction, guilty of a class A misdemeanor; and
2128 (iii) on third or subsequent conviction, guilty of a third degree felony.
2129 (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
2130 (7)(o) shall upon conviction be guilty of a third degree felony.
2131 (9) Any information communicated to any licensed practitioner in an attempt to
2132 unlawfully procure, or to procure the administration of, a controlled substance is not considered
2133 to be a privileged communication.
2134 Section 53. Section 58-37-7.5 is amended to read:
2135 58-37-7.5. Controlled substance database -- Advisory committee -- Pharmacy
2136
2137 (1) As used in this section:
2138 (a) "Committee" means the Controlled Substance Database Advisory Committee
2139 created in this section.
2140 (b) "Database" means the controlled substance database created in this section.
2141 (c) "Database manager" means the person responsible for operating the database, or his
2142 designee.
2143 (d) "Division" means the Division of Occupational and Professional Licensing created
2144 in Section 58-1-103 .
2145 [
2146 [
2147 (f) "Pharmacy or pharmaceutical facility" has the same definition as in Section
2148 58-17b-102 .
2149 (2) (a) There is created within the division a controlled substance database.
2150 (b) The division shall administer and direct the functioning of the database in
2151 accordance with this section. The division may under state procurement laws contract with
2152 another state agency or private entity to establish, operate, or maintain the database. The
2153 division in collaboration with the board shall determine whether to operate the database within
2154 the division or contract with another entity to operate the database, based on an analysis of
2155 costs and benefits.
2156 (c) The purpose of the database is to contain data as described in this section regarding
2157 every prescription for a controlled substance dispensed in the state to any person other than an
2158 inpatient in a licensed health care facility.
2159 (d) Data required by this section shall be submitted in compliance with this section to
2160 the manager of the database by the pharmacist in charge of the drug outlet where the controlled
2161 substance is dispensed.
2162 (3) (a) There is created the Controlled Substance Database Advisory Committee. The
2163 committee members are:
2164 (i) two members representing the Utah Medical Association;
2165 (ii) one member representing the Utah Dental Association;
2166 (iii) two members representing the Utah Pharmaceutical Association;
2167
2168 (v) one member representing the Utah Association of Chiefs of Police;
2169 (vi) one member representing the Utah Sheriffs Association;
2170 (vii) one member representing the state Office of the Attorney General;
2171 (viii) one member representing the Statewide Association of Public Attorneys; and
2172 (ix) three members representing the general public, and who are not health care
2173 providers.
2174 (b) The committee shall be appointed and serve in accordance with Section 58-1-201 .
2175 (c) The committee shall advise the division regarding:
2176 (i) establishing, maintaining, and operating the database;
2177 (ii) access to the database and how access is obtained; and
2178 (iii) control of information contained in the database.
2179 (4) The pharmacist in charge shall, regarding each controlled substance dispensed by a
2180 pharmacist under his supervision other than those dispensed for an inpatient at a health care
2181 facility, submit to the manager of the database the following information, by a procedure and in
2182 a format established by the division:
2183 (a) name of the prescribing practitioner;
2184 (b) date of the prescription;
2185 (c) date the prescription was filled;
2186 (d) name of the person for whom the prescription was written;
2187 (e) positive identification of the person receiving the prescription, including the type of
2188 identification and any identifying numbers on the identification;
2189 (f) name of the controlled substance;
2190 (g) quantity of controlled substance prescribed;
2191 (h) strength of controlled substance;
2192 (i) quantity of controlled substance dispensed;
2193 (j) dosage quantity and frequency as prescribed;
2194 (k) name of drug outlet dispensing the controlled substance;
2195 (l) name of pharmacist dispensing the controlled substance; and
2196 (m) other relevant information as required by division rule.
2197 (5) The division shall maintain the database in an electronic file or by other means
2198
2199 (a) prescribing practices and patterns of prescribing and dispensing controlled
2200 substances;
2201 (b) practitioners prescribing controlled substances in an unprofessional or unlawful
2202 manner;
2203 (c) individuals receiving prescriptions for controlled substances from licensed
2204 practitioners, and who subsequently obtain dispensed controlled substances from a drug outlet
2205 in quantities or with a frequency inconsistent with generally recognized standards of dosage for
2206 that controlled substance; and
2207 (d) individuals presenting forged or otherwise false or altered prescriptions for
2208 controlled substances to a [
2209 (6) (a) The division shall by rule establish the electronic format in which the
2210 information required under this section shall be submitted to the administrator of the database.
2211 (b) The division shall ensure the database system records and maintains for reference:
2212 (i) identification of each person who requests or receives information from the
2213 database;
2214 (ii) the information provided to each person; and
2215 (iii) the date and time the information is requested or provided.
2216 (7) The division shall make rules in collaboration with the committee to:
2217 (a) effectively enforce the limitations on access to the database as described in
2218 Subsection (8); and
2219 (b) establish standards and procedures to ensure accurate identification of individuals
2220 requesting information or receiving information without request from the database.
2221 (8) The manager of the database shall make information in the database available only
2222 to the following persons, and in accordance with the limitations stated and division rules:
2223 (a) personnel of the division specifically assigned to conduct investigations related to
2224 controlled substances laws under the jurisdiction of the division;
2225 (b) authorized division personnel engaged in analysis of controlled substance
2226 prescription information as a part of the assigned duties and responsibilities of their
2227 employment;
2228 (c) a licensed practitioner having authority to prescribe controlled substances, to the
2229
2230 practitioner is prescribing or considering prescribing any controlled substance;
2231 (d) a licensed pharmacist having authority to dispense controlled substances to the
2232 extent the information relates specifically to a current patient to whom that pharmacist is
2233 dispensing or considering dispensing any controlled substance;
2234 (e) federal, state, and local law enforcement authorities engaged as a specified duty of
2235 their employment in enforcing laws regulating controlled substances; and
2236 (f) an individual who is the recipient of a controlled substance prescription entered into
2237 the database, upon providing evidence satisfactory to the database manager that the individual
2238 requesting the information is in fact the person about whom the data entry was made.
2239 (9) Any person who knowingly and intentionally releases any information in the
2240 database in violation of the limitations under Subsection (8) is guilty of a third degree felony.
2241 (10) Any person who obtains or attempts to obtain information from the database by
2242 misrepresentation or fraud is guilty of a third degree felony.
2243 (11) (a) A person may not knowingly and intentionally use, release, publish, or
2244 otherwise make available to any other person or entity any information obtained from the
2245 database for any purpose other than those specified in Subsection (8). Each separate violation
2246 of this Subsection (11) is a third degree felony and is also subject to a civil penalty not to
2247 exceed $5,000.
2248 (b) The procedure for determining a civil violation of this Subsection (11) shall be in
2249 accordance with Section 58-1-108 , regarding adjudicative proceedings within the division.
2250 (c) Civil penalties assessed under this Subsection (11) shall be deposited in the General
2251 Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
2252 (12) (a) The failure of a pharmacist in charge to submit information to the database as
2253 required under this section after the division has submitted a specific written request for the
2254 information or when the division determines the individual has a demonstrable pattern of
2255 failing to submit the information as required is grounds for the division to take the following
2256 actions in accordance with Section 58-1-401 :
2257 (i) refuse to issue a license to the individual;
2258 (ii) refuse to renew the individual's license;
2259 (iii) revoke, suspend, restrict, or place on probation the license;
2260
2261 (v) issue a cease and desist order; and
2262 (vi) impose a civil penalty of not more than $1,000 for each dispensed prescription
2263 regarding which the required information is not submitted.
2264 (b) Civil penalties assessed under Subsection (12)(a)(vi) shall be deposited in the
2265 General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
2266 (c) The procedure for determining a civil violation of this Subsection (12) shall be in
2267 accordance with Section 58-1-108 , regarding adjudicative proceedings within the division.
2268 (13) An individual who has submitted information to the database in accordance with
2269 this section may not be held civilly liable for having submitted the information.
2270 (14) All department and the division costs necessary to establish and operate the
2271 database shall be funded by appropriations from:
2272 (a) the Commerce Service Fund; and
2273 (b) the General Fund.
2274 (15) All costs associated with recording and submitting data as required in this section
2275 shall be assumed by the submitting [
2276 Section 54. Section 58-37c-19.5 is amended to read:
2277 58-37c-19.5. Iodine solution greater than 1.5% -- Prescription or permit required
2278 -- Penalties.
2279 (1) As used in this section, "iodine matrix" means iodine at concentrations greater than
2280 1.5% by weight in a matrix or solution.
2281 (2) A person may offer to sell, sell, or distribute an iodine matrix only:
2282 (a) as a prescription drug, pursuant to a prescription issued by a veterinarian or
2283 physician licensed within the state; or
2284 (b) to a person who is actively engaged in the legal practice of animal husbandry of
2285 livestock, as defined in Section 4-1-8 .
2286 (3) Prescriptions issued under this section:
2287 (a) shall provide for a specified number of refills;
2288 (b) may be issued by electronic means, in accordance with Title 58, Chapter [
2289 Pharmacy Practice Act; and
2290 (c) may be filled by a person other than the veterinarian or physician issuing the
2291
2292 (4) A retailer offering iodine matrix for sale:
2293 (a) shall store the iodine matrix so that the public does not have access to the iodine
2294 matrix without the direct assistance or intervention of a retail employee;
2295 (b) shall keep a record, which may consist of sales receipts, of each person purchasing
2296 iodine matrix; and
2297 (c) may, if necessary to ascertain the identity of the purchaser, ask for proof of
2298 identification from the purchaser.
2299 (5) A person engaging in a regulated transaction under Subsection (2) is guilty of a
2300 class B misdemeanor if the person, under circumstances not amounting to a violation of
2301 Subsection 58-37d-4 (1)(c), offers to sell, sells, or distributes an iodine matrix to a person who:
2302 (a) does not present a prescription or is not engaged in animal husbandry, as required
2303 under Subsection (2); or
2304 (b) is not excepted under Subsection (7).
2305 (6) A person is guilty of a class A misdemeanor who, under circumstances not
2306 amounting to a violation of Subsection 58-37c-3 (12)(k) or 58-37d-4 (1)(a):
2307 (a) possesses an iodine matrix without proof of obtaining the solution in compliance
2308 with Subsection (2); or
2309 (b) offers to sell, sells, or distributes an iodine matrix in violation of Subsection (2).
2310 (7) Subsection (6)(a) does not apply to:
2311 (a) a chemistry or chemistry-related laboratory maintained by:
2312 (i) a public or private regularly established secondary school; or
2313 (ii) a public or private institution of higher education that is accredited by a regional or
2314 national accrediting agency recognized by the United States Department of Education;
2315 (b) a veterinarian licensed to practice under Title 58, Chapter 28, Veterinary Practice
2316 Act;
2317 (c) a general acute hospital; or
2318 (d) a veterinarian, physician, pharmacist, retail distributor, wholesaler, manufacturer,
2319 warehouseman, or common carrier, or an agent of any of these persons who possesses an
2320 iodine matrix in the regular course of lawful business activities.
2321 Section 55. Section 58-71-102 is amended to read:
2322
2323 In addition to the definitions in Section 58-1-102 , as used in this chapter:
2324 (1) "Administrative penalty" means a monetary fine imposed by the division for acts or
2325 omissions determined to constitute unprofessional or unlawful conduct, as a result of an
2326 adjudicative proceeding conducted in accordance with Title 63, Chapter 46b, Administrative
2327 Procedures Act.
2328 (2) "Acupuncture" has the same definition as in Section 58-72-102 .
2329 (3) "Board" means the Naturopathic Physicians Licensing Board created in Section
2330 58-71-201 .
2331 (4) "Diagnose" means:
2332 (a) to examine in any manner another person, parts of a person's body, substances,
2333 fluids, or materials excreted, taken, or removed from a person's body, or produced by a person's
2334 body, to determine the source, nature, kind, or extent of a disease or other physical or mental
2335 condition;
2336 (b) to attempt to conduct an examination or determination described under Subsection
2337 (4)(a); [
2338 (c) to hold oneself out as making or to represent that one is making an examination or
2339 determination as described in Subsection (4)(a); or
2340 (d) to make an examination or determination as described in Subsection (4)(a) upon or
2341 from information supplied directly or indirectly by another person, whether or not in the
2342 presence of the person making or attempting the diagnosis or examination.
2343 (5) "Local anesthesia" means an agent, whether a natural medicine or prescription drug,
2344 which:
2345 (a) is applied topically or by injection in superficial tissues associated with the
2346 performance of minor office procedures;
2347 (b) has the ability to produce loss of sensation at the site of minor office procedures;
2348 and
2349 (c) does not cause loss of consciousness or produce general sedation.
2350 (6) "Medical naturopathic assistant" means an unlicensed individual working under the
2351 direct and immediate supervision of a licensed naturopathic physician and engaged in specific
2352 tasks assigned by the licensed naturopathic physician in accordance with the standards and
2353
2354 (7) (a) "Minor office procedures" means:
2355 (i) the use of operative, electrical, or other methods for repair and care of superficial
2356 lacerations, abrasions, and benign lesions;
2357 (ii) removal of foreign bodies located in the superficial tissues, excluding the eye or
2358 ear; and
2359 (iii) the use of antiseptics and local anesthetics in connection with minor office surgical
2360 procedures; and
2361 (b) "Minor office procedures" does not include:
2362 (i) general or spinal anesthesia;
2363 (ii) office procedures more complicated or extensive than those set forth in Subsection
2364 (7)(a);
2365 (iii) procedures involving the eye; or
2366 (iv) any office procedure involving tendons, nerves, veins, or arteries.
2367 (8) "Natural medicine" means:
2368 (a) food, food extracts, dietary supplements as defined by the federal Food, Drug, and
2369 Cosmetics Act, all homeopathic remedies, and plant substances that are not designated as
2370 prescription drugs or controlled substances;
2371 (b) over-the-counter medications;
2372 (c) other nonprescription substances, the prescription or administration of which is not
2373 otherwise prohibited or restricted under federal or state law; and
2374 (d) prescription drugs:
2375 (i) that are not controlled substances as defined in Section 58-37-2 ;
2376 (ii) the prescription of which is consistent with the competent practice of naturopathic
2377 medicine; and
2378 (iii) the prescription of which is approved by the division in collaboration with the
2379 naturopathic formulary advisory peer committee.
2380 (9) (a) "Naturopathic childbirth" means uncomplicated natural childbirth assisted by a
2381 naturopathic physician, and includes the use of:
2382 (i) natural medicines; and
2383 (ii) uncomplicated episiotomy.
2384
2385 (i) forceps delivery;
2386 (ii) general or spinal anesthesia;
2387 (iii) caesarean section delivery; or
2388 (iv) induced labor or abortion.
2389 (10) "Naturopathic mobilization therapy":
2390 (a) means manually administering mechanical treatment of body structures or tissues
2391 for the purpose of restoring normal physiological function to the body by normalizing and
2392 balancing the musculoskeletal system of the body;
2393 (b) does not mean manipulation or adjustment of the joints of the human body beyond
2394 the elastic barrier; and
2395 (c) does not include manipulation as defined in Title 58, Chapter 73, Chiropractic
2396 Physician Practice Act.
2397 (11) "Naturopathic physical medicine" means the use of the physical agents of air,
2398 water, heat, cold, sound, light, and electromagnetic nonionizing radiation, and the physical
2399 modalities of electrotherapy, biofeedback, acupuncture, diathermy, ultraviolet light, ultrasound,
2400 hydrotherapy, naturopathic mobilization therapy, and exercise. Naturopathic medicine does not
2401 include the practice of physical therapy or physical rehabilitation.
2402 (12) "Practice of naturopathic medicine" means:
2403 (a) a system of primary health care for the prevention, diagnosis, and treatment of
2404 human health conditions, injuries, and diseases that uses education, natural medicines, and
2405 natural therapies, to support and stimulate the patient's intrinsic self-healing processes:
2406 (i) using naturopathic childbirth, but only if:
2407 (A) the licensee meets standards of the American College of Naturopathic
2408 Obstetricians (ACNO) or its successor as determined by the division in collaboration with the
2409 board; and
2410 (B) the licensee follows a written plan for naturopathic physicians practicing
2411 naturopathic childbirth approved by the division in collaboration with the board, which
2412 includes entering into an agreement with a consulting physician and surgeon or osteopathic
2413 physician, in cases where the scope of practice of naturopathic childbirth may be exceeded and
2414 specialty care and delivery is indicated, detailing the guidelines by which the naturopathic
2415
2416 (I) refer patients to the consulting physician; and
2417 (II) consult with the consulting physician;
2418 (ii) using naturopathic mobilization therapy;
2419 (iii) using naturopathic physical medicine;
2420 (iv) using minor office procedures;
2421 (v) prescribing or administering natural medicine;
2422 (vi) prescribing medical equipment and devices, diagnosing by the use of medical
2423 equipment and devices, and administering therapy or treatment by the use of medical devices
2424 necessary and consistent with the competent practice of naturopathic medicine;
2425 (vii) prescribing barrier devices for contraception;
2426 (viii) using dietary therapy;
2427 (ix) taking and using diagnostic x-rays, electrocardiograms, ultrasound, and
2428 physiological function tests;
2429 (x) taking of body fluids for clinical laboratory tests and using the results of the tests in
2430 diagnosis;
2431 (xi) taking of a history from and conducting of a physical examination upon a human
2432 patient; and
2433 (xii) prescribing and administering natural medicines and medical devices, except a
2434 naturopathic physician may only administer:
2435 (A) a prescription drug, as defined in Section [
2436 with Subsection (8)(d); and
2437 (B) local anesthesia that is not a controlled substance, and only in the performance of
2438 minor office procedures;
2439 (b) to maintain an office or place of business for the purpose of doing any of the acts
2440 described in Subsection (12)(a), whether or not for compensation; or
2441 (c) to use, in the conduct of any occupation or profession pertaining to the diagnosis or
2442 treatment of human diseases or conditions, in any printed material, stationery, letterhead,
2443 envelopes, signs, or advertisements, the designation "naturopathic physician," "naturopathic
2444 doctor," "naturopath," "doctor of naturopathic medicine," "doctor of naturopathy,"
2445 "naturopathic medical doctor," "naturopathic medicine," "naturopathic health care,"
2446
2447 might cause a reasonable person to believe the individual using the designation is a licensed
2448 naturopathic physician.
2449 (13) "Prescription drug or device" means:
2450 (a) a drug or device which, under federal law, is required to be labeled with either of
2451 the following statements or their equivalent:
2452 (i) "CAUTION: Federal law prohibits dispensing without prescription"; or
2453 (ii) "CAUTION: Federal law restricts this drug to use by or on the order of a licensed
2454 veterinarian"; or
2455 (b) a drug or device that is required by any applicable federal or state law or rule to be
2456 dispensed on prescription only or is restricted to use by practitioners only.
2457 (14) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-71-501 .
2458 (15) "Unprofessional conduct" is as defined in Sections 58-1-501 and 58-71-502 , and
2459 as may be further defined by division rule.
2460 Section 56. Section 58-71-801 is amended to read:
2461 58-71-801. Disclosure of financial interest by licensee.
2462 (1) Except as provided in Subsection (2), licensees under this chapter may not own,
2463 directly or indirectly:
2464 (a) any [
2465 [
2466 (b) a retail store, wholesaler, distributor, manufacturer, or facility of any other kind
2467 located in this state that is engaged in the sale, dispensing, delivery, distribution, or
2468 manufacture of homeopathic remedies, dietary supplements, or natural medicines.
2469 (2) A licensee may own or control less than 5% of the outstanding stock of a
2470 corporation whose ownership is prohibited under Subsection (1), if the stock of the corporation
2471 is publicly traded.
2472 (3) Licensees under this chapter may not refer patients, clients, or customers to any
2473 clinical laboratory, ambulatory or surgical care facilities, or other treatment or rehabilitation
2474 services such as physical therapy, cardiac rehabilitation, or radiology services in which the
2475 licensee or a member of the licensee's immediate family has any financial relationship as that
2476 term is described in 42 U.S.C. 1395nn, unless the licensee at the time of making the referral
2477
2478 (4) The written disclosure under Subsection [
2479 choose any facility or service center for purpose of having the laboratory work or treatment
2480 service performed.
2481 (5) Licensees under this chapter may not sell from their offices homeopathic remedies
2482 or dietary supplements, as defined in the Federal Food Drug and Cosmetic Act, except for
2483 those products that are not readily available from other local sources.
2484 Section 57. Section 58-73-601 is amended to read:
2485 58-73-601. Scope of practice for a chiropractic physician.
2486 (1) A chiropractic physician licensed under this chapter may engage in the practice of
2487 chiropractic as defined in Section 58-73-102 in accordance with the following standards.
2488 (2) A chiropractic physician may:
2489 (a) examine, diagnose, and treat only within the scope of chiropractic as described in
2490 this Subsection (2);
2491 (b) use x-ray for diagnostic purposes only;
2492 (c) administer:
2493 (i) physical agents, including light, heat, cold, water, air, sound, compression,
2494 electricity, and electromagnetic radiation except gamma radiation; and
2495 (ii) physical activities and devices, including:
2496 (A) exercise with and without devices;
2497 (B) joint mobilization;
2498 (C) mechanical stimulation;
2499 (D) postural drainage;
2500 (E) traction;
2501 (F) positioning;
2502 (G) wound debridement, cleansing, and dressing changes;
2503 (H) splinting;
2504 (I) training in locomotion and other functional activities with and without assistance
2505 devices; and
2506 (J) correction of posture, body mechanics, and gait;
2507 (d) administer the following topically applied medicinal agents, including steroids,
2508
2509 including their use by iontophoresis or phonophoresis;
2510 (e) treat pain incident to major or minor surgery, cancer, obstetrics, or x-ray therapy;
2511 (f) utilize immobilizing appliances, casts, and supports for support purposes, but may
2512 not set displaced bone fractures;
2513 (g) inform the patient of possible side effects of medication and recommend referral to
2514 the prescribing practitioner;
2515 (h) provide instruction in the use of physical measures, activities, and devices for
2516 preventive and therapeutic purposes;
2517 (i) provide consulting, educational, and other advisory services for the purposes of
2518 reducing the incidence and severity of physical disability, movement dysfunctions, bodily
2519 malfunction, and pain;
2520 (j) treat a human being to assess, prevent, correct, alleviate, and limit physical
2521 disability, movement dysfunction, bodily malfunction, and pain resulting from disorders,
2522 congenital and aging conditions, injury, and disease; and
2523 (k) administer, interpret, and evaluate tests.
2524 (3) A chiropractic physician may not:
2525 (a) perform incisive surgery;
2526 (b) administer drugs or medicines for which an authorized prescription is required by
2527 law except as provided in Subsection (2)(d);
2528 (c) treat cancer;
2529 (d) practice obstetrics;
2530 (e) prescribe or administer x-ray therapy; or
2531 (f) set displaced fractures.
2532 (4) A chiropractic physician shall assume responsibility for his examinations,
2533 diagnoses, and treatment.
2534 (5) Nothing in this section authorizes a chiropractic physician to prescribe, possess for
2535 dispensing, dispense, purchase without a prescription written by a licensed and authorized
2536 practitioner, or administer, except under Subsection (2)(d), a drug requiring a prescription to
2537 dispense, under Title 58, Chapter 37, Utah Controlled Substances Act, or Title 58, Chapter
2538 [
2539
2540 physicians, physicians and surgeons, naturopaths, and chiropractic physicians, may diagnose,
2541 adjust, manipulate, or therapeutically position the articulation of the spinal column to the extent
2542 permitted by their scopes of practice.
2543 Section 58. Section 63-55-258 is amended to read:
2544 63-55-258. Repeal dates, Title 58.
2545 (1) Title 58, Chapter 3a, Architects Licensing Act, is repealed July 1, 2013.
2546 (2) Title 58, Chapter 5a, Podiatric Physician Licensing Act, is repealed July 1, 2007.
2547 (3) Title 58, Chapter 9, Funeral Services Licensing Act, is repealed July 1, 2008.
2548 (4) Title 58, Chapter 13, Health Care Providers Immunity from Liability Act, is
2549 repealed July 1, 2006.
2550 (5) Title 58, Chapter 15, Health Facility Administrator Act, is repealed July 1, 2005.
2551 (6) Title 58, Chapter 16a, Utah Optometry Practice Act, is repealed July 1, 2009.
2552 (7) Title 58, Chapter [
2553 2014.
2554 (8) Title 58, Chapter 20a, Environmental Health Scientist Act, is repealed July 1, 2013.
2555 (9) Title 58, Chapter 22, Professional Engineers and Professional Land Surveyors
2556 Licensing Act, is repealed July 1, 2005.
2557 (10) Title 58, Chapter 24a, Physical Therapist Practice Act, is repealed July 1, 2013.
2558 (11) Title 58, Chapter 26a, Certified Public Accountant Licensing Act, is repealed July
2559 1, 2007.
2560 (12) Title 58, Chapter 28, Veterinary Practice Act, is repealed July 1, 2004.
2561 (13) Title 58, Chapter 31b, Nurse Practice Act, is repealed July 1, 2005.
2562 (14) Title 58, Chapter 37, Utah Controlled Substances Act, is repealed July 1, 2007.
2563 (15) Title 58, Chapter 37a, Utah Drug Paraphernalia Act, is repealed July 1, 2007.
2564 (16) Title 58, Chapter 37b, Imitation Controlled Substances Act, is repealed July 1,
2565 2007.
2566 (17) Title 58, Chapter 40, Recreational Therapy Practice Act, is repealed July 1, 2005.
2567 (18) Title 58, Chapter 41, Speech-language Pathology and Audiology Licensing Act, is
2568 repealed July 1, 2009.
2569 (19) Title 58, Chapter 42a, Occupational Therapy Practice Act, is repealed July 1,
2570
2571 (20) Title 58, Chapter 44a, Nurse Midwife Practice Act, is repealed July 1, 2010.
2572 (21) Title 58, Chapter 46a, Hearing Instrument Specialist Licensing Act, is repealed
2573 July 1, 2013.
2574 (22) Title 58, Chapter 47b, Massage Therapy Practice Act, is repealed July 1, 2004.
2575 (23) Title 58, Chapter 49, Dietitian Certification Act, is repealed July 1, 2005.
2576 (24) Title 58, Chapter 53, Landscape Architects Licensing Act, is repealed July 1,
2577 2008.
2578 (25) Title 58, Chapter 59, Professional Employer Organization Licensing Act, is
2579 repealed July 1, 2007.
2580 (26) Title 58, Chapter 67, Utah Medical Practice Act, is repealed July 1, 2006.
2581 (27) Title 58, Chapter 68, Utah Osteopathic Medical Practice Act, is repealed July 1,
2582 2006.
2583 (28) Title 58, Chapter 69, Dentist and Dental Hygienist Practice Act, is repealed July 1,
2584 2006.
2585 (29) Title 58, Chapter 71, Naturopathic Physician Practice Act, is repealed July 1,
2586 2006.
2587 (30) Title 58, Chapter 72, Acupuncture Licensing Act, is repealed July 1, 2007.
2588 (31) Title 58, Chapter 73, Chiropractic Physician Practice Act, is repealed July 1, 2006.
2589 Section 59. Section 76-5-113 is amended to read:
2590 76-5-113. Surreptitious administration of certain substances -- Definitions --
2591 Penalties -- Defenses.
2592 (1) As used in this section:
2593 (a) "Administer" means the introduction of a substance into the body by injection,
2594 inhalation, ingestion, or by any other means.
2595 (b) "Alcoholic beverage" has the same meaning as "alcoholic beverages" in Section
2596 32A-1-105 .
2597 (c) "Bodily injury" has the same definition as in Section 76-1-601 .
2598 (d) "Controlled substance" has the same definition as in Section 58-37-2 .
2599 (e) "Deleterious substance" means a substance which, if administered, would likely
2600 cause bodily injury.
2601
2602 bodily injury or death.
2603 (g) "Prescription drug" has the same definition as in Section [
2604 (h) "Serious bodily injury" has the same definition as in Section 19-2-115 .
2605 (i) "Substance" means a controlled substance, poisonous substance, or deleterious
2606 substance as defined in this Subsection (1).
2607 (2) In addition to any other offense the actor's conduct may constitute, it is a criminal
2608 offense for a person, surreptitiously or by means of fraud, deception, or misrepresentation, to
2609 cause another person to unknowingly consume or receive the administration of:
2610 (a) any poisonous, deleterious, or controlled substance; or
2611 (b) any alcoholic beverage.
2612 (3) A violation of Subsection (2) is:
2613 (a) a second degree felony if the substance is a poisonous substance, regardless of
2614 whether the substance is a controlled substance or a prescription drug;
2615 (b) a third degree felony if the substance is not within the scope of Subsection (3)(a),
2616 and is a controlled substance or a prescription drug; and
2617 (c) a class A misdemeanor if the substance is a deleterious substance or an alcoholic
2618 beverage.
2619 (4) (a) It is an affirmative defense to a prosecution under Subsection (2) that the actor:
2620 (i) provided the appropriate administration of a prescription drug; and
2621 (ii) acted on the reasonable belief that his conduct was in the best interest of the
2622 well-being of the person to whom the prescription drug was administered.
2623 (b) (i) The defendant shall file and serve on the prosecuting attorney a notice in writing
2624 of his intention to claim a defense under Subsection (4)(a) not fewer than 20 days before the
2625 trial.
2626 (ii) The notice shall specifically identify the factual basis for the defense and the names
2627 and addresses of the witnesses the defendant proposes to examine to establish the defense.
2628 (c) The prosecuting attorney shall file and serve the defendant with a notice containing
2629 the names and addresses of the witnesses the prosecutor proposes to examine in order to
2630 contradict or rebut the defendant's claim of an affirmative defense under Subsection (4)(a).
2631 This notice shall be filed or served not more than ten days after receipt of the defendant's notice
2632
2633 (d) (i) Failure of a party to comply with the requirements of Subsection (4)(b) or (4)(c)
2634 entitles the opposing party to a continuance to allow for preparation.
2635 (ii) If the court finds that a party's failure to comply is the result of bad faith, it may
2636 impose appropriate sanctions.
2637 (5) This section does not diminish the scope of authorized health care by a health care
2638 provider as defined in Section 26-23a-1 .
2639 Section 60. Section 76-8-311.3 is amended to read:
2640 76-8-311.3. Items prohibited in correctional and mental health facilities --
2641 Penalties.
2642 (1) As used in this section:
2643 (a) "Contraband" means any item not specifically prohibited for possession by
2644 offenders under this section or Title 58, Chapter 37, Utah Controlled Substances Act.
2645 (b) "Controlled substance" means any substance defined as a controlled substance
2646 under Title 58, Chapter 37, Utah Controlled Substances Act.
2647 (c) "Correctional facility" means:
2648 (i) any facility operated by or contracting with the Department of Corrections to house
2649 offenders in either a secure or nonsecure setting;
2650 (ii) any facility operated by a municipality or a county to house or detain criminal
2651 offenders;
2652 (iii) any juvenile detention facility; and
2653 (iv) any building or grounds appurtenant to the facility or lands granted to the state,
2654 municipality, or county for use as a correctional facility.
2655 (d) "Medicine" means any prescription drug as defined in Title 58, Chapter [
2656 Pharmacy Practice Act, but does not include any controlled substances as defined in Title 58,
2657 Chapter 37, Utah Controlled Substances Act.
2658 (e) "Mental health facility" has the same meaning as defined in Section 62A-15-602 .
2659 (f) "Offender" means a person in custody at a correctional facility.
2660 (g) "Secure area" has the same meaning as provided in Section 76-8-311.1 .
2661 (2) Notwithstanding Section 76-10-500 , a correctional or mental health facility may
2662 provide by rule that no firearm, ammunition, dangerous weapon, implement of escape,
2663
2664 quantity may be:
2665 (a) transported to or upon a correctional or mental health facility;
2666 (b) sold or given away at any correctional or mental health facility;
2667 (c) given to or used by any offender at a correctional or mental health facility; or
2668 (d) knowingly or intentionally possessed at a correctional or mental health facility.
2669 (3) It is a defense to any prosecution under this section if the accused in committing the
2670 act made criminal by this section:
2671 (a) with respect to a correctional facility operated by the Department of Corrections,
2672 acted in conformity with departmental rule or policy;
2673 (b) with respect to a correctional facility operated by a municipality, acted in
2674 conformity with the policy of the municipality;
2675 (c) with respect to a correctional facility operated by a county, acted in conformity with
2676 the policy of the county; or
2677 (d) with respect to a mental health facility, acted in conformity with the policy of the
2678 mental health facility.
2679 (4) (a) Any person who transports to or upon a correctional facility, or into a secure
2680 area of a mental health facility, any firearm, ammunition, dangerous weapon, or implement of
2681 escape with intent to provide or sell it to any offender, is guilty of a second degree felony.
2682 (b) Any person who provides or sells to any offender at a correctional facility, or any
2683 detainee at a secure area of a mental health facility, any firearm, ammunition, dangerous
2684 weapon, or implement of escape is guilty of a second degree felony.
2685 (c) Any offender who possesses at a correctional facility, or any detainee who
2686 possesses at a secure area of a mental health facility, any firearm, ammunition, dangerous
2687 weapon, or implement of escape is guilty of a second degree felony.
2688 (d) Any person who, without the permission of the authority operating the correctional
2689 facility or the secure area of a mental health facility, knowingly possesses at a correctional
2690 facility or a secure area of a mental health facility any firearm, ammunition, dangerous weapon,
2691 or implement of escape is guilty of a third degree felony.
2692 (e) Any person violates Section 76-10-306 who knowingly or intentionally transports,
2693 possesses, distributes, or sells any explosive in a correctional facility or mental health facility.
2694
2695 authority operating the correctional facility or secure area of a mental health facility, knowingly
2696 transports to or upon a correctional facility or into a secure area of a mental health facility any:
2697 (i) spirituous or fermented liquor;
2698 (ii) medicine, whether or not lawfully prescribed for the offender; or
2699 (iii) poison in any quantity.
2700 (b) A person is guilty of a third degree felony who knowingly violates correctional or
2701 mental health facility policy or rule by providing or selling to any offender at a correctional
2702 facility or detainee within a secure area of a mental health facility any:
2703 (i) spirituous or fermented liquor;
2704 (ii) medicine, whether or not lawfully prescribed for the offender; or
2705 (iii) poison in any quantity.
2706 (c) An inmate is guilty of a third degree felony who, in violation of correctional or
2707 mental health facility policy or rule, possesses at a correctional facility or in a secure area of a
2708 mental health facility any:
2709 (i) spirituous or fermented liquor;
2710 (ii) medicine, other than medicine provided by the facility's health care providers in
2711 compliance with facility policy; or
2712 (iii) poison in any quantity.
2713 (d) A person is guilty of a class A misdemeanor who, without the permission of the
2714 authority operating the correctional or mental health facility, fails to declare or knowingly
2715 possesses at a correctional facility or in a secure area of a mental health facility any:
2716 (i) spirituous or fermented liquor;
2717 (ii) medicine; or
2718 (iii) poison in any quantity.
2719 (e) A person is guilty of a class B misdemeanor who, without the permission of the
2720 authority operating the facility, knowingly engages in any activity that would facilitate the
2721 possession of any contraband by an offender in a correctional facility.
2722 (f) Exemptions may be granted for worship for Native American inmates pursuant to
2723 Section 64-13-40 .
2724 (6) The possession, distribution, or use of a controlled substance at a correctional
2725
2726 Title 58, Chapter 37, Utah Controlled Substances Act.
2727 Section 61. Section 78-11-22.2 is amended to read:
2728 78-11-22.2. Donation of nonschedule drugs or devices -- Liability limitation.
2729 (1) As used in this section:
2730 (a) "Administer" is as defined in Section [
2731 (b) "Dispense" is as defined in Section [
2732 (c) "Distribute" is as defined in Section [
2733 (d) "Drug outlet" means:
2734 (i) [
2735 [
2736 (ii) a person with the authority to engage in the dispensing, delivering, manufacturing,
2737 or wholesaling of prescription drugs or devices outside of the state under the law of the
2738 jurisdiction in which the person operates.
2739 (e) "Health care provider" means:
2740 (i) a person who is a health care provider, as defined in Section 78-14-3 , with the
2741 authority under Title 58, Occupations and Professions, to prescribe, dispense, or administer
2742 prescription drugs or devices; or
2743 (ii) a person outside of the state with the authority to prescribe, dispense, or administer
2744 prescription drugs or devices under the law of the jurisdiction in which the person practices.
2745 (f) "Nonschedule drug or device" means:
2746 (i) a prescription drug or device, as defined in Section [
2747 except that it does not include controlled substances, as defined in Section 58-37-2 ; or
2748 (ii) a nonprescription drug, as defined in Section [
2749 (g) "Prescription drug or device" is as defined in Section [
2750 (2) A drug outlet is not subject to civil liability for an injury or death resulting from the
2751 defective condition of a nonschedule drug or device that the drug outlet distributes at no
2752 charge, in good faith, and for a charitable purpose to a drug outlet or health care provider for
2753 ultimate use by a needy person, provided that:
2754 (a) the drug outlet complies with applicable state and federal laws regarding the
2755 storage, handling, and distribution of the nonschedule drug or device; and
2756
2757 constitutes gross negligence, recklessness, or intentional misconduct.
2758 (3) A health care provider is not subject to civil liability for an injury or death resulting
2759 from the defective condition of a nonschedule drug or device that the health care provider
2760 distributes to a drug outlet or health care provider for ultimate use by a needy person or directly
2761 administers, dispenses, or distributes to a needy person, provided that:
2762 (a) the health care provider complies with applicable state and federal laws regarding
2763 the storage, handling, distribution, dispensing, and administration of the nonschedule drug or
2764 device;
2765 (b) the injury or death is not the result of any act or omission of the health care
2766 provider that constitutes gross negligence, recklessness, or intentional misconduct; and
2767 (c) in the event that the health care provider directly administers, distributes, or
2768 dispenses the nonschedule drug or device to the needy person, the health care provider has
2769 retained a consent form signed by the needy person that explains the provisions of this section
2770 which extend liability protection for charitable donations of nonschedule drugs and devices.
2771 (4) Nothing in this section may be construed as:
2772 (a) permitting a person who is not authorized under Title 58, Occupations and
2773 Professions, to operate as a drug outlet or practice as a health care provider within the state; or
2774 (b) extending liability protection to any person who acts outside of the scope of
2775 authority granted to that person under the laws of this state or the jurisdiction in which the
2776 person operates or practices.
2777 Section 62. Section 78-14-3 is amended to read:
2778 78-14-3. Definitions.
2779 As used in this chapter:
2780 (1) "Audiologist" means a person licensed to practice audiology under Title 58,
2781 Chapter 41, Speech-language Pathology and Audiology Licensing Act.
2782 (2) "Certified social worker" means a person licensed to practice as a certified social
2783 worker under Section [
2784 (3) "Chiropractic physician" means a person licensed to practice chiropractic under
2785 Title 58, Chapter 73, Chiropractic Physician Practice Act.
2786 (4) "Clinical social worker" means a person licensed to practice as a clinical social
2787
2788 (5) "Commissioner" means the commissioner of insurance as provided in Section
2789 31A-2-102 .
2790 (6) "Dental hygienist" means a person licensed to practice dental hygiene as defined in
2791 Section 58-69-102 .
2792 (7) "Dentist" means a person licensed to practice dentistry as defined in Section
2793 58-69-102 .
2794 (8) "Division" means the Division of Occupational and Professional Licensing created
2795 in Section 58-1-103 .
2796 (9) "Future damages" includes damages for future medical treatment, care or custody,
2797 loss of future earnings, loss of bodily function, or future pain and suffering of the judgment
2798 creditor.
2799 (10) "Health care" means any act or treatment performed or furnished, or which should
2800 have been performed or furnished, by any health care provider for, to, or on behalf of a patient
2801 during the patient's medical care, treatment, or confinement.
2802 (11) "Health care facility" means general acute hospitals, specialty hospitals, home
2803 health agencies, hospices, nursing care facilities, assisted living facilities, birthing centers,
2804 ambulatory surgical facilities, small health care facilities, health care facilities owned or
2805 operated by health maintenance organizations, and end stage renal disease facilities.
2806 (12) "Health care provider" includes any person, partnership, association, corporation,
2807 or other facility or institution who causes to be rendered or who renders health care or
2808 professional services as a hospital, health care facility, physician, registered nurse, licensed
2809 practical nurse, nurse-midwife, dentist, dental hygienist, optometrist, clinical laboratory
2810 technologist, pharmacist, physical therapist, podiatric physician, psychologist, chiropractic
2811 physician, naturopathic physician, osteopathic physician, osteopathic physician and surgeon,
2812 audiologist, speech-language pathologist, clinical social worker, certified social worker, social
2813 service worker, marriage and family counselor, practitioner of obstetrics, or others rendering
2814 similar care and services relating to or arising out of the health needs of persons or groups of
2815 persons and officers, employees, or agents of any of the above acting in the course and scope of
2816 their employment.
2817 (13) "Hospital" means a public or private institution licensed under Title 26, Chapter
2818
2819 (14) "Licensed practical nurse" means a person licensed to practice as a licensed
2820 practical nurse as provided in Section 58-31b-301 .
2821 (15) "Malpractice action against a health care provider" means any action against a
2822 health care provider, whether in contract, tort, breach of warranty, wrongful death, or
2823 otherwise, based upon alleged personal injuries relating to or arising out of health care rendered
2824 or which should have been rendered by the health care provider.
2825 (16) "Marriage and family therapist" means a person licensed to practice as a marriage
2826 therapist or family therapist under [
2827 58-60-405 .
2828 (17) "Naturopathic physician" means a person licensed to practice naturopathy as
2829 defined in Section 58-71-102 .
2830 (18) "Nurse-midwife" means a person licensed to engage in practice as a nurse midwife
2831 under Section 58-44a-301 .
2832 (19) "Optometrist" means a person licensed to practice optometry under Title 58,
2833 Chapter 16a, Utah Optometry Practice Act.
2834 (20) "Osteopathic physician" means a person licensed to practice osteopathy under
2835 Title 58, Chapter 68, Utah Osteopathic Medical Practice Act.
2836 (21) "Patient" means a person who is under the care of a health care provider, under a
2837 contract, express or implied.
2838 (22) "Pharmacist" means a person licensed to practice pharmacy as provided in Section
2839 [
2840 (23) "Physical therapist" means a person licensed to practice physical therapy under
2841 Title 58, Chapter 24a, Physical Therapist Practice Act.
2842 (24) "Physician" means a person licensed to practice medicine and surgery under Title
2843 58, Chapter 67, Utah Medical Practice Act.
2844 (25) "Podiatric physician" means a person licensed to practice podiatry under Title 58,
2845 Chapter 5a, Podiatric Physician Licensing Act.
2846 (26) "Practitioner of obstetrics" means a person licensed to practice as a physician in
2847 this state under Title 58, Chapter 67, Utah Medical Practice Act, or under Title 58, Chapter 68,
2848 Utah Osteopathic Medical Practice Act.
2849
2850 Licensing Act, to practice psychology as defined in Section 58-61-102 .
2851 (28) "Registered nurse" means a person licensed to practice professional nursing as
2852 provided in Section 58-31b-301 .
2853 (29) "Representative" means the spouse, parent, guardian, trustee, attorney-in-fact, or
2854 other legal agent of the patient.
2855 (30) "Social service worker" means a person licensed to practice as a social service
2856 worker under Section 58-60-205 .
2857 (31) "Speech-language pathologist" means a person licensed to practice
2858 speech-language pathology under Title 58, Chapter 41, Speech-language Pathology and
2859 Audiology Licensing Act.
2860 (32) "Tort" means any legal wrong, breach of duty, or negligent or unlawful act or
2861 omission proximately causing injury or damage to another.
2862 Section 63. Repealer.
2863 This bill repeals:
2864 Section 58-17a-101, Title.
2865 Section 58-17a-102, Definitions.
2866 Section 58-17a-103, Administrative inspections.
2867 Section 58-17a-201, Board -- Membership -- Qualifications -- Terms.
2868 Section 58-17a-301, License required -- Licensure classifications for individuals.
2869 Section 58-17a-302, Qualifications for licensure of pharmacist, pharmacy
2870 technician, and pharmacy intern.
2871 Section 58-17a-304, Term of license -- Expiration -- Renewal.
2872 Section 58-17a-305, Exemptions from licensure.
2873 Section 58-17a-401, Grounds for denial of license -- Disciplinary proceedings.
2874 Section 58-17a-402, Authority to fine drug outlets.
2875 Section 58-17a-501, Unlawful conduct.
2876 Section 58-17a-502, Unprofessional conduct.
2877 Section 58-17a-502.5, Exception to unprofessional conduct.
2878 Section 58-17a-503, Penalty for unlawful conduct.
2879 Section 58-17a-601, General operating standards.
2880
2881 Labels -- Signatures.
2882 Section 58-17a-603, Identification of drug outlet personnel.
2883 Section 58-17a-604, Medication profiles.
2884 Section 58-17a-605, Drug product equivalents.
2885 Section 58-17a-606, Drug substitution is not the practice of medicine -- Other
2886 causes of action not denied.
2887 Section 58-17a-607, Emergency refills.
2888 Section 58-17a-608, Limitation on prescriptions and refills -- Controlled
2889 Substances Act not affected -- Legend drugs.
2890 Section 58-17a-609, Patients' immediate needs.
2891 Section 58-17a-610, Drug outlet records.
2892 Section 58-17a-611, Supervision -- Pharmacist-in-charge.
2893 Section 58-17a-612, Patient counseling.
2894 Section 58-17a-613, Change of ownership or location.
2895 Section 58-17a-614, Branch pharmacies.
2896 Section 58-17a-615, Sale of prescription drugs not in normal course of business.
2897 Section 58-17a-616, Drug stock sales -- Labeling.
2898 Section 58-17a-617, Limitations on distribution of prescription drugs by
2899 pharmaceutical manufacturers or wholesalers.
2900 Section 58-17a-618, Compliance with federal laws.
2901 Section 58-17a-619, Third party payors -- Health maintenance organizations --
2902 Criminal penalty.
2903 Section 58-17a-620, Prescriptions issued within the public health system.
2904 Section 58-17a-701, Penalties.
2905 Section 58-17a-801, Mentally incompetent or incapacitated pharmacist -- Division
2906 action and procedures.
2907 Section 64. Effective date.
2908 This bill takes effect on July 1, 2004.
Legislative Review Note
as of 1-5-04 10:33 AM
A limited legal review of this legislation raises no obvious constitutional or statutory concerns.