First Substitute S.B. 55
This document includes Senate Committee Amendments incorporated into the bill on Thu, Feb 13, 2014 at 9:39 AM by lpoole. --> This document includes Senate 2nd Reading Floor Amendments incorporated into the bill on Tue, Feb 25, 2014 at 2:52 PM by lpoole. -->
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7 LONG TITLE
8 General Description:
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy.
12 Highlighted Provisions:
13 This bill:
14 . defines terms;
15 . establishes the license classification "dispensing medical practitioner" under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug;
17 . establishes the pharmacy facility license classification "dispensing medical
18 practitioner clinic pharmacy" under the Pharmacy Practice Act;
19 . creates Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy;
21 . removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug, injectable weight loss drug, or a cancer
23 drug treatment regimen;
24 . requires a license as a dispensing medical practitioner for a health care practitioner
25 to dispense:
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27 . a cancer drug treatment regimen; or
28 . a prepackaged drug at an employer sponsored clinic;
29 . requires the Board of Pharmacy to work in conjunction with the affected
30 practitioner governing boards:
31 . for discipline or hearings related to a dispensing medical practitioner; and
32 . to develop the administrative rules in the Pharmacy Practice Act related to a
33 dispensing medical practitioner and a dispensing medical practitioner clinic
34 pharmacy;
35 . establishes that practice as a dispensing medical practitioner does not include:
36 . the use of a vending-type dispensing device; or
37 . the prescription of controlled substances, except as permitted for cancer drug
38 treatment regimens;
39 . amends the reporting requirements for the controlled substance database;
40 . amends unlawful and unprofessional conduct provisions; and
41 . makes technical changes.
42 Money Appropriated in this Bill:
43 None
44 Other Special Clauses:
45 This bill takes effect on July 1, 2014.
46 Utah Code Sections Affected:
47 AMENDS:
48 58-17b-102, as last amended by Laws of Utah 2013, Chapters 52, 166, and 423
49 58-17b-301, as last amended by Laws of Utah 2013, Chapter 52
50 58-17b-302, as last amended by Laws of Utah 2013, Chapter 52
51 58-17b-309, as last amended by Laws of Utah 2013, Chapter 278
52 58-17b-309.6, as enacted by Laws of Utah 2013, Chapter 52
53 58-17b-612, as last amended by Laws of Utah 2013, Chapters 52 and 166
54 58-31b-502, as last amended by Laws of Utah 2012, Chapter 234
55 58-37f-203, as enacted by Laws of Utah 2010, Chapter 287
56 58-67-502, as last amended by Laws of Utah 2012, Chapter 234
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58 58-70a-502, as last amended by Laws of Utah 2012, Chapter 234
59 58-70a-503, as last amended by Laws of Utah 2010, Chapter 37
60 58-83-502, as last amended by Laws of Utah 2012, Chapter 344
61 63I-1-258, as last amended by Laws of Utah 2013, Chapters 55, 87, 222, 278, and 351
62 ENACTS:
63 58-17b-801, Utah Code Annotated 1953
64 58-17b-802, Utah Code Annotated 1953
65 58-17b-803, Utah Code Annotated 1953
66 58-17b-804, Utah Code Annotated 1953
67 58-17b-805, Utah Code Annotated 1953
68 58-17b-806, Utah Code Annotated 1953
69 REPEALS:
70 58-17b-309.5, as enacted by Laws of Utah 2012, Chapter 234
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72 Be it enacted by the Legislature of the state of Utah:
73 Section 1. Section 58-17b-102 is amended to read:
74 58-17b-102. Definitions.
75 In addition to the definitions in Section 58-1-102 , as used in this chapter:
76 (1) "Administering" means:
77 (a) the direct application of a prescription drug or device, whether by injection,
78 inhalation, ingestion, or by any other means, to the body of a human patient or research subject
79 by another person; or
80 (b) the placement by a veterinarian with the owner or caretaker of an animal or group
81 of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
82 means directed to the body of the animal by the owner or caretaker in accordance with written
83 or verbal directions of the veterinarian.
84 (2) "Adulterated drug or device" means a drug or device considered adulterated under
85 21 U.S.C.S. Sec. 351 (2003).
86 (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
87 the purpose of analysis.
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89 used as standards and controls in performing drug monitoring or drug screening analysis if the
90 prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
91 components, organic solvents, or inorganic buffers at a concentration not exceeding one
92 milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
93 use.
94 (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
95 the use of prescription drugs.
96 (5) "Automated pharmacy systems" includes mechanical systems which perform
97 operations or activities, other than compounding or administration, relative to the storage,
98 packaging, dispensing, or distribution of medications, and which collect, control, and maintain
99 all transaction information.
100 (6) "Beyond use date" means the date determined by a pharmacist and placed on a
101 prescription label at the time of dispensing that indicates to the patient or caregiver a time
102 beyond which the contents of the prescription are not recommended to be used.
103 (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
104 in Section 58-17b-201 .
105 (8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
106 underserved area, used for the storage and dispensing of prescription drugs, which is dependent
107 upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
108 approved by the division as the parent pharmacy.
109 (9) "Centralized prescription processing" means the processing by a pharmacy of a
110 request from another pharmacy to fill or refill a prescription drug order or to perform
111 processing functions such as dispensing, drug utilization review, claims adjudication, refill
112 authorizations, and therapeutic interventions.
113 (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
114 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
115 prescription order.
116 (11) "Class B pharmacy":
117 (a) means a pharmacy located in Utah:
118 (i) that is authorized to provide pharmaceutical care for patients in an institutional
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120 (ii) whose primary purpose is to provide a physical environment for patients to obtain
121 health care services; and
122 (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
123 (ii) pharmaceutical administration and sterile product preparation facilities.
124 (12) "Class C pharmacy" means a pharmacy located in Utah that is authorized to
125 engage in the manufacture, production, wholesale, or distribution of drugs or devices.
126 (13) "Class D pharmacy" means a nonresident pharmacy.
127 (14) "Class E pharmacy" means all other pharmacies.
128 (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
129 defined and exclusive group of patients who have access to the services of the pharmacy
130 because they are treated by or have an affiliation with a specific entity, including a health
131 maintenance organization or an infusion company, but not including a hospital pharmacy, a
132 retailer of goods to the general public, or the office of a practitioner.
133 (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
134 more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
135 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
136 care functions authorized by the practitioner or practitioners under certain specified conditions
137 or limitations.
138 (17) "Collaborative pharmacy practice agreement" means a written and signed
139 agreement between one or more pharmacists and one or more practitioners that provides for
140 collaborative pharmacy practice for the purpose of drug therapy management of patients and
141 prevention of disease of human subjects.
142 (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
143 labeling of a limited quantity drug, sterile product, or device:
144 (i) as the result of a practitioner's prescription order or initiative based on the
145 practitioner, patient, or pharmacist relationship in the course of professional practice;
146 (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
147 not for sale or dispensing; or
148 (iii) in anticipation of prescription drug orders based on routine, regularly observed
149 prescribing patterns.
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151 (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
152 another pharmacist or pharmaceutical facility;
153 (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
154 dosage form which is regularly and commonly available from a manufacturer in quantities and
155 strengths prescribed by a practitioner; or
156 (iii) the preparation of a prescription drug, sterile product, or device which has been
157 withdrawn from the market for safety reasons.
158 (19) "Confidential information" has the same meaning as "protected health
159 information" under the Standards for Privacy of Individually Identifiable Health Information,
160 45 C.F.R. Parts 160 and 164.
161 (20) "Controlled substance" has the same definition as in Section 58-37-2 .
162 (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
163 417, Sec. 3a(ff) which is incorporated by reference.
164 (22) "Dispense" means the interpretation, evaluation, and implementation of a
165 prescription drug order or device or nonprescription drug or device under a lawful order of a
166 practitioner in a suitable container appropriately labeled for subsequent administration to or use
167 by a patient, research subject, or an animal.
168 (23) "Dispensing medical practitioner" means an individual who is:
169 (a) currently licensed as:
170 (i) a physician and surgeon under Chapter 67, Utah Medical Practice Act;
171 (ii) an osteopathic physician and surgeon under Chapter 68, Utah Osteopathic Medical
172 Practice Act;
173 (iii) a physician assistant under Chapter 70a, Physician Assistant Act;
174 (iv) a nurse practitioner under Chapter 31b, Nurse Practice Act; or
175 (v) an optometrist under Chapter 16a, Utah Optometry Practice Act, if the optometrist
176 is acting within the scope of practice for an optometrist; and
177 (b) licensed by the division under the Pharmacy Practice Act to engage in the practice
178 of a dispensing medical practitioner.
179 (24) "Dispensing medical practitioner clinic pharmacy" means a closed-door pharmacy
180 located within a licensed dispensing medical practitioner's place of practice.
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182 or dispensing.
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184 (i) a substance recognized in the official United States Pharmacopoeia, Official
185 Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
186 supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
187 prevention of disease in humans or animals;
188 (ii) a substance that is required by any applicable federal or state law or rule to be
189 dispensed by prescription only or is restricted to administration by practitioners only;
190 (iii) a substance other than food intended to affect the structure or any function of the
191 body of humans or other animals; and
192 (iv) substances intended for use as a component of any substance specified in
193 Subsections [
194 (b) "Drug" does not include dietary supplements.
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196 (a) evaluation of the prescription drug order and patient record for:
197 (i) known allergies;
198 (ii) rational therapy-contraindications;
199 (iii) reasonable dose and route of administration; and
200 (iv) reasonable directions for use;
201 (b) evaluation of the prescription drug order and patient record for duplication of
202 therapy;
203 (c) evaluation of the prescription drug order and patient record for the following
204 interactions:
205 (i) drug-drug;
206 (ii) drug-food;
207 (iii) drug-disease; and
208 (iv) adverse drug reactions; and
209 (d) evaluation of the prescription drug order and patient record for proper utilization,
210 including over- or under-utilization, and optimum therapeutic outcomes.
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213 intended to be sold, and is intended to be provided to practitioners for the immediate needs of
214 patients for trial purposes or to provide the drug to the patient until a prescription can be filled
215 by the patient.
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217 sound, symbol, or process attached to or logically associated with a record and executed or
218 adopted by a person with the intent to sign the record.
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220 form or the transmission of the exact visual image of a document by way of electronic
221 equipment.
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223 inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
224 under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
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227 division, that may, under the supervision of a pharmacist, perform the activities involved in the
228 technician practice of pharmacy.
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230 licensed to be engaged in the manufacturing of drugs or devices.
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232 (i) the production, preparation, propagation, conversion, or processing of a drug or
233 device, either directly or indirectly, by extraction from substances of natural origin or
234 independently by means of chemical or biological synthesis, or by a combination of extraction
235 and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
236 or relabeling of its container; and
237 (ii) the promotion and marketing of such drugs or devices.
238 (b) "Manufacturing" includes the preparation and promotion of commercially available
239 products from bulk compounds for resale by pharmacies, practitioners, or other persons.
240 (c) "Manufacturing" does not include the preparation or compounding of a drug by a
241 pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
242 compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
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245 prescription drug order.
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247 drugs or devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to
248 analyze the profile to provide pharmaceutical care.
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250 misbranded under 21 U.S.C.S. Sec. 352 (2003).
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252 (i) may be sold without a prescription; and
253 (ii) is labeled for use by the consumer in accordance with federal law.
254 (b) "Nonprescription drug" includes homeopathic remedies.
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256 sells to a person in Utah.
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258 service.
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260 located outside the state that is licensed and in good standing in another state, that:
261 (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
262 this state pursuant to a lawfully issued prescription;
263 (b) provides information to a patient in this state on drugs or devices which may
264 include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
265 or
266 (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
267 effects of drugs.
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269 pharmacist or pharmacy intern of information, to the patient or caregiver, in order to ensure
270 proper use of drugs, devices, and dietary supplements.
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272 institution in which:
273 (a) prescription drugs or devices are held, stored, or are otherwise under the control of
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275 (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
276 or pharmacy intern with whom the facility has established a prescription drug supervising
277 relationship under which the pharmacist or pharmacy intern provides counseling to the facility
278 or agency staff as required, and oversees drug control, accounting, and destruction; and
279 (c) prescription drugs are professionally administered in accordance with the order of a
280 practitioner by an employee or agent of the facility or agency.
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282 with a prescribing practitioner, and in accordance with division rule:
283 (i) designing, implementing, and monitoring a therapeutic drug plan intended to
284 achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
285 the patient's disease;
286 (ii) eliminating or reducing a patient's symptoms; or
287 (iii) arresting or slowing a disease process.
288 (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
289 prescribing practitioner.
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291 delivering, distributing, manufacturing, or wholesaling of prescription drugs or devices within
292 or into this state.
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294 facility engaged in the business of wholesale vending or selling of a prescription drug or device
295 to other than a consumer or user of the prescription drug or device that the pharmaceutical
296 facility has not produced, manufactured, compounded, or dispensed.
297 (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
298 facility carrying out the following business activities:
299 (i) intracompany sales;
300 (ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
301 purchase, or trade a prescription drug or device, if the activity is carried out between one or
302 more of the following entities under common ownership or common administrative control, as
303 defined by division rule:
304 (A) hospitals;
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306 (C) chain pharmacy warehouses, as defined by division rule; or
307 (D) other health care entities, as defined by division rule;
308 (iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
309 purchase, or trade a prescription drug or device, for emergency medical reasons, including
310 supplying another pharmaceutical facility with a limited quantity of a drug, if:
311 (A) the facility is unable to obtain the drug through a normal distribution channel in
312 sufficient time to eliminate the risk of harm to a patient that would result from a delay in
313 obtaining the drug; and
314 (B) the quantity of the drug does not exceed an amount reasonably required for
315 immediate dispensing to eliminate the risk of harm;
316 (iv) the distribution of a prescription drug or device as a sample by representatives of a
317 manufacturer; and
318 (v) the distribution of prescription drugs, if:
319 (A) the dosage units distributed during a calendar year do not exceed five percent of
320 the sum of the dosage units distributed by the facility during the calendar year and the dosage
321 units dispensed by the facility during the calendar year; and
322 (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
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324 practice of pharmacy.
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326 standing who accepts responsibility for the operation of a pharmacy in conformance with all
327 laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is
328 personally in full and actual charge of the pharmacy and all personnel.
329 [
330 one or more years of licensed experience. The preceptor serves as a teacher, example of
331 professional conduct, and supervisor of interns in the professional practice of pharmacy.
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333 (a) drugs are dispensed;
334 (b) pharmaceutical care is provided;
335 (c) drugs are processed or handled for eventual use by a patient; or
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338 provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a
339 self-insured employer, insurance company, health maintenance organization, or other plan
340 sponsor, as defined by rule.
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342 practice as a pharmacy intern.
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344 training program providing education for pharmacy technicians.
345 (55) (a) "Practice as a dispensing medical practitioner" means the practice of pharmacy,
346 specifically relating to the dispensing of a prescription drug in accordance with Part 8,
347 Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, and
348 division rule adopted after consultation with the Board of Pharmacy and the governing boards
349 of the practitioners described in Subsection (23)(a).
350 (b) "Practice as a dispensing medical practitioner" does not include:
351 (i) using a vending-type of dispenser as defined by the division by administrative rule;
352 or
353 (ii) except as permitted by Section 58-17b-805 , dispensing of a controlled substance as
354 defined in Section 58-37-2 .
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356 as a pharmacy technician under the general supervision of a licensed pharmacist and in
357 accordance with a scope of practice defined by division rule made in collaboration with the
358 board.
359 (b) "Practice as a licensed pharmacy technician" does not include:
360 (i) performing a drug utilization review, prescription drug order clarification from a
361 prescriber, final review of the prescription, dispensing of the drug, or counseling a patient with
362 respect to a prescription drug;
363 (ii) except as permitted by rules made by the division in consultation with the board,
364 final review of a prescribed drug prepared for dispensing;
365 (iii) counseling regarding nonprescription drugs and dietary supplements unless
366 delegated by the supervising pharmacist; or
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368 electronically unless the original information is recorded so the pharmacist may review the
369 prescription drug order as transmitted.
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371 (a) providing pharmaceutical care;
372 (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
373 practice agreement;
374 (c) compounding, packaging, labeling, dispensing, administering, and the coincident
375 distribution of prescription drugs or devices, provided that the administration of a prescription
376 drug or device is:
377 (i) pursuant to a lawful order of a practitioner when one is required by law; and
378 (ii) in accordance with written guidelines or protocols:
379 (A) established by the licensed facility in which the prescription drug or device is to be
380 administered on an inpatient basis; or
381 (B) approved by the division, in collaboration with the board and the Physicians
382 Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
383 administered on an outpatient basis solely by a licensed pharmacist;
384 (d) participating in drug utilization review;
385 (e) ensuring proper and safe storage of drugs and devices;
386 (f) maintaining records of drugs and devices in accordance with state and federal law
387 and the standards and ethics of the profession;
388 (g) providing information on drugs or devices, which may include advice relating to
389 therapeutic values, potential hazards, and uses;
390 (h) providing drug product equivalents;
391 (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
392 technicians;
393 (j) providing patient counseling, including adverse and therapeutic effects of drugs;
394 (k) providing emergency refills as defined by rule;
395 (l) telepharmacy; and
396 (m) formulary management intervention.
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400 pharmacy through the use of telecommunications and information technologies that occurs
401 when the patient is physically located within one jurisdiction and the pharmacist is located in
402 another jurisdiction.
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404 otherwise authorized by the appropriate jurisdiction to prescribe and administer drugs in the
405 course of professional practice.
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407 (a) orally or in writing; or
408 (b) by telephone, facsimile transmission, computer, or other electronic means of
409 communication as defined by division rule.
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411 (a) by a licensed practitioner in the course of that practitioner's professional practice or
412 by collaborative pharmacy practice agreement; and
413 (b) for a controlled substance or other prescription drug or device for use by a patient
414 or an animal.
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416 contrivance, implant, in vitro reagent, or other similar or related article, and any component
417 part or accessory, which is required under federal or state law to be prescribed by a practitioner
418 and dispensed by or through a person or entity licensed under this chapter or exempt from
419 licensure under this chapter.
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421 rule to be dispensed only by prescription or is restricted to administration only by practitioners.
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423 (a) conducted in a research facility, as defined by division rule, that is associated with a
424 university or college in the state accredited by the Northwest Commission on Colleges and
425 Universities;
426 (b) requiring the use of a controlled substance, prescription drug, or prescription
427 device;
428 (c) that uses the controlled substance, prescription drug, or prescription device in
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430 approved by an institutional review committee; and
431 (d) that includes any documentation required for the conduct of the research and the
432 handling of the controlled substance, prescription drug, or prescription device.
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434 drugs and devices to the general public.
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436 compliance with this chapter.
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438 operation of the pharmacy during a given day or shift.
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440 (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
441 pharmacy technician in nonjudgmental duties not included in the definition of the practice of
442 pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
443 those duties may be further defined by division rule adopted in collaboration with the board;
444 and
445 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
446 collaboration with the board.
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449 58-17b-502 and may be further defined by rule.
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451 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
452 for animals.
453 Section 2. Section 58-17b-301 is amended to read:
454 58-17b-301. License required -- License classifications for individuals.
455 (1) A license is required to engage in the practice of pharmacy, telepharmacy, [
456
457 provided in Section 58-1-307 [
458 (2) The division shall issue to an individual who qualifies under this chapter a license
459 in the classification of:
460
461 (b) pharmacy intern; [
462 (c) pharmacy technician[
463 (d) dispensing medical practitioner.
464 Section 3. Section 58-17b-302 is amended to read:
465 58-17b-302. License required -- License classifications for pharmacy facilities.
466 (1) A license is required to act as a pharmacy, except as specifically exempted from
467 licensure under Section 58-1-307 [
468 (2) The division shall issue a pharmacy license to a facility that qualifies under this
469 chapter in the classification of a:
470 (a) class A pharmacy;
471 (b) class B pharmacy;
472 (c) class C pharmacy;
473 (d) class D pharmacy; [
474 (e) class E pharmacy[
475 (f) dispensing medical practitioner clinic pharmacy.
476 (3) Each place of business shall require a separate license. If multiple pharmacies exist
477 at the same address, a separate license shall be required for each pharmacy.
478 (4) The division may further define or supplement the classifications of pharmacies.
479 The division may impose restrictions upon classifications to protect the public health, safety,
480 and welfare.
481 (5) Each pharmacy shall have a pharmacist-in-charge, except as otherwise provided by
482 rule.
483 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy,
484 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
485 of the pharmacy, regardless of the form of the business organization.
486 Section 4. Section 58-17b-309 is amended to read:
487 58-17b-309. Exemptions from licensure.
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515 this section without being licensed under this chapter:
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520 58-16a-801 ; or
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523 program as defined in division rule[
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531 Subsection [
532 completion of an approved curriculum of education, within the required time frame. This
533 exemption expires immediately upon notification of a failing score of an examination, and the
534 individual may not continue working as a pharmacy technician even under direct supervision.
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587 Section 5. Section 58-17b-309.6 is amended to read:
588 58-17b-309.6. Exemptions from licensure for research using pharmaceuticals.
589 Research using pharmaceuticals, as defined in Subsection 58-17b-102 [
590 exempt from licensure under Sections 58-17b-301 and 58-17b-302 .
591 Section 6. Section 58-17b-612 is amended to read:
592 58-17b-612. Supervision -- Pharmacist-in-charge.
593 (1) (a) Any pharmacy, except a wholesaler, distributor, out-of-state mail service
594 pharmacy, or class E pharmacy, shall be under the general supervision of at least one
595 pharmacist licensed to practice in Utah. One pharmacist licensed in Utah shall be designated
596 as the pharmacist-in-charge, whose responsibility it is to oversee the operation of the pharmacy.
597 (b) Notwithstanding Subsection 58-17b-102 [
598 not have to be in the pharmacy or care facility but shall be available via a telepharmacy system
599 for immediate contact with the supervised pharmacy technician or pharmacy intern if:
600 (i) the pharmacy is located in:
601 (A) a remote rural hospital, as defined in Section 26-21-13.6 ; or
602 (B) a clinic located in a remote rural county with less than 20 people per square mile;
603 (ii) the supervising pharmacist described in Subsection (1)(a) is not available; and
604 (iii) the telepharmacy system maintains records and files quarterly reports as required
605 by division rule to assure that patient safety is not compromised.
606 (2) Each out-of-state mail service pharmacy shall designate and identify to the division
607 a pharmacist holding a current license in good standing issued by the state in which the
608 pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
609 chapter.
610 Section 7. Section 58-17b-801 is enacted to read:
611
612
613 58-17b-801. Title.
614 This part is known as "Dispensing Medical Practitioner and Dispensing Medical
Senate 2nd Reading Amendments 2-25-2014 lp/cjd
Senate Committee Amendments 2-13-2014 lp/cjd
615
Practitioner Clinic Pharmacy."615
616 Section 8. Section 58-17b-802 is enacted to read:
617 58-17b-802. Definitions.
618 As used in this part:
619 (1) (a) "Cosmetic drug" means a prescription drug that:
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual; and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule; or
624 (B) has been expressly approved for online dispensing, whether or not it is dispensed
625 online or through a physician's office.
626 (b) "Cosmetic drug" does not include a prescription drug that is:
627 (i) a controlled substance;
628 (ii) compounded by the physician; or
629 (iii) prescribed S. for .S or used S. [
629a diagnosing, curing, or
630 preventing a disease.
631 (2) "Employer sponsored clinic" means an entity that S. has a medical director who is
631a licensed as a physician as defined in Section 58-67-102 and .S offers health care only to the
632 employees of an exclusive group of employers and the employees' dependents.
633 (3) "Health care" is as defined in Section 31A-1-301 S. . .S
634 (4) (a) "Injectable weight loss drug" means an injectable prescription drug:
635 (i) prescribed to promote weight loss; and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule.
638 (b) "Injectable weight loss drug" does not include a prescription drug that is a
639 controlled substance.
640 (5) "Prepackaged drug" means a prescription drug that:
641 (a) is not listed under federal or state law as a Schedule I, II, III, IV, or V drug; and
642 (b) is packaged in a fixed quantity per package by:
643 (i) the drug manufacturer;
644 (ii) a pharmaceutical wholesaler or distributor; or
645 (iii) a pharmacy licensed under this title.
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646
Section 9.
Section
58-17b-803
is enacted to read:646
647 58-17b-803. Qualifications for licensure as a dispensing medical practitioner --
648 Scope of practice.
649 (1) An applicant for a license as a dispensing medical practitioner shall:
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-102 (23)(a); and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S. [
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656 58-17b-307 .
657 (3) A dispensing medical practitioner may dispense, in accordance with this part:
658 (a) a cosmetic drug and an injectable weight loss drug if:
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioner's patient; and
661 (ii) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802 (1);
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 ; and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner:
667 (i) treats an employee, or the dependent of an employee, of one of an exclusive group
668 of employers at an employer sponsored clinic;
669 (ii) prescribes a prepackaged drug to the employee or the employee's dependent;
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic; and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling, record keeping, patient counseling, purchasing and
673 distribution, operating, treatment, quality of care, and storage requirements.
674 (4) A dispensing medical practitioner:
675 (a) shall inform the patient:
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
Senate 2nd Reading Amendments 2-25-2014 lp/cjd
677
unaffiliated with the practitioner;677
678 (ii) of the directions for appropriate use of the dispensed drug;
679 (iii) of potential side effects to the use of the dispensed drug; and
680 (iv) how to contact the dispensing medical practitioner if the patient has questions or
681 concerns regarding the drug;
682 (b) shall report to the controlled substance database in the same manner as required in
683 Section 58-37f-203 ; and
684 (c) may delegate the dispensing of the drug if the individual to whom the dispensing
685 was delegated is:
686 (i) employed by the dispensing medical practitioner or the outpatient clinic setting in
687 which the dispensing medical practitioner works; and
688 (ii) acting under the direction of a dispensing medical practitioner who is immediately
689 available on site for any necessary consultation.
690 (5) If the chapter that governs the license of a dispensing medical practitioner, as listed
691 in Subsection 58-17b-102 (23), requires physician supervision in its scope of practice
692 requirements, the dispensing medical practitioner shall only dispense a drug under the
693 supervision of an individual licensed under Chapter 67, Utah Medical Practice Act, or Chapter
694 68, Utah Osteopathic Medical Practice Act S. . .S
695 Section 10. Section 58-17b-804 is enacted to read:
696 58-17b-804. Qualifications for licensure as a dispensing medical practitioner clinic
697 pharmacy.
698 (1) An applicant for a license as a dispensing medical practitioner clinic pharmacy shall
699 comply with Section 58-17b-306 .
700 (2) (a) Notwithstanding Section 58-17b-302 , a pharmacy licensed under this part is not
701 required to have a pharmacist-in-charge if:
702 (i) the pharmacy has designated a dispensing medical practitioner as responsible for all
703 activities of the pharmacy; and
704 (ii) the pharmacy complies with administrative rules adopted by the division in
705 consultation with the Board of Pharmacy and the governing bodies of the practitioners
706 described in Subsection 58-17b-102 (23)(a).
707 (b) Notwithstanding Subsection 58-17b-306 (1)(e), the division, in consultation with
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708
the Board of Pharmacy and the governing boards of the practitioners described in Subsection708
709 58-17b-102 (23)(a), may modify the operating standards for a dispensing medical practitioner
710 clinic pharmacy.
711 Section 11. Section 58-17b-805 is enacted to read:
712 58-17b-805. Dispensing medical practitioner -- Cancer drug treatment regimen.
713 (1) For purposes of this section:
714 (a) "Cancer drug treatment regimen" means a prescription drug used to treat cancer,
715 manage its symptoms, or provide continuity of care for a cancer patient.
716 (b) "Cancer drug treatment regimen" includes:
717 (i) a chemotherapy drug administered intravenously, orally, rectally, or by dermal
718 methods; and
719 (ii) a drug used to support cancer treatment, including a drug S. used .S to treat,
719a alleviate, or
720 minimize physical and psychological symptoms or pain, S. [
720a of
721 cancer treatments S. , .S or S. to .S prepare a patient for a subsequent course of therapy.
722 (c) "Cancer drug treatment regimen" does not mean a drug listed under federal law as a
723 Schedule I, II, or III drug.
724 (2) An individual may be licensed as a dispensing medical practitioner with a scope of
725 practice that permits the dispensing medical practitioner to prescribe and dispense a cancer
726 drug treatment regimen if the individual:
727 (a) is licensed as described in Subsections 58-17b-102 (23)(a)(i) and (ii); and
728 (b) is certified or eligible to be certified by the American Board of Internal Medicine in
729 medical oncology.
730 (3) A dispensing medical practitioner authorized to prescribe and dispense a cancer
731 drug treatment regimen under this section may prescribe and dispense a cancer drug treatment
732 regimen:
733 (a) to the practitioner's patient who is currently undergoing chemotherapy in an
734 outpatient clinic setting; and
735 (b) if the practitioner determines that providing the cancer drug treatment regimen to
736 the patient in the outpatient clinic setting is in the best interest of the patient or provides better
737 access to care for the patient.
738 Section 12. Section 58-17b-806 is enacted to read:
Senate Committee Amendments 2-13-2014 lp/cjd
739
58-17b-806. Dispensing medical practitioner -- Dispensing medical practitioner739
740 clinic pharmacy -- Unprofessional and Unlawful conduct.
741 (1) S. (a) .S The division S. [
742 (a) report a violation of this chapter by a dispensing medical practitioner to
742a with .S the
743 dispensing medical practitioner's appropriate licensing board as designated in Subsection
744 58-17b-102 (23)(a) S. regarding a violation of this chapter .S ; and
745 (b) S. the Pharmacy Board shall, if requested by the licensing board of the dispensing
745a medical practitioner, .S assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter.
747 (2) The division S. [
747a appropriate
748 action against a dispensing medical practitioner, in accordance with this chapter, if the
749 licensing board designated in Subsection 58-17b-102 (23)(a) recommends to the division that
750 action be taken under this chapter.
751 (3) The division, in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804 .
754 Section 13. Section 58-31b-502 is amended to read:
755 58-31b-502. Unprofessional conduct.
756 "Unprofessional conduct" includes:
757 (1) failure to safeguard a patient's right to privacy as to the patient's person, condition,
758 diagnosis, personal effects, or any other matter about which the licensee is privileged to know
759 because of the licensee's or person with a certification's position or practice as a nurse or
760 practice as a medication aide certified;
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patient's human dignity and unique personal character
763 and needs without regard to the patient's race, religion, ethnic background, socioeconomic
764 status, age, sex, or the nature of the patient's health problem;
765 (3) engaging in sexual relations with a patient during any:
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient; or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
770
771 (4) (a) as a result of any circumstance under Subsection (3), exploiting or using
772 information about a patient or exploiting the licensee's or the person with a certification's
773 professional relationship between the licensee or holder of a certification under this chapter and
774 the patient; or
775 (b) exploiting the patient by use of the licensee's or person with a certification's
776 knowledge of the patient obtained while acting as a nurse or a medication aide certified;
777 (5) unlawfully obtaining, possessing, or using any prescription drug or illicit drug;
778 (6) unauthorized taking or personal use of nursing supplies from an employer;
779 (7) unauthorized taking or personal use of a patient's personal property;
780 (8) knowingly entering into any medical record any false or misleading information or
781 altering a medical record in any way for the purpose of concealing an act, omission, or record
782 of events, medical condition, or any other circumstance related to the patient and the medical or
783 nursing care provided;
784 (9) unlawful or inappropriate delegation of nursing care;
785 (10) failure to exercise appropriate supervision of persons providing patient care
786 services under supervision of the licensed nurse;
787 (11) employing or aiding and abetting the employment of an unqualified or unlicensed
788 person to practice as a nurse;
789 (12) failure to file or record any medical report as required by law, impeding or
790 obstructing the filing or recording of such a report, or inducing another to fail to file or record
791 such a report;
792 (13) breach of a statutory, common law, regulatory, or ethical requirement of
793 confidentiality with respect to a person who is a patient, unless ordered by a court;
794 (14) failure to pay a penalty imposed by the division;
795 (15) prescribing a schedule II-III controlled substance without a consulting physician or
796 outside of a consultation and referral plan;
797 (16) violating Section 58-31b-801 ; and
798 (17) violating the dispensing requirements of Section 58-17b-309 or [
799 Chapter 17b, Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner
800 Clinic Pharmacy, if applicable.
801
802 58-37f-203. Submission, collection, and maintenance of data.
803 (1) (a) The pharmacist in charge of the drug outlet where a controlled substance is
804 dispensed shall submit the data described in this section to the division:
805 [
806 [
807 [
808 (b) A dispensing medical practitioner licensed under Chapter 17b, Part 8, Dispensing
809 Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, shall comply with
810 the provisions of this section and the dispensing medical practitioner shall assume the duties of
811 the pharmacist under this chapter.
812 (2) The pharmacist described in Subsection (1) shall, for each controlled substance
813 dispensed by a pharmacist under the pharmacist's supervision other than those dispensed for an
814 inpatient at a health care facility, submit to the division the following information:
815 (a) the name of the prescribing practitioner;
816 (b) the date of the prescription;
817 (c) the date the prescription was filled;
818 (d) the name of the individual for whom the prescription was written;
819 (e) positive identification of the individual receiving the prescription, including the
820 type of identification and any identifying numbers on the identification;
821 (f) the name of the controlled substance;
822 (g) the quantity of the controlled substance prescribed;
823 (h) the strength of the controlled substance;
824 (i) the quantity of the controlled substance dispensed;
825 (j) the dosage quantity and frequency as prescribed;
826 (k) the name of the drug outlet dispensing the controlled substance;
827 (l) the name of the pharmacist dispensing the controlled substance; and
828 (m) other relevant information as required by division rule.
829 (3) (a) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
830 Administrative Rulemaking Act, to establish the electronic format in which the information
831 required under this section shall be submitted to the division.
832
833 reference:
834 (i) the identification of each individual who requests or receives information from the
835 database;
836 (ii) the information provided to each individual; and
837 (iii) the date and time that the information is requested or provided.
838 Section 15. Section 58-67-502 is amended to read:
839 58-67-502. Unprofessional conduct.
840 "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 :
841 (1) using or employing the services of any individual to assist a licensee in any manner
842 not in accordance with the generally recognized practices, standards, or ethics of the
843 profession, state law, or division rule;
844 (2) making a material misrepresentation regarding the qualifications for licensure under
845 Section 58-67-302.7 ; or
846 (3) violating the dispensing requirements of Section 58-17b-309 or [
847 Chapter 17b, Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner
848 Clinic Pharmacy, if applicable.
849 Section 16. Section 58-68-502 is amended to read:
850 58-68-502. Unprofessional conduct.
851 "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 :
852 (1) using or employing the services of any individual to assist a licensee in any manner
853 not in accordance with the generally recognized practices, standards, or ethics of the
854 profession, state law, or division rule; or
855 (2) violating the dispensing requirements of Section 58-17b-309 or [
856 Chapter 17b, Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner
857 Clinic Pharmacy, if applicable.
858 Section 17. Section 58-70a-502 is amended to read:
859 58-70a-502. Unlawful conduct.
860 "Unlawful conduct" includes[
861 while not under the supervision of a supervising physician or substitute supervising physician[
862
863
864
865 Section 18. Section 58-70a-503 is amended to read:
866 58-70a-503. Unprofessional conduct.
867 "Unprofessional conduct" includes:
868 (1) violation of a patient confidence to any person who does not have a legal right and
869 a professional need to know the information concerning the patient;
870 (2) knowingly prescribing, selling, giving away, or directly or indirectly administering,
871 or offering to prescribe, sell, furnish, give away, or administer any prescription drug except for
872 a legitimate medical purpose upon a proper diagnosis indicating use of that drug in the amounts
873 prescribed or provided;
874 (3) prescribing prescription drugs for himself or administering prescription drugs to
875 himself, except those that have been legally prescribed for him by a licensed practitioner and
876 that are used in accordance with the prescription order for the condition diagnosed;
877 (4) failure to maintain at the practice site a delegation of services agreement that
878 accurately reflects current practices;
879 (5) failure to make the delegation of services agreement available to the division for
880 review upon request; [
881 (6) in a practice that has physician assistant ownership interests, failure to allow the
882 supervising physician the independent final decision making authority on patient treatment
883 decisions, as set forth in the delegation of services agreement or as defined by rule[
884 (7) violating the dispensing requirements of Chapter 17b, Part 8, Dispensing Medical
885 Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, if applicable.
886 Section 19. Section 58-83-502 is amended to read:
887 58-83-502. Unprofessional conduct.
888 "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 and
889 as may be further defined by administrative rule:
890 (1) online prescribing, dispensing, or facilitation with respect to a person under the age
891 of 18 years;
892 (2) using the name or official seal of the state, the Utah Department of Commerce, or
893 the Utah Division of Occupational and Professional Licensing, or their boards, in an
894
895 (3) failing to respond promptly to a request by the division for information including:
896 (a) an audit of the website; or
897 (b) records of the online prescriber, the Internet facilitator, or the online contract
898 pharmacy;
899 (4) using an online prescriber, online contract pharmacy, or Internet facilitator without
900 approval of the division;
901 (5) failing to inform a patient of the patient's freedom of choice in selecting who will
902 dispense a prescription in accordance with Subsection 58-83-305 (1)(n);
903 (6) failing to keep the division informed of the name and contact information of the
904 Internet facilitator or online contract pharmacy; and
905 (7) violating the dispensing and labeling requirements of [
906 17b, Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic
907 Pharmacy.
908 Section 20. Section 63I-1-258 is amended to read:
909 63I-1-258. Repeal dates, Title 58.
910 (1) Title 58, Chapter 13, Health Care Providers Immunity from Liability Act, is
911 repealed July 1, 2016.
912 (2) Title 58, Chapter 15, Health Facility Administrator Act, is repealed July 1, 2015.
913 (3) [
914 Environmental Health Scientist Act, is repealed July 1, 2018.
915 [
916 2023.
917 [
918 Act, is repealed July 1, 2019.
919 [
920 2015.
921 [
922 repealed July 1, 2023.
923 [
924 [
925
926 Section 21. Repealer.
927 This bill repeals:
928 Section 58-17b-309.5, Exemption for prescribing practitioner of cancer drug
929 regimen -- Division study of dispensing practitioners.
930 Section 22. Effective date.
931 This bill takes effect on July 1, 2014.
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