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S.B. 280
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7 LONG TITLE
8 General Description:
9 This bill modifies provisions of the Pharmacy Practice Act to allow certain medical
10 practitioners to dispense prescription drugs.
11 Highlighted Provisions:
12 This bill:
13 . defines terms;
14 . establishes the license classification "dispensing medical practitioner" under the
15 Pharmacy Practice Act that permits the following to dispense prescription drugs:
16 . licensed physicians and surgeons;
17 . licensed osteopathic physicians and surgeons;
18 . licensed physician assistants; and
19 . licensed nurse practitioners;
20 . establishes that practice as a dispensing medical practitioner does not include the
21 prescription of a controlled substance; and
22 . makes technical changes.
23 Money Appropriated in this Bill:
24 None
25 Other Special Clauses:
26 None
27 Utah Code Sections Affected:
28 AMENDS:
29 58-17b-102, as last amended by Laws of Utah 2012, Chapters 265 and 320
30 58-17b-612, as last amended by Laws of Utah 2010, Chapter 101
31 ENACTS:
32 58-17b-303.5, Utah Code Annotated 1953
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34 Be it enacted by the Legislature of the state of Utah:
35 Section 1. Section 58-17b-102 is amended to read:
36 58-17b-102. Definitions.
37 In addition to the definitions in Section 58-1-102 , as used in this chapter:
38 (1) "Administering" means:
39 (a) the direct application of a prescription drug or device, whether by injection,
40 inhalation, ingestion, or by any other means, to the body of a human patient or research subject
41 by another person; or
42 (b) the placement by a veterinarian with the owner or caretaker of an animal or group
43 of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
44 means directed to the body of the animal by the owner or caretaker in accordance with written
45 or verbal directions of the veterinarian.
46 (2) "Adulterated drug or device" means a drug or device considered adulterated under
47 21 U.S.C.S. Sec. 351 (2003).
48 (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
49 the purpose of analysis.
50 (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
51 used as standards and controls in performing drug monitoring or drug screening analysis if the
52 prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
53 components, organic solvents, or inorganic buffers at a concentration not exceeding one
54 milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
55 use.
56 (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
57 the use of prescription drugs.
58 (5) "Automated pharmacy systems" includes mechanical systems which perform
59 operations or activities, other than compounding or administration, relative to the storage,
60 packaging, dispensing, or distribution of medications, and which collect, control, and maintain
61 all transaction information.
62 (6) "Beyond use date" means the date determined by a pharmacist and placed on a
63 prescription label at the time of dispensing that indicates to the patient or caregiver a time
64 beyond which the contents of the prescription are not recommended to be used.
65 (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
66 in Section 58-17b-201 .
67 (8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
68 underserved area, used for the storage and dispensing of prescription drugs, which is dependent
69 upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
70 approved by the division as the parent pharmacy.
71 (9) "Centralized prescription processing" means the processing by a pharmacy of a
72 request from another pharmacy to fill or refill a prescription drug order or to perform
73 processing functions such as dispensing, drug utilization review, claims adjudication, refill
74 authorizations, and therapeutic interventions.
75 (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
76 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
77 prescription order.
78 (11) "Class B pharmacy":
79 (a) means a pharmacy located in Utah:
80 (i) that is authorized to provide pharmaceutical care for patients in an institutional
81 setting; and
82 (ii) whose primary purpose is to provide a physical environment for patients to obtain
83 health care services; and
84 (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
85 (ii) pharmaceutical administration and sterile product preparation facilities.
86 (12) "Class C pharmacy" means a pharmacy located in Utah that is authorized to
87 engage in the manufacture, production, wholesale, or distribution of drugs or devices.
88 (13) "Class D pharmacy" means a nonresident pharmacy.
89 (14) "Class E pharmacy" means all other pharmacies.
90 (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
91 defined and exclusive group of patients who have access to the services of the pharmacy
92 because they are treated by or have an affiliation with a specific entity, including a health
93 maintenance organization or an infusion company, but not including a hospital pharmacy, a
94 retailer of goods to the general public, or the office of a practitioner.
95 (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
96 more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
97 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
98 care functions authorized by the practitioner or practitioners under certain specified conditions
99 or limitations.
100 (17) "Collaborative pharmacy practice agreement" means a written and signed
101 agreement between one or more pharmacists and one or more practitioners that provides for
102 collaborative pharmacy practice for the purpose of drug therapy management of patients and
103 prevention of disease of human subjects.
104 (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
105 labeling of a limited quantity drug, sterile product, or device:
106 (i) as the result of a practitioner's prescription order or initiative based on the
107 practitioner, patient, or pharmacist relationship in the course of professional practice;
108 (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
109 not for sale or dispensing; or
110 (iii) in anticipation of prescription drug orders based on routine, regularly observed
111 prescribing patterns.
112 (b) "Compounding" does not include:
113 (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
114 another pharmacist or pharmaceutical facility;
115 (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
116 dosage form which is regularly and commonly available from a manufacturer in quantities and
117 strengths prescribed by a practitioner; or
118 (iii) the preparation of a prescription drug, sterile product, or device which has been
119 withdrawn from the market for safety reasons.
120 (19) "Confidential information" has the same meaning as "protected health
121 information" under the Standards for Privacy of Individually Identifiable Health Information,
122 45 C.F.R. Parts 160 and 164.
123 (20) "Controlled substance" has the same definition as in Section 58-37-2 .
124 (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
125 417, Sec. 3a(ff) which is incorporated by reference.
126 (22) "Dispense" means the interpretation, evaluation, and implementation of a
127 prescription drug order or device or nonprescription drug or device under a lawful order of a
128 practitioner in a suitable container appropriately labeled for subsequent administration to or use
129 by a patient, research subject, or an animal.
130 (23) "Dispensing medical practitioner" means an individual who is:
131 (a) currently licensed as:
132 (i) a physician and surgeon under Title 58, Chapter 67, Utah Medical Practice Act;
133 (ii) an osteopathic physician and surgeon under Title 58, Chapter 68, Utah Osteopathic
134 Medical Practice Act;
135 (iii) a physician assistant under Title 58, Chapter 70, Physician Assistant Act; or
136 (iv) a nurse practitioner under Title 58, Chapter 31b, Nurse Practice Act; and
137 (b) licensed by this state to engage in practice as a dispensing medical practitioner.
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139 or dispensing.
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141 (i) a substance recognized in the official United States Pharmacopoeia, Official
142 Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
143 supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
144 prevention of disease in humans or animals;
145 (ii) a substance that is required by any applicable federal or state law or rule to be
146 dispensed by prescription only or is restricted to administration by practitioners only;
147 (iii) a substance other than food intended to affect the structure or any function of the
148 body of humans or other animals; and
149 (iv) substances intended for use as a component of any substance specified in
150 Subsections [
151 (b) "Drug" does not include dietary supplements.
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153 therapeutic equivalent of another drug product in the Approved Drug Products with
154 Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
155 of the Federal Food and Drug Administration.
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157 (a) evaluation of the prescription drug order and patient record for:
158 (i) known allergies;
159 (ii) rational therapy-contraindications;
160 (iii) reasonable dose and route of administration; and
161 (iv) reasonable directions for use;
162 (b) evaluation of the prescription drug order and patient record for duplication of
163 therapy;
164 (c) evaluation of the prescription drug order and patient record for the following
165 interactions:
166 (i) drug-drug;
167 (ii) drug-food;
168 (iii) drug-disease; and
169 (iv) adverse drug reactions; and
170 (d) evaluation of the prescription drug order and patient record for proper utilization,
171 including over- or under-utilization, and optimum therapeutic outcomes.
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173 consistent with limited dosage therapy of the particular drug, which is marked "sample", is not
174 intended to be sold, and is intended to be provided to practitioners for the immediate needs of
175 patients for trial purposes or to provide the drug to the patient until a prescription can be filled
176 by the patient.
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178 sound, symbol, or process attached to or logically associated with a record and executed or
179 adopted by a person with the intent to sign the record.
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181 form or the transmission of the exact visual image of a document by way of electronic
182 equipment.
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184 coordinated practical experience program in a health care setting under the supervision of a
185 preceptor, as defined in this act, and approved by a college of pharmacy.
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187 inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
188 under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
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191 division, that may, under the supervision of a pharmacist, perform the activities involved in the
192 technician practice of pharmacy.
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194 licensed to be engaged in the manufacturing of drugs or devices.
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196 (i) the production, preparation, propagation, conversion, or processing of a drug or
197 device, either directly or indirectly, by extraction from substances of natural origin or
198 independently by means of chemical or biological synthesis, or by a combination of extraction
199 and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
200 or relabeling of its container; and
201 (ii) the promotion and marketing of such drugs or devices.
202 (b) "Manufacturing" includes the preparation and promotion of commercially available
203 products from bulk compounds for resale by pharmacies, practitioners, or other persons.
204 (c) "Manufacturing" does not include the preparation or compounding of a drug by a
205 pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
206 compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
207 analysis.
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209 prescription drug order.
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211 drugs or devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to
212 analyze the profile to provide pharmaceutical care.
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214 misbranded under 21 U.S.C.S. Sec. 352 (2003).
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216 (i) may be sold without a prescription; and
217 (ii) is labeled for use by the consumer in accordance with federal law.
218 (b) "Nonprescription drug" includes homeopathic remedies.
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220 sells to a person in Utah.
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222 service.
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224 located outside the state that is licensed and in good standing in another state, that:
225 (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
226 this state pursuant to a lawfully issued prescription;
227 (b) provides information to a patient in this state on drugs or devices which may
228 include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
229 or
230 (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
231 effects of drugs.
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233 pharmacist or pharmacy intern of information, to the patient or caregiver, in order to ensure
234 proper use of drugs, devices, and dietary supplements.
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236 institution in which:
237 (a) prescription drugs or devices are held, stored, or are otherwise under the control of
238 the facility or agency for administration to patients of that facility or agency;
239 (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
240 or pharmacy intern with whom the facility has established a prescription drug supervising
241 relationship under which the pharmacist or pharmacy intern provides counseling to the facility
242 or agency staff as required, and oversees drug control, accounting, and destruction; and
243 (c) prescription drugs are professionally administered in accordance with the order of a
244 practitioner by an employee or agent of the facility or agency.
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246 with a prescribing practitioner, and in accordance with division rule:
247 (i) designing, implementing, and monitoring a therapeutic drug plan intended to
248 achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
249 the patient's disease;
250 (ii) eliminating or reducing a patient's symptoms; or
251 (iii) arresting or slowing a disease process.
252 (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
253 prescribing practitioner.
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255 delivering, distributing, manufacturing, or wholesaling of prescription drugs or devices within
256 or into this state.
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258 facility engaged in the business of wholesale vending or selling of any prescription drug or
259 device to other than the consumer or user of the prescription drug or device, which the
260 pharmaceutical facility has not produced, manufactured, compounded, or dispensed.
261 (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
262 facility carrying out the following business activities:
263 (i) intracompany sales;
264 (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
265 purchase or trade a prescription drug or device between hospitals or other health care facilities
266 that are under common ownership or control of the management and operation of the facilities;
267 (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
268 purchase, or trade a prescription drug or device for emergency medical reasons, or to supply
269 another pharmaceutical facility to alleviate a temporary shortage; or
270 (iv) the distribution of a prescription drug or device as a sample by representatives of a
271 manufacturer.
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273 practice of pharmacy.
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275 standing who accepts responsibility for the operation of a pharmacy in conformance with all
276 laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is
277 personally in full and actual charge of the pharmacy and all personnel.
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279 one or more years of licensed experience. The preceptor serves as a teacher, example of
280 professional conduct, and supervisor of interns in the professional practice of pharmacy.
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282 (a) drugs are dispensed;
283 (b) pharmaceutical care is provided;
284 (c) drugs are processed or handled for eventual use by a patient; or
285 (d) drugs are used for the purpose of analysis or research.
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287 provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a
288 self-insured employer, insurance company, health maintenance organization, or other plan
289 sponsor, as defined by rule.
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291 practice as a pharmacy intern.
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293 training program providing education for pharmacy technicians.
294 (56) (a) "Practice as a licensed dispensing medical practitioner" means the practice of
295 pharmacy, specifically relating to the dispensing of a prescription drug in accordance with the
296 scope of practice defined in division rule in collaboration with the board.
297 (b) "Practice as a licensed dispensing medical practitioner" does not include dispensing
298 a controlled substance as defined in Section 58-37-2 .
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300 as a pharmacy technician under the general supervision of a licensed pharmacist and in
301 accordance with a scope of practice defined by division rule made in collaboration with the
302 board.
303 (b) "Practice as a licensed pharmacy technician" does not include:
304 (i) performing a drug utilization review, prescription drug order clarification from a
305 prescriber, final review of the prescription and prescribed drug prepared for dispensing,
306 dispensing of the drug, or counseling a patient with respect to a prescription drug;
307 (ii) counseling regarding nonprescription drugs and dietary supplements unless
308 delegated by the supervising pharmacist; or
309 (iii) receiving new prescription drug orders when communicating telephonically or
310 electronically unless the original information is recorded so the pharmacist may review the
311 prescription drug order as transmitted.
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313 (a) providing pharmaceutical care;
314 (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
315 practice agreement;
316 (c) compounding, packaging, labeling, dispensing, administering, and the coincident
317 distribution of prescription drugs or devices, provided that the administration of a prescription
318 drug or device is:
319 (i) pursuant to a lawful order of a practitioner when one is required by law; and
320 (ii) in accordance with written guidelines or protocols:
321 (A) established by the licensed facility in which the prescription drug or device is to be
322 administered on an inpatient basis; or
323 (B) approved by the division, in collaboration with the board and the Physicians
324 Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
325 administered on an outpatient basis solely by a licensed pharmacist;
326 (d) participating in drug utilization review;
327 (e) ensuring proper and safe storage of drugs and devices;
328 (f) maintaining records of drugs and devices in accordance with state and federal law
329 and the standards and ethics of the profession;
330 (g) providing information on drugs or devices, which may include advice relating to
331 therapeutic values, potential hazards, and uses;
332 (h) providing drug product equivalents;
333 (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
334 technicians;
335 (j) providing patient counseling, including adverse and therapeutic effects of drugs;
336 (k) providing emergency refills as defined by rule;
337 (l) telepharmacy; and
338 (m) formulary management intervention.
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340 of telecommunications and information technologies.
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342 pharmacy through the use of telecommunications and information technologies that occurs
343 when the patient is physically located within one jurisdiction and the pharmacist is located in
344 another jurisdiction.
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346 otherwise authorized by the appropriate jurisdiction to prescribe and administer drugs in the
347 course of professional practice.
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349 (a) orally or in writing; or
350 (b) by telephone, facsimile transmission, computer, or other electronic means of
351 communication as defined by division rule.
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353 (a) by a licensed practitioner in the course of that practitioner's professional practice or
354 by collaborative pharmacy practice agreement; and
355 (b) for a controlled substance or other prescription drug or device for use by a patient
356 or an animal.
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358 contrivance, implant, in vitro reagent, or other similar or related article, and any component
359 part or accessory, which is required under federal or state law to be prescribed by a practitioner
360 and dispensed by or through a person or entity licensed under this chapter or exempt from
361 licensure under this chapter.
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363 rule to be dispensed only by prescription or is restricted to administration only by practitioners.
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365 drugs and devices to the general public.
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367 compliance with this chapter.
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369 operation of the pharmacy during a given day or shift.
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371 (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
372 pharmacy technician in nonjudgmental duties not included in the definition of the practice of
373 pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
374 those duties may be further defined by division rule adopted in collaboration with the board;
375 and
376 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
377 collaboration with the board.
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380 58-17b-502 and may be further defined by rule.
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382 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
383 for animals.
384 Section 2. Section 58-17b-303.5 is enacted to read:
385 58-17b-303.5. Qualifications for licensure as a dispensing medical practitioner.
386 An applicant for licensure as a dispensing medical practitioner shall:
387 (1) submit an application in a form prescribed by the division;
388 (2) pay a fee as determined by the department under Section 63J-1-504 ;
389 (3) produce satisfactory evidence of good moral character as it relates to the applicant's
390 ability to practice pharmacy;
391 (4) complete a criminal background check and be free from criminal convictions as
392 described in Section 58-1-501 ;
393 (5) have no physical or mental condition of a nature that prevents the applicant from
394 engaging in the practice of pharmacy with reasonable skill, competency, and safety to the
395 public;
396 (6) meet the preliminary educational qualifications required by division rule and in
397 collaboration with the board; and
398 (7) have successfully passed examinations required by division rule made in
399 collaboration with the board.
400 Section 3. Section 58-17b-612 is amended to read:
401 58-17b-612. Supervision -- Pharmacist-in-charge.
402 (1) (a) Any pharmacy, except a wholesaler, distributor, out-of-state mail service
403 pharmacy, or class E pharmacy, shall be under the general supervision of at least one
404 pharmacist licensed to practice in Utah. One pharmacist licensed in Utah shall be designated
405 as the pharmacist-in-charge, whose responsibility it is to oversee the operation of the pharmacy.
406 (b) Notwithstanding Subsection 58-17b-102 [
407 not have to be in the pharmacy or care facility but shall be available via a telepharmacy system
408 for immediate contact with the supervised pharmacy technician or pharmacy intern if:
409 (i) the pharmacy is located in:
410 (A) a remote rural hospital, as defined in Section 26-21-13.6 ; or
411 (B) a clinic located in a remote rural county with less than 20 people per square mile;
412 (ii) the supervising pharmacist described in Subsection (1)(a) is not available; and
413 (iii) the telepharmacy system maintains records and files quarterly reports as required
414 by division rule to assure that patient safety is not compromised.
415 (2) Each out-of-state mail service pharmacy shall designate and identify to the division
416 a pharmacist holding a current license in good standing issued by the state in which the
417 pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
418 chapter.
Legislative Review Note
as of 3-1-13 7:28 PM