1     
PHARMACY PRACTICE REVISIONS

2     
2021 GENERAL SESSION

3     
STATE OF UTAH

4     
Chief Sponsor: Evan J. Vickers

5     
House Sponsor: Paul Ray

6     

7     LONG TITLE
8     General Description:
9          This bill amends provisions related to pharmacy.
10     Highlighted Provisions:
11          This bill:
12          ▸     amends definitions;
13          ▸     amends requirements for licensure as a pharmacy technician trainee;
14          ▸     amends provisions governing the dispensing of opiate medication assisted treatment
15     at an opioid treatment program;
16          ▸     amends provisions governing the audit of pharmacy records by or on behalf of an
17     entity that finances or reimburses the cost of health care services or pharmaceutical
18     products;
19          ▸     amends provisions governing the administration of injectables by pharmacists;
20          ▸     addresses corrections to data submitted to the controlled substance database; and
21          ▸     makes technical changes.
22     Money Appropriated in this Bill:
23          None
24     Other Special Clauses:
25          None
26     Utah Code Sections Affected:
27     AMENDS:
28          49-20-502, as enacted by Laws of Utah 2011, Chapter 83
29          58-17b-102, as last amended by Laws of Utah 2019, Chapter 343

30          58-17b-305.1, as last amended by Laws of Utah 2020, Chapter 339
31          58-17b-309.7, as enacted by Laws of Utah 2019, Chapter 311
32          58-17b-610, as last amended by Laws of Utah 2012, Chapter 320
33          58-17b-622, as last amended by Laws of Utah 2018, Chapter 39
34          58-17b-625, as last amended by Laws of Utah 2019, Chapter 343
35          58-37f-203, as last amended by Laws of Utah 2020, Chapters 147, 339, and 372
36          58-37f-303, as last amended by Laws of Utah 2020, Chapters 147 and 339
37     

38     Be it enacted by the Legislature of the state of Utah:
39          Section 1. Section 49-20-502 is amended to read:
40          49-20-502. Definitions.
41          As used in this part:
42          (1) "Health benefit plan" means:
43          (a) a health benefit plan as defined in Section 31A-1-301; or
44          (b) a health, dental, medical, Medicare supplement, or conversion program offered
45     under Title 49, Chapter 20, Public Employees' Benefit and Insurance Program Act.
46          (2) "Pharmacist" is as defined in Section 58-17b-102.
47          (3) "Pharmacy" is as defined in Section 58-17b-102.
48          (4) "Pharmacy benefits management service" means [any of the following services
49     provided to a health benefit plan, or to a participant of the health benefit plan:] the same as that
50     term is defined in Section 31A-46-102.
51          [(a) negotiating the amount to be paid by a health benefit plan for a prescription drug;
52     or]
53          [(b) administering or managing prescription drug benefits provided by the health
54     benefit plan for the benefit of a participant of the health benefit plan, including:]
55          [(i) mail service pharmacy;]
56          [(ii) specialty pharmacy;]
57          [(iii) claims processing;]

58          [(iv) payment of a claim;]
59          [(v) retail network management;]
60          [(vi) clinical formulary development;]
61          [(vii) clinical formulary management services;]
62          [(viii) rebate contracting;]
63          [(ix) rebate administration;]
64          [(x) a participant compliance program;]
65          [(xi) a therapeutic intervention program;]
66          [(xii) a disease management program; or]
67          [(xiii) a service that is similar to, or related to, a service described in Subsection (4)(a)
68     or (4)(b)(i) through (xii).]
69          (5) "Pharmacy benefits manager" means a person that provides a pharmacy benefits
70     management service to [a health benefit plan] the program.
71          (6) "Pharmacy service" means a product, good, or service provided by a pharmacy or
72     pharmacist to an individual.
73          Section 2. 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. Sec. 351 (2003).

86          (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
87     the purpose of analysis.
88          (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
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
119     setting; and
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 that engages in the manufacture,
125     production, wholesale, or distribution of drugs or devices in Utah.
126          (13) "Class D pharmacy" means a nonresident pharmacy.
127          (14) "Class E pharmacy" means all other pharmacies.
128          (15) (a) "Closed-door pharmacy" means a pharmacy that:
129          (i) provides pharmaceutical care to a defined and exclusive group of patients who have
130     access to the services of the pharmacy because they are treated by or have an affiliation with a
131     specific entity, including a health maintenance organization or an infusion company; or
132          (ii) engages exclusively in the practice of telepharmacy and does not serve walk-in
133     retail customers.
134          (b) "Closed-door pharmacy" does not include a hospital pharmacy, a retailer of goods
135     to the general public, or the office of a practitioner.
136          (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
137     more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
138     more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
139     care functions authorized by the practitioner or practitioners under certain specified conditions
140     or limitations.
141          (17) "Collaborative pharmacy practice agreement" means a written and signed

142     agreement between one or more pharmacists and one or more practitioners that provides for
143     collaborative pharmacy practice for the purpose of drug therapy management of patients and
144     prevention of disease of human subjects.
145          (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
146     labeling of a limited quantity drug, sterile product, or device:
147          (i) as the result of a practitioner's prescription order or initiative based on the
148     practitioner, patient, or pharmacist relationship in the course of professional practice;
149          (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
150     not for sale or dispensing; or
151          (iii) in anticipation of prescription drug orders based on routine, regularly observed
152     prescribing patterns.
153          (b) "Compounding" does not include:
154          (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
155     another pharmacist or pharmaceutical facility;
156          (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
157     dosage form which is regularly and commonly available from a manufacturer in quantities and
158     strengths prescribed by a practitioner; or
159          (iii) the preparation of a prescription drug, sterile product, or device which has been
160     withdrawn from the market for safety reasons.
161          (19) "Confidential information" has the same meaning as "protected health
162     information" under the Standards for Privacy of Individually Identifiable Health Information,
163     45 C.F.R. Parts 160 and 164.
164          (20) "Controlled substance" means the same as that term is defined in Section 58-37-2.
165          (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
166     417, Sec. 3a(ff) which is incorporated by reference.
167          (22) "Dispense" means the interpretation, evaluation, and implementation of a
168     prescription drug order or device or nonprescription drug or device under a lawful order of a
169     practitioner in a suitable container appropriately labeled for subsequent administration to or use

170     by a patient, research subject, or an animal.
171          (23) "Dispensing medical practitioner" means an individual who is:
172          (a) currently licensed as:
173          (i) a physician and surgeon under Chapter 67, Utah Medical Practice Act;
174          (ii) an osteopathic physician and surgeon under Chapter 68, Utah Osteopathic Medical
175     Practice Act;
176          (iii) a physician assistant under Chapter 70a, Utah Physician Assistant Act;
177          (iv) a nurse practitioner under Chapter 31b, Nurse Practice Act; or
178          (v) an optometrist under Chapter 16a, Utah Optometry Practice Act, if the optometrist
179     is acting within the scope of practice for an optometrist; and
180          (b) licensed by the division under the Pharmacy Practice Act to engage in the practice
181     of a dispensing medical practitioner.
182          (24) "Dispensing medical practitioner clinic pharmacy" means a closed-door pharmacy
183     located within a licensed dispensing medical practitioner's place of practice.
184          (25) "Distribute" means to deliver a drug or device other than by administering or
185     dispensing.
186          (26) (a) "Drug" means:
187          (i) a substance recognized in the official United States Pharmacopoeia, official
188     Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any
189     supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
190     prevention of disease in humans or animals;
191          (ii) a substance that is required by any applicable federal or state law or rule to be
192     dispensed by prescription only or is restricted to administration by practitioners only;
193          (iii) a substance other than food intended to affect the structure or any function of the
194     body of humans or other animals; and
195          (iv) substances intended for use as a component of any substance specified in
196     Subsections (26)(a)(i), (ii), (iii), and (iv).
197          (b) "Drug" does not include dietary supplements.

198          (27) "Drug regimen review" includes the following activities:
199          (a) evaluation of the prescription drug order and patient record for:
200          (i) known allergies;
201          (ii) rational therapy-contraindications;
202          (iii) reasonable dose and route of administration; and
203          (iv) reasonable directions for use;
204          (b) evaluation of the prescription drug order and patient record for duplication of
205     therapy;
206          (c) evaluation of the prescription drug order and patient record for the following
207     interactions:
208          (i) drug-drug;
209          (ii) drug-food;
210          (iii) drug-disease; and
211          (iv) adverse drug reactions; and
212          (d) evaluation of the prescription drug order and patient record for proper utilization,
213     including over- or under-utilization, and optimum therapeutic outcomes.
214          (28) "Drug sample" means a prescription drug packaged in small quantities consistent
215     with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
216     be sold, and is intended to be provided to practitioners for the immediate needs of patients for
217     trial purposes or to provide the drug to the patient until a prescription can be filled by the
218     patient.
219          (29) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
220     symbol, or process attached to or logically associated with a record and executed or adopted by
221     a person with the intent to sign the record.
222          (30) "Electronic transmission" means transmission of information in electronic form or
223     the transmission of the exact visual image of a document by way of electronic equipment.
224          (31) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
225     inpatients of a general acute hospital or specialty hospital licensed by the Department of Health

226     under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
227          (32) "Legend drug" has the same meaning as prescription drug.
228          (33) "Licensed pharmacy technician" means an individual licensed with the division,
229     that may, under the supervision of a pharmacist, perform the activities involved in the
230     technician practice of pharmacy.
231          (34) "Manufacturer" means a person or business physically located in Utah licensed to
232     be engaged in the manufacturing of drugs or devices.
233          (35) (a) "Manufacturing" means:
234          (i) the production, preparation, propagation, conversion, or processing of a drug or
235     device, either directly or indirectly, by extraction from substances of natural origin or
236     independently by means of chemical or biological synthesis, or by a combination of extraction
237     and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
238     or relabeling of its container; and
239          (ii) the promotion and marketing of such drugs or devices.
240          (b) "Manufacturing" includes the preparation and promotion of commercially available
241     products from bulk compounds for resale by pharmacies, practitioners, or other persons.
242          (c) "Manufacturing" does not include the preparation or compounding of a drug by a
243     pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
244     compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
245     analysis.
246          (36) "Medical order" means a lawful order of a practitioner which may include a
247     prescription drug order.
248          (37) "Medication profile" or "profile" means a record system maintained as to drugs or
249     devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
250     the profile to provide pharmaceutical care.
251          (38) "Misbranded drug or device" means a drug or device considered misbranded under
252     21 U.S.C. Sec. 352 (2003).
253          (39) (a) "Nonprescription drug" means a drug which:

254          (i) may be sold without a prescription; and
255          (ii) is labeled for use by the consumer in accordance with federal law.
256          (b) "Nonprescription drug" includes homeopathic remedies.
257          (40) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
258     person in Utah.
259          (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
260          (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
261     outside the state that is licensed and in good standing in another state, that:
262          (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
263     this state pursuant to a lawfully issued prescription;
264          (b) provides information to a patient in this state on drugs or devices which may
265     include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
266     or
267          (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
268     effects of drugs.
269          (43) "Patient counseling" means the written and oral communication by the pharmacist
270     or pharmacy intern of information, to the patient or caregiver, in order to ensure proper use of
271     drugs, devices, and dietary supplements.
272          (44) "Pharmaceutical administration facility" means a facility, agency, or institution in
273     which:
274          (a) prescription drugs or devices are held, stored, or are otherwise under the control of
275     the facility or agency for administration to patients of that facility or agency;
276          (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
277     or pharmacy intern with whom the facility has established a prescription drug supervising
278     relationship under which the pharmacist or pharmacy intern provides counseling to the facility
279     or agency staff as required, and oversees drug control, accounting, and destruction; and
280          (c) prescription drugs are professionally administered in accordance with the order of a
281     practitioner by an employee or agent of the facility or agency.

282          (45) (a) "Pharmaceutical care" means carrying out the following in collaboration with a
283     prescribing practitioner, and in accordance with division rule:
284          (i) designing, implementing, and monitoring a therapeutic drug plan intended to
285     achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
286     the patient's disease;
287          (ii) eliminating or reducing a patient's symptoms; or
288          (iii) arresting or slowing a disease process.
289          (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
290     prescribing practitioner.
291          (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
292     distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
293     state.
294          (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
295     engaged in the business of wholesale vending or selling of a prescription drug or device to
296     other than a consumer or user of the prescription drug or device that the pharmaceutical facility
297     has not produced, manufactured, compounded, or dispensed.
298          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
299     facility carrying out the following business activities:
300          (i) intracompany sales;
301          (ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
302     purchase, or trade a prescription drug or device, if the activity is carried out between one or
303     more of the following entities under common ownership or common administrative control, as
304     defined by division rule:
305          (A) hospitals;
306          (B) pharmacies;
307          (C) chain pharmacy warehouses, as defined by division rule; or
308          (D) other health care entities, as defined by division rule;
309          (iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,

310     purchase, or trade a prescription drug or device, for emergency medical reasons, including
311     supplying another pharmaceutical facility with a limited quantity of a drug, if:
312          (A) the facility is unable to obtain the drug through a normal distribution channel in
313     sufficient time to eliminate the risk of harm to a patient that would result from a delay in
314     obtaining the drug; and
315          (B) the quantity of the drug does not exceed an amount reasonably required for
316     immediate dispensing to eliminate the risk of harm;
317          (iv) the distribution of a prescription drug or device as a sample by representatives of a
318     manufacturer; and
319          (v) the distribution of prescription drugs, if:
320          (A) the facility's total distribution-related sales of prescription drugs does not exceed
321     5% of the facility's total prescription drug sales; and
322          (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
323          (48) "Pharmacist" means an individual licensed by this state to engage in the practice
324     of pharmacy.
325          (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing
326     who accepts responsibility for the operation of a pharmacy in conformance with all laws and
327     rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
328     in full and actual charge of the pharmacy and all personnel.
329          (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with one or
330     more years of licensed experience. The preceptor serves as a teacher, example of professional
331     conduct, and supervisor of interns in the professional practice of pharmacy.
332          (51) "Pharmacy" means any place where:
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
336          (d) drugs are used for the purpose of analysis or research.
337          (52) "Pharmacy benefits manager or coordinator" means a person or entity that

338     provides a pharmacy benefits management service as defined in Section [49-20-502]
339     31A-46-102 on behalf of a self-insured employer, insurance company, health maintenance
340     organization, or other plan sponsor, as defined by rule.
341          (53) "Pharmacy intern" means an individual licensed by this state to engage in practice
342     as a pharmacy intern.
343          (54) "Pharmacy technician training program" means an approved technician training
344     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.
355          (56) "Practice as a licensed pharmacy technician" means engaging in practice as a
356     pharmacy technician under the general supervision of a licensed pharmacist and in accordance
357     with a scope of practice defined by division rule made in collaboration with the board.
358          (57) "Practice of pharmacy" includes the following:
359          (a) providing pharmaceutical care;
360          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
361     practice agreement;
362          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
363     distribution of prescription drugs or devices, provided that the administration of a prescription
364     drug or device is:
365          (i) pursuant to a lawful order of a practitioner when one is required by law; and

366          (ii) in accordance with written guidelines or protocols:
367          (A) established by the licensed facility in which the prescription drug or device is to be
368     administered on an inpatient basis; or
369          (B) approved by the division, in collaboration with the board and, when appropriate,
370     the Physicians Licensing Board, created in Section 58-67-201, if the prescription drug or device
371     is to be administered on an outpatient basis solely by a licensed pharmacist;
372          (d) participating in drug utilization review;
373          (e) ensuring proper and safe storage of drugs and devices;
374          (f) maintaining records of drugs and devices in accordance with state and federal law
375     and the standards and ethics of the profession;
376          (g) providing information on drugs or devices, which may include advice relating to
377     therapeutic values, potential hazards, and uses;
378          (h) providing drug product equivalents;
379          (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
380     technicians;
381          (j) providing patient counseling, including adverse and therapeutic effects of drugs;
382          (k) providing emergency refills as defined by rule;
383          (l) telepharmacy;
384          (m) formulary management intervention; and
385          (n) prescribing and dispensing a self-administered hormonal contraceptive in
386     accordance with Title 26, Chapter 64, Family Planning Access Act.
387          (58) "Practice of telepharmacy" means the practice of pharmacy through the use of
388     telecommunications and information technologies.
389          (59) "Practice of telepharmacy across state lines" means the practice of pharmacy
390     through the use of telecommunications and information technologies that occurs when the
391     patient is physically located within one jurisdiction and the pharmacist is located in another
392     jurisdiction.
393          (60) "Practitioner" means an individual currently licensed, registered, or otherwise

394     authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of
395     professional practice.
396          (61) "Prescribe" means to issue a prescription:
397          (a) orally or in writing; or
398          (b) by telephone, facsimile transmission, computer, or other electronic means of
399     communication as defined by division rule.
400          (62) "Prescription" means an order issued:
401          (a) by a licensed practitioner in the course of that practitioner's professional practice or
402     by collaborative pharmacy practice agreement; and
403          (b) for a controlled substance or other prescription drug or device for use by a patient
404     or an animal.
405          (63) "Prescription device" means an instrument, apparatus, implement, machine,
406     contrivance, implant, in vitro reagent, or other similar or related article, and any component
407     part or accessory, which is required under federal or state law to be prescribed by a practitioner
408     and dispensed by or through a person or entity licensed under this chapter or exempt from
409     licensure under this chapter.
410          (64) "Prescription drug" means a drug that is required by federal or state law or rule to
411     be dispensed only by prescription or is restricted to administration only by practitioners.
412          (65) "Repackage":
413          (a) means changing the container, wrapper, or labeling to further the distribution of a
414     prescription drug; and
415          (b) does not include:
416          (i) Subsection (65)(a) when completed by the pharmacist responsible for dispensing the
417     product to a patient; or
418          (ii) changing or altering a label as necessary for a dispensing practitioner under Part 8,
419     Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, for
420     dispensing a product to a patient.
421          (66) "Research using pharmaceuticals" means research:

422          (a) conducted in a research facility, as defined by division rule, that is associated with a
423     university or college in the state accredited by the Northwest Commission on Colleges and
424     Universities;
425          (b) requiring the use of a controlled substance, prescription drug, or prescription
426     device;
427          (c) that uses the controlled substance, prescription drug, or prescription device in
428     accordance with standard research protocols and techniques, including, if required, those
429     approved by an institutional review committee; and
430          (d) that includes any documentation required for the conduct of the research and the
431     handling of the controlled substance, prescription drug, or prescription device.
432          (67) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugs
433     and devices to the general public.
434          (68) (a) "Self-administered hormonal contraceptive" means a self-administered
435     hormonal contraceptive that is approved by the United States Food and Drug Administration to
436     prevent pregnancy.
437          (b) "Self-administered hormonal contraceptive" includes an oral hormonal
438     contraceptive, a hormonal vaginal ring, and a hormonal contraceptive patch.
439          (c) "Self-administered hormonal contraceptive" does not include any drug intended to
440     induce an abortion, as that term is defined in Section 76-7-301.
441          (69) "Self-audit" means an internal evaluation of a pharmacy to determine compliance
442     with this chapter.
443          (70) "Supervising pharmacist" means a pharmacist who is overseeing the operation of
444     the pharmacy during a given day or shift.
445          (71) "Supportive personnel" means unlicensed individuals who:
446          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
447     pharmacy technician in nonjudgmental duties not included in the definition of the practice of
448     pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
449     those duties may be further defined by division rule adopted in collaboration with the board;

450     and
451          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
452     collaboration with the board.
453          (72) "Unlawful conduct" means the same as that term is defined in Sections 58-1-501
454     and 58-17b-501.
455          (73) "Unprofessional conduct" means the same as that term is defined in Sections
456     58-1-501 and 58-17b-502 and may be further defined by rule.
457          (74) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
458     dispenses drugs intended for use by animals or for sale to veterinarians for the administration
459     for animals.
460          Section 3. Section 58-17b-305.1 is amended to read:
461          58-17b-305.1. Qualifications for licensure of pharmacy technician trainee.
462          (1) An applicant for licensure as a pharmacy technician trainee shall:
463          (a) submit an application to the division on a form created by the division;
464          (b) pay a fee established by the division in accordance with Section 63J-1-504;
465          (c) unless exempted by the division, submit a completed criminal background check;
466          (d) demonstrate, as determined by the division, that the applicant does not have a
467     physical or mental condition that would prevent the applicant from engaging in practice as a
468     pharmacy technician with reasonable skill, competency, and safety to the public; [and]
469          (e) submit evidence that the applicant is enrolled in a training program approved by the
470     division[.]; and
471          (f) satisfy any other criteria established by division rule made in collaboration with the
472     board.
473          (2) A pharmacist whose license has been denied, revoked, suspended, or restricted for
474     disciplinary purposes is not eligible to be licensed as a pharmacy technician trainee during
475     division probation.
476          Section 4. Section 58-17b-309.7 is amended to read:
477          58-17b-309.7. Opioid treatment program.

478          (1) As used in this section:
479          [(a) "Dispense" means to prepare, package, or label for subsequent use.]
480          [(b) "Nurse practitioner" means an individual who is licensed to practice as an
481     advanced practice registered nurse under Chapter 31b, Nurse Practice Act.]
482          (a) "Covered provider" means an individual who is licensed to engage in:
483          (i) the practice of advanced practice registered nursing as defined in Section
484     58-31b-102;
485          (ii) the practice of registered nursing as defined in Section 58-31b-102; or
486          (iii) practice as a physician assistant as defined in Section 58-70a-102.
487          [(c)] (b) "Opioid treatment program" means a program or practitioner that is:
488          (i) engaged in [opioid treatment of an individual using] dispensing an opiate [agonist]
489     medication assisted treatment for opioid use disorder;
490          (ii) registered under 21 U.S.C. Sec. 823(g)(1);
491          (iii) licensed by the Office of Licensing[,] within the Department of Human Services[,]
492     created in Section 62A-2-103; and
493          (iv) certified by the Substance Abuse and Mental Health Services Administration in
494     accordance with 42 C.F.R. 8.11.
495          [(d) "Physician" means an individual licensed to practice as a physician or osteopath in
496     this state under Chapter 67, Utah Medical Practice Act, or Chapter 68, Utah Osteopathic
497     Medical Practice Act.]
498          [(e) "Physician assistant" means an individual who is licensed to practice as a physician
499     assistant under Chapter 70a, Utah Physician Assistant Act.]
500          [(f) "Practitioner" means a nurse practitioner, physician's assistant, or a registered
501     nurse.]
502          [(g) "Registered nurse" means the same as that term is defined in Section 78B-3-403.]
503          (2) A [practitioner] covered provider may dispense [methadone] opiate medication
504     assisted treatment at an opioid treatment program [regardless of whether the practitioner is
505     licensed to dispense methadone under this chapter if the practitioner] if the covered provider:

506          (a) is operating under the direction of a pharmacist;
507          (b) dispenses the [methadone] opiate medication assisted treatment under the direction
508     of a pharmacist; and
509          (c) acts in accordance with division rule made under Subsection (3).
510          (3) The division shall, in consultation with [pharmacies, physicians, and] practitioners
511     who work in an opioid treatment program, make rules in accordance with Title 63G, Chapter 3,
512     Utah Administrative Rulemaking Act, to establish guidelines under which a [practitioner]
513     covered provider may dispense [methadone] opiate medication assisted treatment to a patient in
514     an opioid treatment program under this section.
515          Section 5. Section 58-17b-610 is amended to read:
516          58-17b-610. Patients' immediate needs -- Dispensing drug samples.
517          (1) This chapter may not be construed to prevent the personal administration of drugs
518     or medicines by practitioners licensed to prescribe in order to supply the immediate needs of
519     the practitioner's patients.
520          (2) Immediate need for a patient includes giving out drug samples that:
521          (a) are not Schedule II drugs, [opiods, or Benzodiazepines] opioids, or
522     benzodiazepines;
523          (b) are prepackaged by the original manufacturer;
524          (c) are provided to the prescribing practitioner free of charge and provided to the
525     patient free of any direct or indirect charge;
526          (d) do not exceed a 30-day supply for:
527          (i) controlled substances; or
528          (ii) non-controlled substances, unless a prescribing practitioner documents that
529     providing more than a 30-day supply is medically necessary; and
530          (e) (i) are marked on the immediate container to indicate that the drug is a sample; or
531          (ii) are recorded in the patient's chart with the name and number of samples provided.
532          (3) A prescribing practitioner who provides samples for a patient shall comply with
533     Subsection (2).

534          Section 6. Section 58-17b-622 is amended to read:
535          58-17b-622. Pharmacy benefit management services -- Auditing of pharmacy
536     records -- Appeals.
537          (1) For purposes of this section:
538          (a) "Audit" means a review of the records of a pharmacy by or on behalf of an entity
539     that finances or reimburses the cost of health care services or pharmaceutical products.
540          (b) "Audit completion date" means:
541          (i) for an audit that does not require an on-site visit at the pharmacy, the date on which
542     the pharmacy, in response to the initial audit request, submits records or other documents to the
543     entity conducting the audit, as determined by:
544          (A) postmark or other evidence of the date of mailing; or
545          (B) the date of transmission if the records or other documents are transmitted
546     electronically; and
547          (ii) for an audit that requires an on-site visit at a pharmacy, the date on which the
548     auditing entity completes the on-site visit, including any follow-up visits or analysis which
549     shall be completed within 60 days after the day on which the on-site visit begins.
550          [(b)] (c) "Entity" includes:
551          (i) a pharmacy benefits manager or coordinator;
552          (ii) a health benefit plan;
553          (iii) a third party administrator as defined in Section 31A-1-301;
554          (iv) a state agency; or
555          (v) a company, group, or agent that represents, or is engaged by, one of the entities
556     described in Subsections (1)[(b)](c)(i) through (iv).
557          [(c)] (d) "Fraud" means an intentional act of deception, misrepresentation, or
558     concealment in order to gain something of value.
559          [(d)] (e) "Health benefit plan" means:
560          (i) a health benefit plan as defined in Section 31A-1-301; or
561          (ii) a health, dental, medical, Medicare supplement, or conversion program offered

562     under Title 49, Chapter 20, Public Employees' Benefit and Insurance Program Act.
563          (2) (a) Except as provided in Subsection (2)(b), this section applies to:
564          (i) a contract for the audit of a pharmacy entered into, amended, or renewed on or after
565     July 1, 2012; and
566          (ii) an entity that conducts an audit of the pharmacy records of a pharmacy licensed
567     under this chapter.
568          (b) This section does not apply to an audit of pharmacy records:
569          (i) for a federally funded prescription drug program, including:
570          (A) the state Medicaid program;
571          (B) the Medicare Part D program;
572          (C) a Department of Defense prescription drug program; and
573          (D) a Veterans Affairs prescription drug program; or
574          (ii) when fraud or other intentional and willful misrepresentation is alleged and the
575     pharmacy audit entity has evidence that the pharmacy's actions reasonably indicate fraud or
576     intentional and willful misrepresentation.
577          (3) (a) An audit that involves clinical or professional judgment shall be conducted by
578     or in consultation with a pharmacist who is employed by or working with the auditing entity
579     and who is licensed in the state or another state.
580          (b) If an audit is conducted on site at a pharmacy, the entity conducting the audit:
581          (i) shall give the pharmacy 10 days advanced written notice of:
582          (A) the audit; and
583          (B) the range of prescription numbers or a date range included in the audit; and
584          (ii) may not audit a pharmacy during the first five business days of the month, unless
585     the pharmacy agrees to the timing of the audit.
586          (c) An entity may not audit claims:
587          (i) submitted more than 18 months prior to the audit, unless:
588          (A) required by federal law; or
589          (B) the originating prescription is dated in the preceding six months; or

590          (ii) that exceed 200 selected prescription claims.
591          (4) (a) An entity may not:
592          (i) include dispensing fees in the calculations of overpayments unless the prescription
593     is considered a misfill;
594          (ii) recoup funds for prescription clerical or recordkeeping errors, including
595     typographical errors, scrivener's errors, and computer errors on a required document or record
596     unless the audit entity is alleging fraud or other intentional or willful misrepresentation and the
597     audit entity has evidence that the pharmacy's actions reasonably indicate fraud or intentional
598     and willful misrepresentation;
599          (iii) recoup funds for refills dispensed in accordance with Section 58-17b-608.1, unless
600     the health benefit plan does not cover the prescription drug dispensed by the pharmacy; [or]
601          (iv) collect any funds, charge-backs, or penalties until the audit and all appeals are
602     final, unless the audit entity is alleging fraud or other intentional or willful misrepresentation
603     and the audit entity has evidence that the pharmacy's actions reasonably indicate fraud or
604     intentional and willful misrepresentation[.]; or
605          (v) recoup funds or collect any funds, charge-backs, or penalties from a pharmacy in
606     response to a request for audit unless the pharmacy confirms to the entity the date on which the
607     pharmacy received the request for audit.
608          (b) Auditors shall only have access to previous audit reports on a particular pharmacy
609     if the previous audit was conducted by the same entity except as required for compliance with
610     state or federal law.
611          (5) A pharmacy subject to an audit:
612          (a) may use one or more of the following [records] to validate a claim for a
613     prescription, refill, or change in a prescription:
614          [(a)] (i) electronic or physical copies of records of a health care facility, or a health care
615     provider with prescribing authority; [and]
616          [(b)] (ii) any prescription that complies with state law[.];
617          (iii) the pharmacy's own physical or electronic records; or

618          (iv) the physical or electronic records, or valid copies of the physical or electronic
619     records, of a practitioner or health care facility as defined in Section 26-21-2; and
620          (b) may not be required to provide the following records to validate a claim for a
621     prescription, refill, or change in a prescription:
622          (i) if the prescription was handwritten, the physical handwritten version of the
623     prescription; or
624          (ii) a note from the practitioner regarding the patient or the prescription that is not
625     otherwise required for a prescription under state or federal law.
626          (6) (a) (i) An entity that audits a pharmacy shall establish:
627          (A) a maximum time for the pharmacy to submit records or other documents to the
628     entity following receipt of an audit request for records or documents; and
629          (B) a maximum time for the entity to provide the pharmacy with a preliminary audit
630     report following submission of records under Subsection (6)(a)(i)(A).
631          (ii) The time limits established under Subsections (6)(a)(i)(A) and (B):
632          (A) shall be identical; and
633          (B) may not be less than seven days or more than 60 days.
634          (iii) An entity that audits a pharmacy may not, after the audit completion date, request
635     additional records or other documents from the pharmacy to complete the preliminary audit
636     report described in Subsection (6)(b).
637          [(6) (a)] (b) An entity that audits a pharmacy shall provide the pharmacy with a
638     preliminary audit report, delivered to the pharmacy or its corporate office of record, within [60
639     days after completion of the audit] the time limit established under Subsection (6)(a)(i)(B).
640          [(b)] (c) (i) [A] Except as provided in Subsection (6)(c)(ii), a pharmacy has 30 days
641     following receipt of the preliminary audit report to respond to questions, provide additional
642     documentation, and comment on and clarify findings of the audit.
643          (ii) An entity may grant a reasonable extension under Subsection (6)(c)(i) upon request
644     by the pharmacy.
645          (iii) Receipt of the report under Subsection (6)(c)(i) shall be [based on the] determined

646     by:
647          (A) postmark [date] or other evidence of the date of mailing; or
648          (B) the date of [a computer] transmission if [transferred] the report is transmitted
649     electronically.
650          (iv) If a dispute exists between the records of the auditing entity and the pharmacy, the
651     records maintained by the pharmacy shall be presumed valid for the purpose of the audit.
652          (7) If an audit results in the dispute or denial of a claim, the entity conducting the audit
653     shall allow:
654          (a) the pharmacy to resubmit a claim using any commercially reasonable method,
655     including fax, mail, or electronic claims submission provided that the period of time when a
656     claim may be resubmitted has not expired under the rules of the plan sponsor[.]; and
657          (b) the health benefit plan or other entity that finances or reimburses the cost of health
658     care services or pharmaceutical products to rerun the claim if the health benefit plan or other
659     entity chooses to rerun the claim at no cost to the pharmacy.
660          (8) (a) Within [120] 60 days after the completion of the appeals process under
661     Subsection (9), a final audit report shall be delivered to the pharmacy or its corporate office of
662     record.
663          (b) The final audit report shall include a disclosure of any money recovered by the
664     entity that conducted the audit.
665          (9) (a) An entity that audits a pharmacy shall establish a written appeals process for
666     appealing a preliminary audit report and a final audit report, and shall provide the pharmacy
667     with notice of the written appeals process.
668          (b) If the pharmacy benefit manager's contract or provider manual contains the
669     information required by this Subsection (9), the requirement for notice is met.
670          Section 7. Section 58-17b-625 is amended to read:
671          58-17b-625. Administration of a long-acting injectable and naloxone.
672          (1) A pharmacist may, in accordance with this section, administer a drug described in
673     Subsection (2).

674          (2) Notwithstanding the provisions of Subsection 58-17b-102(57)(c)(ii)(B), the
675     division shall make rules[,] in collaboration with the board and, when appropriate, the
676     Physicians Licensing Board created in Section 58-67-201, and in accordance with Title 63G,
677     Chapter 3, Utah Administrative Rulemaking Act, [establishing] to establish training for a
678     pharmacist to administer [the following] naloxone and long-acting injectables
679     intramuscularly[:].
680          [(a) aripiprazole;]
681          [(b) aripiprazole lauroxil;]
682          [(c) paliperidone;]
683          [(d) risperidone;]
684          [(e) olanzapine;]
685          [(f) naltrexone;]
686          [(g) naloxone; and]
687          [(h) drugs approved and regulated by the United States Food and Drug Administration
688     for the treatment of the Human Immunodeficiency Virus.]
689          (3) A pharmacist may not administer [a drug listed under Subsection (2)] naloxone or a
690     long-acting injectable intramuscularly unless the pharmacist:
691          (a) completes the training described in Subsection (2);
692          (b) administers the drug at a clinic or community pharmacy, as those terms are defined
693     by the division, by administrative rule made in accordance with Title 63G, Chapter 3, Utah
694     Administrative Rulemaking Act; and
695          (c) is directed by the physician, as that term is defined in Section 58-67-102 or Section
696     58-68-102, who issues the prescription to administer the drug.
697          Section 8. Section 58-37f-203 is amended to read:
698          58-37f-203. Submission, collection, and maintenance of data.
699          (1) (a) The division shall implement on a statewide basis, including non-resident
700     pharmacies as defined in Section 58-17b-102, the following two options for a pharmacist to
701     submit information:

702          (i) real-time submission of the information required to be submitted under this part to
703     the controlled substance database; and
704          (ii) 24-hour daily or next business day, whichever is later, batch submission of the
705     information required to be submitted under this part to the controlled substance database.
706          (b) A pharmacist shall comply with either:
707          (i) the submission time requirements established by the division under Subsection
708     (1)(a)(i); or
709          (ii) the submission time requirements established by the division under Subsection
710     (1)(a)(ii).
711          (c) Notwithstanding the time requirements described in Subsection (1)(a), a pharmacist
712     may submit corrections to data that the pharmacist has submitted to the controlled substance
713     database within seven business days after the day on which the division notifies the pharmacist
714     that data is incomplete or corrections to the data are otherwise necessary.
715          [(c)] (d) The division shall comply with Title 63G, Chapter 6a, Utah Procurement
716     Code.
717          (2) (a) The pharmacist-in-charge and the pharmacist of the drug outlet where a
718     controlled substance is dispensed shall submit the data described in this section to the division
719     in accordance with:
720          (i) the requirements of this section;
721          (ii) the procedures established by the division;
722          (iii) additional types of information or data fields established by the division; and
723          (iv) the format established by the division.
724          (b) A dispensing medical practitioner licensed under Chapter 17b, Part 8, Dispensing
725     Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, shall comply with
726     the provisions of this section and the dispensing medical practitioner shall assume the duties of
727     the pharmacist under this chapter.
728          (3) (a) Except as provided in Subsection (3)(b), the pharmacist-in-charge and the
729     pharmacist described in Subsection (2)(a) shall, for each controlled substance dispensed by a

730     pharmacist under the pharmacist's supervision, submit to the division any type of information
731     or data field established by the division by rule in accordance with Subsection (6) regarding:
732          (i) each controlled substance that is dispensed by the pharmacist or under the
733     pharmacist's supervision; and
734          (ii) each noncontrolled substance that is:
735          (A) designated by the division under Subsection (8)(a); and
736          (B) dispensed by the pharmacist or under the pharmacist's supervision.
737          (b) Subsection (3)(a) does not apply to a drug that is dispensed for administration to, or
738     use by, a patient at a health care facility, including a patient in an outpatient setting at the health
739     care facility.
740          (4) An individual whose records are in the database may obtain those records upon
741     submission of a written request to the division.
742          (5) (a) A patient whose record is in the database may contact the division in writing to
743     request correction of any of the patient's database information that is incorrect.
744          (b) The division shall grant or deny the request within 30 days from receipt of the
745     request and shall advise the requesting patient of its decision within 35 days of receipt of the
746     request.
747          (c) If the division denies a request under this Subsection (5) or does not respond within
748     35 days, the patient may submit an appeal to the Department of Commerce, within 60 days
749     after the patient's written request for a correction under this Subsection (5).
750          (6) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
751     Administrative Rulemaking Act, to establish submission requirements under this part,
752     including:
753          (a) electronic format;
754          (b) submission procedures; and
755          (c) required information and data fields.
756          (7) The division shall ensure that the database system records and maintains for
757     reference:

758          (a) the identification of each individual who requests or receives information from the
759     database;
760          (b) the information provided to each individual; and
761          (c) the date and time that the information is requested or provided.
762          (8) (a) The division, in collaboration with the Utah Controlled Substance Advisory
763     Committee created in Section 58-38a-201, shall designate a list of noncontrolled substances
764     described in Subsection (8)(b) by rule made in accordance with Title 63G, Chapter 3, Utah
765     Administrative Rulemaking Act.
766          (b) To determine whether a prescription drug should be designated in the schedules of
767     controlled substances under this chapter, the division may collect information about a
768     prescription drug as defined in Section 58-17b-102 that is not designated in the schedules of
769     controlled substances under this chapter.
770          Section 9. Section 58-37f-303 is amended to read:
771          58-37f-303. Access to opioid prescription information via an electronic data
772     system.
773          (1) As used in this section:
774          (a) "Dispense" means the same as that term is defined in Section 58-17b-102.
775          (b) "EDS user":
776          (i) means:
777          (A) a prescriber;
778          (B) a pharmacist;
779          (C) a pharmacy intern;
780          (D) a pharmacy technician; or
781          (E) an individual granted access to the database under Subsection 58-37f-301(3)(c);
782     and
783          (ii) does not mean an individual whose access to the database has been revoked by the
784     division pursuant to Subsection 58-37f-301(5)(c).
785          (c) "Electronic data system" means a software product or an electronic service used by:

786          (i) a prescriber to manage electronic health records; or
787          (ii) a pharmacist, pharmacy intern, or pharmacy technician working under the general
788     supervision of a licensed pharmacist [to manage], for the purpose of:
789          (A) managing the dispensing of prescription drugs[.]; or
790          (B) providing pharmaceutical care as defined in Section 58-17b-102 to a patient.
791          (d) "Opioid" means any substance listed in Subsection 58-37-4(2)(b)(i) or (2)(b)(ii).
792          (e) "Pharmacist" means the same as that term is defined in Section 58-17b-102.
793          (f) "Prescriber" means a practitioner, as that term is defined in Section 58-37-2, who is
794     licensed under Section 58-37-6 to prescribe an opioid.
795          (g) "Prescription drug" means the same as that term is defined in Section 58-17b-102.
796          (2) Subject to Subsections (3) through (6), no later than January 1, 2017, the division
797     shall make opioid prescription information in the database available to an EDS user via the
798     user's electronic data system.
799          (3) An electronic data system may be used to make opioid prescription information in
800     the database available to an EDS user only if the electronic data system complies with rules
801     established by the division under Subsection (4).
802          (4) (a) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
803     Administrative Rulemaking Act, specifying:
804          (i) an electronic data system's:
805          (A) allowable access to and use of opioid prescription information in the database; and
806          (B) minimum actions that must be taken to ensure that opioid prescription information
807     accessed from the database is protected from inappropriate disclosure or use; and
808          (ii) an EDS user's:
809          (A) allowable access to opioid prescription information in the database via an
810     electronic data system; and
811          (B) allowable use of the information.
812          (b) The rules shall establish:
813          (i) minimum user identification requirements that in substance are the same as the

814     database identification requirements in Section 58-37f-301;
815          (ii) user access restrictions that in substance are the same as the database identification
816     requirements in Section 58-37f-301; and
817          (iii) any other requirements necessary to ensure that in substance the provisions of
818     Sections 58-37f-301 and 58-37f-302 apply to opioid prescription information in the database
819     that has been made available to an EDS user via an electronic data system.
820          (5) The division may not make opioid prescription information in the database
821     available to an EDS user via the user's electronic data system if:
822          (a) the electronic data system does not comply with the rules established by the
823     division under Subsection (4); or
824          (b) the EDS user does not comply with the rules established by the division under
825     Subsection (4).
826          (6) (a) The division shall periodically audit the use of opioid prescription information
827     made available to an EDS user via the user's electronic data system.
828          (b) The audit shall review compliance by:
829          (i) the electronic data system with rules established by the division under Subsection
830     (4); and
831          (ii) the EDS user with rules established by the division under Subsection (4).
832          (c) (i) If the division determines by audit or other means that an electronic data system
833     is not in compliance with rules established by the division under Subsection (4), the division
834     shall immediately suspend or revoke the electronic data system's access to opioid prescription
835     information in the database.
836          (ii) If the division determines by audit or other means that an EDS user is not in
837     compliance with rules established by the division under Subsection (4), the division shall
838     immediately suspend or revoke the EDS user's access to opioid prescription information in the
839     database via an electronic data system.
840          (iii) If the division suspends or revokes access to opioid prescription information in the
841     database under Subsection (6)(c)(i) or (6)(c)(ii), the division shall also take any other

842     appropriate corrective or disciplinary action authorized by this chapter or title.