UT
Utah Senate Bill SB0312

Utah 2025 Regular Session

Utah Senate Bill SB0312 Compare Versions

OldNewDifferences
1-Enrolled Copy S.B. 312
1+03-05 15:06 1st Sub. (Green) S.B. 312
2+Evan J. Vickers proposes the following substitute bill:
23 1
34 Pharmacy Practice Amendments
45 2025 GENERAL SESSION
56 STATE OF UTAH
67 Chief Sponsor: Evan J. Vickers
78 House Sponsor: Bridger Bolinder
89 2
910
1011 3
1112 LONG TITLE
1213 4
1314 General Description:
1415 5
1516 This bill amends provisions related to pharmacists and pharmacies.
1617 6
1718 Highlighted Provisions:
1819 7
1920 This bill:
2021 8
2122 ▸ recognizes a pharmacist as a health care provider in limited circumstances;
2223 9
2324 ▸ addresses a prescription for a device that is necessary to ensure the appropriate delivery of
2425 10
2526 the prescribed drug;
2627 11
2728 ▸ amends the advanced written notice requirement for an audit of pharmacy records;
2829 12
2930 ▸ modifies the definition of "eligible pharmacy" for the Charitable Prescription Drug
3031 13
3132 Recycling Act; and
3233 14
3334 ▸ makes technical and conforming changes.
3435 15
3536 Money Appropriated in this Bill:
3637 16
3738 None
3839 17
3940 Other Special Clauses:
4041 18
4142 None
4243 19
4344 Utah Code Sections Affected:
4445 20
4546 AMENDS:
4647 21
4748 58-17b-102, as last amended by Laws of Utah 2024, Chapter 507
4849 22
4950 58-17b-610.8, as last amended by Laws of Utah 2024, Chapter 507
5051 23
5152 58-17b-622, as last amended by Laws of Utah 2024, Chapter 210
5253 24
5354 58-17b-902, as last amended by Laws of Utah 2023, Chapter 329
5455 25
5556 ENACTS:
5657 26
5758 31A-22-662, Utah Code Annotated 1953
5859 27
59- S.B. 312 Enrolled Copy
60+
6061 28
6162 Be it enacted by the Legislature of the state of Utah:
63+1st Sub. S.B. 312 1st Sub. (Green) S.B. 312 03-05 15:06
6264 29
6365 Section 1. Section 31A-22-662 is enacted to read:
6466 30
6567 31A-22-662 . Pharmacist as a health care provider.
6668 31
6769 (1) As used in this section, "pharmacist" means the same as that term is defined in Section
6870 32
6971 58-17b-102.
7072 33
7173 (2) An insurer that provides a health benefit plan shall consider a pharmacist as a health
7274 34
7375 care provider for a consultation that is provided to an enrollee regarding the pharmacist:
7476 35
75-(a) prescribing a nebulizer, a spacer for use with a nebulizer or inhaler, or a diabetic
77+ Ĥ→ [(a) dispensing a refill for a prescription in an emergency as described in Section
7678 36
77-supply as described in Subsection 58-17b-610.8(3); or
79+58-17b-608;]
7880 37
79-(b) prescribing a prescription drug or device as described in Section 58-17b-627.
81+[(b) dispensing a refill for an exhausted prescription for insulin in accordance with ] ←Ĥ
8082 38
83+ Ĥ→ [Section 58-17b-608.2;]
84+39
85+[(c)] (a) ←Ĥ prescribing a nebulizer, a spacer for use with a nebulizer or inhaler, or a
86+39a
87+diabetic
88+40
89+supply as described in Subsection 58-17b-610.8(3); Ĥ→ or
90+41
91+[(d)] (b) ←Ĥ prescribing a prescription drug or device as described in Section
92+41a
93+58-17b-627 Ĥ→ [; or] .
94+42
95+[(e) dispensing a drug as described in Section 58-17b-1004.] ←Ĥ
96+43
8197 (3) Subsection (2) only applies if the health benefit plan covers the prescription drug or
82-39
98+44
8399 device.
84-40
100+45
85101 (4) This section applies to a health benefit plan renewed or entered into on or after January
86-41
102+46
87103 1, 2026.
88-42
104+47
89105 Section 2. Section 58-17b-102 is amended to read:
90-43
106+48
91107 58-17b-102 . Definitions.
92-44
108+49
93109 In addition to the definitions in Section 58-1-102, as used in this chapter:
94-45
110+50
95111 (1) "Administering" means:
96-46
112+51
97113 (a) the direct application of a prescription drug or device, whether by injection,
98-47
114+52
99115 inhalation, ingestion, or by any other means, to the body of a human patient or
100-48
116+53
101117 research subject by another person; or
102-49
118+54
103119 (b) the placement by a veterinarian with the owner or caretaker of an animal or group of
104-50
120+55
105121 animals of a prescription drug for the purpose of injection, inhalation, ingestion, or
106-51
122+56
107123 any other means directed to the body of the animal by the owner or caretaker in
108-52
124+57
109125 accordance with written or verbal directions of the veterinarian.
110-53
126+58
111127 (2) "Adulterated drug or device" means a drug or device considered adulterated under 21
112-54
128+59
113129 U.S.C. Sec. 351 (2003).
114-55
130+- 2 - 03-05 15:06 1st Sub. (Green) S.B. 312
131+60
115132 (3)(a) "Analytical laboratory" means a facility in possession of prescription drugs for the
116-56
133+61
117134 purpose of analysis.
118-57
135+62
119136 (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
120-58
137+63
121138 used as standards and controls in performing drug monitoring or drug screening
122-59
139+64
123140 analysis if the prescription drugs are prediluted in a human or animal body fluid,
124-60
141+65
125142 human or animal body fluid components, organic solvents, or inorganic buffers at a
126-61
143+66
127144 concentration not exceeding one milligram per milliliter when labeled or otherwise
128-- 2 - Enrolled Copy S.B. 312
129-62
145+67
130146 designated as being for in vitro diagnostic use.
131-63
147+68
132148 (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by the
133-64
149+69
134150 use of prescription drugs.
135-65
151+70
136152 (5) "Automated pharmacy systems" includes mechanical systems which perform operations
137-66
153+71
138154 or activities, other than compounding or administration, relative to the storage,
139-67
155+72
140156 packaging, dispensing, or distribution of medications, and which collect, control, and
141-68
157+73
142158 maintain all transaction information.
143-69
159+74
144160 (6) "Beyond use date" means the date determined by a pharmacist and placed on a
145-70
161+75
146162 prescription label at the time of dispensing that indicates to the patient or caregiver a
147-71
163+76
148164 time beyond which the contents of the prescription are not recommended to be used.
149-72
165+77
150166 (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created in
151-73
167+78
152168 Section 58-17b-201.
153-74
169+79
154170 (8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
155-75
171+80
156172 underserved area, used for the storage and dispensing of prescription drugs, which is
157-76
173+81
158174 dependent upon, stocked by, and supervised by a pharmacist in another licensed
159-77
175+82
160176 pharmacy designated and approved by the division as the parent pharmacy.
161-78
177+83
162178 (9) "Centralized prescription processing" means the processing by a pharmacy of a request
163-79
179+84
164180 from another pharmacy to fill or refill a prescription drug order or to perform processing
165-80
181+85
166182 functions such as dispensing, drug utilization review, claims adjudication, refill
167-81
183+86
168184 authorizations, and therapeutic interventions.
169-82
185+87
170186 (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a retail
171-83
187+88
172188 pharmacy to compound or dispense a drug or dispense a device to the public under a
173-84
189+89
174190 prescription order.
175-85
191+90
176192 (11) "Class B pharmacy":
177-86
193+91
178194 (a) means a pharmacy located in Utah:
179-87
195+92
180196 (i) that is authorized to provide pharmaceutical care for patients in an institutional
181-88
197+93
182198 setting; and
183-89
199+- 3 - 1st Sub. (Green) S.B. 312 03-05 15:06
200+94
184201 (ii) whose primary purpose is to provide a physical environment for patients to obtain
185-90
202+95
186203 health care services; and
187-91
204+96
188205 (b)(i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
189-92
206+97
190207 (ii) pharmaceutical administration and sterile product preparation facilities.
191-93
208+98
192209 (12) "Class C pharmacy" means a pharmacy that engages in the manufacture, production,
193-94
210+99
194211 wholesale, or distribution of drugs or devices in Utah.
195-95
212+100
196213 (13) "Class D pharmacy" means a nonresident pharmacy.
197-- 3 - S.B. 312 Enrolled Copy
198-96
214+101
199215 (14) "Class E pharmacy" means all other pharmacies.
200-97
216+102
201217 (15)(a) "Closed-door pharmacy" means a pharmacy that:
202-98
218+103
203219 (i) provides pharmaceutical care to a defined and exclusive group of patients who
204-99
220+104
205221 have access to the services of the pharmacy because they are treated by or have an
206-100
222+105
207223 affiliation with a specific entity, including a health maintenance organization or an
208-101
224+106
209225 infusion company; or
210-102
226+107
211227 (ii) engages exclusively in the practice of telepharmacy and does not serve walk-in
212-103
228+108
213229 retail customers.
214-104
230+109
215231 (b) "Closed-door pharmacy" does not include a hospital pharmacy, a retailer of goods to
216-105
232+110
217233 the general public, or the office of a practitioner.
218-106
234+111
219235 (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or more
220-107
236+112
221237 pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
222-108
238+113
223239 more practitioners under protocol whereby the pharmacist may perform certain
224-109
240+114
225241 pharmaceutical care functions authorized by the practitioner or practitioners under
226-110
242+115
227243 certain specified conditions or limitations.
228-111
244+116
229245 (17) "Collaborative pharmacy practice agreement" means a written and signed agreement
230-112
246+117
231247 between one or more pharmacists and one or more practitioners that provides for
232-113
248+118
233249 collaborative pharmacy practice for the purpose of drug therapy management of patients
234-114
250+119
235251 and prevention of disease of human subjects.
236-115
252+120
237253 (18)(a) "Compounding" means the preparation, mixing, assembling, packaging, or
238-116
254+121
239255 labeling of a limited quantity drug, sterile product, or device:
240-117
256+122
241257 (i) as the result of a practitioner's prescription order or initiative based on the
242-118
258+123
243259 practitioner, patient, or pharmacist relationship in the course of professional
244-119
260+124
245261 practice;
246-120
262+125
247263 (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis
248-121
264+126
249265 and not for sale or dispensing; or
250-122
266+127
251267 (iii) in anticipation of prescription drug orders based on routine, regularly observed
252-123
268+- 4 - 03-05 15:06 1st Sub. (Green) S.B. 312
269+128
253270 prescribing patterns.
254-124
271+129
255272 (b) "Compounding" does not include:
256-125
273+130
257274 (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale
258-126
275+131
259276 to another pharmacist or pharmaceutical facility;
260-127
277+132
261278 (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
262-128
279+133
263280 dosage form which is regularly and commonly available from a manufacturer in
264-129
281+134
265282 quantities and strengths prescribed by a practitioner; or
266-- 4 - Enrolled Copy S.B. 312
267-130
283+135
268284 (iii) the preparation of a prescription drug, sterile product, or device which has been
269-131
285+136
270286 withdrawn from the market for safety reasons.
271-132
287+137
272288 (19) "Confidential information" has the same meaning as "protected health information"
273-133
289+138
274290 under the Standards for Privacy of Individually Identifiable Health Information, 45
275-134
291+139
276292 C.F.R. Parts 160 and 164.
277-135
293+140
278294 (20) "Controlled substance" means the same as that term is defined in Section 58-37-2.
279-136
280-(21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter 417, Sec.
281-137
295+141
296+(21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter 417,
297+141a
298+Sec.
299+142
282300 3a(ff) which is incorporated by reference.
283-138
301+143
284302 (22) "Dispense" means the interpretation, evaluation, and implementation of a prescription
285-139
303+144
286304 drug order or device or nonprescription drug or device under a lawful order of a
287-140
305+145
288306 practitioner in a suitable container appropriately labeled for subsequent administration to
289-141
307+146
290308 or use by a patient, research subject, or an animal.
291-142
309+147
292310 (23) "Dispensing medical practitioner" means an individual who is:
293-143
311+148
294312 (a) currently licensed as:
295-144
313+149
296314 (i) a physician and surgeon under Chapter 67, Utah Medical Practice Act;
297-145
315+150
298316 (ii) an osteopathic physician and surgeon under Chapter 68, Utah Osteopathic
299-146
317+151
300318 Medical Practice Act;
301-147
319+152
302320 (iii) a physician assistant under Chapter 70a, Utah Physician Assistant Act;
303-148
321+153
304322 (iv) a nurse practitioner under Chapter 31b, Nurse Practice Act; or
305-149
323+154
306324 (v) an optometrist under Chapter 16a, Utah Optometry Practice Act, if the
307-150
325+155
308326 optometrist is acting within the scope of practice for an optometrist; and
309-151
327+156
310328 (b) licensed by the division under the Pharmacy Practice Act to engage in the practice of
311-152
329+157
312330 a dispensing medical practitioner.
313-153
331+158
314332 (24) "Dispensing medical practitioner clinic pharmacy" means a closed-door pharmacy
315-154
333+159
316334 located within a licensed dispensing medical practitioner's place of practice.
317-155
335+160
318336 (25) "Distribute" means to deliver a drug or device other than by administering or
319-156
337+- 5 - 1st Sub. (Green) S.B. 312 03-05 15:06
338+161
320339 dispensing.
321-157
340+162
322341 (26)(a) "Drug" means:
323-158
342+163
324343 (i) a substance recognized in the official United States Pharmacopoeia, official
325-159
344+164
326345 Homeopathic Pharmacopoeia of the United States, or official National Formulary,
327-160
346+165
328347 or any supplement to any of them, intended for use in the diagnosis, cure,
329-161
348+166
330349 mitigation, treatment, or prevention of disease in humans or animals;
331-162
350+167
332351 (ii) a substance that is required by any applicable federal or state law or rule to be
333-163
352+168
334353 dispensed by prescription only or is restricted to administration by practitioners
335-- 5 - S.B. 312 Enrolled Copy
336-164
354+169
337355 only;
338-165
356+170
339357 (iii) a substance other than food intended to affect the structure or any function of the
340-166
358+171
341359 body of humans or other animals; and
342-167
360+172
343361 (iv) substances intended for use as a component of any substance specified in
344-168
362+173
345363 Subsections (26)(a)(i) through [(iv)] (iii).
346-169
364+174
347365 (b) "Drug" does not include dietary supplements.
348-170
366+175
349367 (27) "Drug regimen review" includes the following activities:
350-171
368+176
351369 (a) evaluation of the prescription drug order and patient record for:
352-172
370+177
353371 (i) known allergies;
354-173
372+178
355373 (ii) rational therapy-contraindications;
356-174
374+179
357375 (iii) reasonable dose and route of administration; and
358-175
376+180
359377 (iv) reasonable directions for use;
360-176
378+181
361379 (b) evaluation of the prescription drug order and patient record for duplication of therapy;
362-177
380+182
363381 (c) evaluation of the prescription drug order and patient record for the following
364-178
382+183
365383 interactions:
366-179
384+184
367385 (i) drug-drug;
368-180
386+185
369387 (ii) drug-food;
370-181
388+186
371389 (iii) drug-disease; and
372-182
390+187
373391 (iv) adverse drug reactions; and
374-183
392+188
375393 (d) evaluation of the prescription drug order and patient record for proper utilization,
376-184
394+189
377395 including over- or under-utilization, and optimum therapeutic outcomes.
378-185
396+190
379397 (28) "Drug sample" means a prescription drug packaged in small quantities consistent with
380-186
398+191
381399 limited dosage therapy of the particular drug, which is marked "sample", is not intended
382-187
400+192
383401 to be sold, and is intended to be provided to practitioners for the immediate needs of
384-188
402+193
385403 patients for trial purposes or to provide the drug to the patient until a prescription can be
386-189
404+194
387405 filled by the patient.
388-190
406+- 6 - 03-05 15:06 1st Sub. (Green) S.B. 312
407+195
389408 (29) "Electronic signature" means a trusted, verifiable, and secure electronic sound, symbol,
390-191
409+196
391410 or process attached to or logically associated with a record and executed or adopted by a
392-192
411+197
393412 person with the intent to sign the record.
394-193
413+198
395414 (30) "Electronic transmission" means transmission of information in electronic form or the
396-194
415+199
397416 transmission of the exact visual image of a document by way of electronic equipment.
398-195
417+200
399418 (31) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to inpatients of
400-196
419+201
401420 a general acute hospital or specialty hospital licensed by the Department of Health and
402-197
421+202
403422 Human Services under Title 26B, Chapter 2, Part 2, Health Care Facility Licensing and
404-- 6 - Enrolled Copy S.B. 312
405-198
423+203
406424 Inspection.
407-199
425+204
408426 (32) "Legend drug" has the same meaning as prescription drug.
409-200
427+205
410428 (33) "Licensed pharmacy technician" means an individual licensed with the division, that
411-201
429+206
412430 may, under the supervision of a pharmacist, perform the activities involved in the
413-202
431+207
414432 technician practice of pharmacy.
415-203
433+208
416434 (34) "Manufacturer" means a person or business physically located in Utah licensed to be
417-204
435+209
418436 engaged in the manufacturing of drugs or devices.
419-205
437+210
420438 (35)(a) "Manufacturing" means:
421-206
439+211
422440 (i) the production, preparation, propagation, conversion, or processing of a drug or
423-207
441+212
424442 device, either directly or indirectly, by extraction from substances of natural origin
425-208
443+213
426444 or independently by means of chemical or biological synthesis, or by a
427-209
445+214
428446 combination of extraction and chemical synthesis, and includes any packaging or
429-210
447+215
430448 repackaging of the substance or labeling or relabeling of its container; and
431-211
449+216
432450 (ii) the promotion and marketing of such drugs or devices.
433-212
451+217
434452 (b) "Manufacturing" includes the preparation and promotion of commercially available
435-213
453+218
436454 products from bulk compounds for resale by pharmacies, practitioners, or other
437-214
455+219
438456 persons.
439-215
457+220
440458 (c) "Manufacturing" does not include the preparation or compounding of a drug by a
441-216
459+221
442460 pharmacist, pharmacy intern, or practitioner for that individual's own use or the
443-217
461+222
444462 preparation, compounding, packaging, labeling of a drug, or incident to research,
445-218
463+223
446464 teaching, or chemical analysis.
447-219
465+224
448466 (36) "Medical order" means a lawful order of a practitioner which may include a
449-220
467+225
450468 prescription drug order.
451-221
469+226
452470 (37) "Medication profile" or "profile" means a record system maintained as to drugs or
453-222
471+227
454472 devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to
455-223
473+228
456474 analyze the profile to provide pharmaceutical care.
457-224
475+- 7 - 1st Sub. (Green) S.B. 312 03-05 15:06
476+229
458477 (38) "Misbranded drug or device" means a drug or device considered misbranded under 21
459-225
478+230
460479 U.S.C. Sec. 352 (2003).
461-226
480+231
462481 (39)(a) "Nonprescription drug" means a drug which:
463-227
482+232
464483 (i) may be sold without a prescription; and
465-228
484+233
466485 (ii) is labeled for use by the consumer in accordance with federal law.
467-229
486+234
468487 (b) "Nonprescription drug" includes homeopathic remedies.
469-230
488+235
470489 (40) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
471-231
490+236
472491 person in Utah.
473-- 7 - S.B. 312 Enrolled Copy
474-232
492+237
475493 (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
476-233
494+238
477495 (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located outside
478-234
496+239
479497 the state that is licensed and in good standing in another state, that:
480-235
498+240
481499 (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
482-236
500+241
483501 this state pursuant to a lawfully issued prescription;
484-237
502+242
485503 (b) provides information to a patient in this state on drugs or devices which may include,
486-238
504+243
487505 but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
488-239
506+244
489507 or
490-240
508+245
491509 (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
492-241
510+246
493511 effects of drugs.
494-242
512+247
495513 (43) "Patient counseling" means the written and oral communication by the pharmacist or
496-243
514+248
497515 pharmacy intern of information, to the patient or caregiver, in order to ensure proper use
498-244
516+249
499517 of drugs, devices, and dietary supplements.
500-245
518+250
501519 (44) "Pharmaceutical administration facility" means a facility, agency, or institution in
502-246
520+251
503521 which:
504-247
522+252
505523 (a) prescription drugs or devices are held, stored, or are otherwise under the control of
506-248
524+253
507525 the facility or agency for administration to patients of that facility or agency;
508-249
526+254
509527 (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist or
510-250
528+255
511529 pharmacy intern with whom the facility has established a prescription drug
512-251
530+256
513531 supervising relationship under which the pharmacist or pharmacy intern provides
514-252
532+257
515533 counseling to the facility or agency staff as required, and oversees drug control,
516-253
534+258
517535 accounting, and destruction; and
518-254
536+259
519537 (c) prescription drugs are professionally administered in accordance with the order of a
520-255
538+260
521539 practitioner by an employee or agent of the facility or agency.
522-256
540+261
523541 (45)(a) "Pharmaceutical care" means carrying out the following in collaboration with a
524-257
542+262
525543 prescribing practitioner, and in accordance with division rule:
526-258
544+- 8 - 03-05 15:06 1st Sub. (Green) S.B. 312
545+263
527546 (i) designing, implementing, and monitoring a therapeutic drug plan intended to
528-259
547+264
529548 achieve favorable outcomes related to a specific patient for the purpose of curing
530-260
549+265
531550 or preventing the patient's disease;
532-261
551+266
533552 (ii) eliminating or reducing a patient's symptoms; or
534-262
553+267
535554 (iii) arresting or slowing a disease process.
536-263
555+268
537556 (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
538-264
557+269
539558 prescribing practitioner.
540-265
559+270
541560 (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
542-- 8 - Enrolled Copy S.B. 312
543-266
561+271
544562 distributing, manufacturing, or wholesaling of prescription drugs or devices within or
545-267
563+272
546564 into this state.
547-268
565+273
548566 (47)(a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
549-269
567+274
550568 engaged in the business of wholesale vending or selling of a prescription drug or
551-270
569+275
552570 device to other than a consumer or user of the prescription drug or device that the
553-271
571+276
554572 pharmaceutical facility has not produced, manufactured, compounded, or dispensed.
555-272
573+277
556574 (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical facility
557-273
575+278
558576 carrying out the following business activities:
559-274
577+279
560578 (i) intracompany sales;
561-275
579+280
562580 (ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
563-276
581+281
564582 purchase, or trade a prescription drug or device, if the activity is carried out
565-277
583+282
566584 between one or more of the following entities under common ownership or
567-278
585+283
568586 common administrative control, as defined by division rule:
569-279
587+284
570588 (A) hospitals;
571-280
589+285
572590 (B) pharmacies;
573-281
591+286
574592 (C) chain pharmacy warehouses, as defined by division rule; or
575-282
593+287
576594 (D) other health care entities, as defined by division rule;
577-283
595+288
578596 (iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
579-284
597+289
580598 purchase, or trade a prescription drug or device, for emergency medical reasons,
581-285
599+290
582600 including supplying another pharmaceutical facility with a limited quantity of a
583-286
601+291
584602 drug, if:
585-287
603+292
586604 (A) the facility is unable to obtain the drug through a normal distribution channel
587-288
605+293
588606 in sufficient time to eliminate the risk of harm to a patient that would result
589-289
607+294
590608 from a delay in obtaining the drug; and
591-290
609+295
592610 (B) the quantity of the drug does not exceed an amount reasonably required for
593-291
611+296
594612 immediate dispensing to eliminate the risk of harm;
595-292
613+- 9 - 1st Sub. (Green) S.B. 312 03-05 15:06
614+297
596615 (iv) the distribution of a prescription drug or device as a sample by representatives of
597-293
616+298
598617 a manufacturer; and
599-294
618+299
600619 (v) the distribution of prescription drugs, if:
601-295
620+300
602621 (A) the facility's total distribution-related sales of prescription drugs does not
603-296
622+301
604623 exceed 5% of the facility's total prescription drug sales; and
605-297
624+302
606625 (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
607-298
626+303
608627 (48) "Pharmacist" means an individual licensed by this state to engage in the practice of
609-299
628+304
610629 pharmacy.
611-- 9 - S.B. 312 Enrolled Copy
612-300
630+305
613631 (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing who
614-301
632+306
615633 accepts responsibility for the operation of a pharmacy in conformance with all laws and
616-302
634+307
617635 rules pertinent to the practice of pharmacy and the distribution of drugs, and who is
618-303
636+308
619637 personally in full and actual charge of the pharmacy and all personnel.
620-304
638+309
621639 (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with one or
622-305
640+310
623641 more years of licensed experience. The preceptor serves as a teacher, example of
624-306
642+311
625643 professional conduct, and supervisor of interns in the professional practice of pharmacy.
626-307
644+312
627645 (51) "Pharmacy" means any place where:
628-308
646+313
629647 (a) drugs are dispensed;
630-309
648+314
631649 (b) pharmaceutical care is provided;
632-310
650+315
633651 (c) drugs are processed or handled for eventual use by a patient; or
634-311
652+316
635653 (d) drugs are used for the purpose of analysis or research.
636-312
654+317
637655 (52) "Pharmacy benefits manager or coordinator" means a person or entity that provides a
638-313
656+318
639657 pharmacy benefits management service as defined in Section 31A-46-102 on behalf of a
640-314
658+319
641659 self-insured employer, insurance company, health maintenance organization, or other
642-315
660+320
643661 plan sponsor, as defined by rule.
644-316
662+321
645663 (53) "Pharmacy intern" means an individual licensed by this state to engage in practice as a
646-317
664+322
647665 pharmacy intern.
648-318
666+323
649667 (54) "Pharmacy manager" means:
650-319
668+324
651669 (a) a pharmacist-in-charge;
652-320
670+325
653671 (b) a licensed pharmacist designated by a licensed pharmacy to consult on the
654-321
672+326
655673 pharmacy's administration;
656-322
674+327
657675 (c) an individual who manages the facility in which a licensed pharmacy is located;
658-323
676+328
659677 (d) an individual who oversees the operations of a licensed pharmacy;
660-324
661-(e) an immediate supervisor of an individual described in Subsections (54)(a) through (d);
662-325
678+329
679+(e) an immediate supervisor of an individual described in Subsections (54)(a) through
680+329a
681+(d);
682+- 10 - 03-05 15:06 1st Sub. (Green) S.B. 312
683+330
663684 or
664-326
685+331
665686 (f) another operations or site manager of a licensed pharmacy.
666-327
687+332
667688 (55) "Pharmacy technician training program" means an approved technician training
668-328
689+333
669690 program providing education for pharmacy technicians.
670-329
691+334
671692 (56)(a) "Practice as a dispensing medical practitioner" means the practice of pharmacy,
672-330
693+335
673694 specifically relating to the dispensing of a prescription drug in accordance with Part
674-331
695+336
675696 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic
676-332
697+337
677698 Pharmacy, and division rule adopted after consultation with the Board of pharmacy
678-333
699+338
679700 and the governing boards of the practitioners described in Subsection (23)(a).
680-- 10 - Enrolled Copy S.B. 312
681-334
701+339
682702 (b) "Practice as a dispensing medical practitioner" does not include:
683-335
703+340
684704 (i) using a vending type of dispenser as defined by the division by administrative
685-336
705+341
686706 rule; or
687-337
707+342
688708 (ii) except as permitted by Section 58-17b-805, dispensing of a controlled substance
689-338
709+343
690710 as defined in Section 58-37-2.
691-339
711+344
692712 (57) "Practice as a licensed pharmacy technician" means engaging in practice as a
693-340
713+345
694714 pharmacy technician under the general supervision of a licensed pharmacist and in
695-341
715+346
696716 accordance with a scope of practice defined by division rule made in collaboration with
697-342
717+347
698718 the board.
699-343
719+348
700720 (58) "Practice of pharmacy" includes the following:
701-344
721+349
702722 (a) providing pharmaceutical care;
703-345
723+350
704724 (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
705-346
725+351
706726 practice agreement;
707-347
727+352
708728 (c) compounding, packaging, labeling, dispensing, administering, and the coincident
709-348
729+353
710730 distribution of prescription drugs or devices, provided that the administration of a
711-349
731+354
712732 prescription drug or device is:
713-350
733+355
714734 (i) pursuant to a lawful order of a practitioner when one is required by law; and
715-351
735+356
716736 (ii) in accordance with written guidelines or protocols:
717-352
737+357
718738 (A) established by the licensed facility in which the prescription drug or device is
719-353
739+358
720740 to be administered on an inpatient basis; or
721-354
741+359
722742 (B) approved by the division, in collaboration with the board and, when
723-355
743+360
724744 appropriate, the Medical Licensing Board, created in Section 58-67-201, if the
725-356
745+361
726746 prescription drug or device is to be administered on an outpatient basis solely
727-357
747+362
728748 by a licensed pharmacist;
729-358
749+363
730750 (d) participating in drug utilization review;
731-359
751+- 11 - 1st Sub. (Green) S.B. 312 03-05 15:06
752+364
732753 (e) ensuring proper and safe storage of drugs and devices;
733-360
754+365
734755 (f) maintaining records of drugs and devices in accordance with state and federal law
735-361
756+366
736757 and the standards and ethics of the profession;
737-362
758+367
738759 (g) providing information on drugs or devices, which may include advice relating to
739-363
760+368
740761 therapeutic values, potential hazards, and uses;
741-364
762+369
742763 (h) providing drug product equivalents;
743-365
764+370
744765 (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
745-366
766+371
746767 technicians;
747-367
768+372
748769 (j) providing patient counseling, including adverse and therapeutic effects of drugs;
749-- 11 - S.B. 312 Enrolled Copy
750-368
770+373
751771 (k) providing emergency refills as defined by rule;
752-369
772+374
753773 (l) telepharmacy;
754-370
774+375
755775 (m) formulary management intervention;
756-371
776+376
757777 (n) prescribing and dispensing a self-administered hormonal contraceptive in accordance
758-372
778+377
759779 with Title 26B, Chapter 4, Part 5, Treatment Access; and
760-373
780+378
761781 (o) issuing a prescription in accordance with Section 58-17b-610.8 or 58-17b-627.
762-374
782+379
763783 (59) "Practice of telepharmacy" means the practice of pharmacy through the use of
764-375
784+380
765785 telecommunications and information technologies.
766-376
786+381
767787 (60) "Practice of telepharmacy across state lines" means the practice of pharmacy through
768-377
788+382
769789 the use of telecommunications and information technologies that occurs when the
770-378
790+383
771791 patient is physically located within one jurisdiction and the pharmacist is located in
772-379
792+384
773793 another jurisdiction.
774-380
794+385
775795 (61) "Practitioner" means an individual currently licensed, registered, or otherwise
776-381
796+386
777797 authorized by the appropriate jurisdiction to prescribe and administer drugs in the course
778-382
798+387
779799 of professional practice.
780-383
800+388
781801 (62) "Prescribe" means to issue a prescription:
782-384
802+389
783803 (a) orally or in writing; or
784-385
804+390
785805 (b) by telephone, facsimile transmission, computer, or other electronic means of
786-386
806+391
787807 communication as defined by division rule.
788-387
808+392
789809 (63) "Prescription" means an order issued:
790-388
810+393
791811 (a) by a licensed practitioner in the course of that practitioner's professional practice or
792-389
812+394
793813 by collaborative pharmacy practice agreement; and
794-390
814+395
795815 (b) for a controlled substance or other prescription drug or device for use by a patient or
796-391
816+396
797817 an animal.
798-392
818+397
799819 (64) "Prescription device" means an instrument, apparatus, implement, machine,
800-393
820+- 12 - 03-05 15:06 1st Sub. (Green) S.B. 312
821+398
801822 contrivance, implant, in vitro reagent, or other similar or related article, and any
802-394
823+399
803824 component part or accessory, which is required under federal or state law to be
804-395
825+400
805826 prescribed by a practitioner and dispensed by or through a person or entity licensed
806-396
827+401
807828 under this chapter or exempt from licensure under this chapter.
808-397
829+402
809830 (65) "Prescription drug" means a drug that is required by federal or state law or rule to be
810-398
831+403
811832 dispensed only by prescription or is restricted to administration only by practitioners.
812-399
833+404
813834 (66) "Repackage":
814-400
835+405
815836 (a) means changing the container, wrapper, or labeling to further the distribution of a
816-401
837+406
817838 prescription drug; and
818-- 12 - Enrolled Copy S.B. 312
819-402
839+407
820840 (b) does not include:
821-403
841+408
822842 (i) Subsection (66)(a) when completed by the pharmacist responsible for dispensing
823-404
843+409
824844 the product to a patient; or
825-405
845+410
826846 (ii) changing or altering a label as necessary for a dispensing practitioner under Part
827-406
847+411
828848 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic
829-407
849+412
830850 Pharmacy, for dispensing a product to a patient.
831-408
851+413
832852 (67) "Research using pharmaceuticals" means research:
833-409
853+414
834854 (a) conducted in a research facility, as defined by division rule, that is associated with a
835-410
855+415
836856 university or college in the state accredited by the Northwest Commission on
837-411
857+416
838858 Colleges and Universities;
839-412
859+417
840860 (b) requiring the use of a controlled substance, prescription drug, or prescription device;
841-413
861+418
842862 (c) that uses the controlled substance, prescription drug, or prescription device in
843-414
863+419
844864 accordance with standard research protocols and techniques, including, if required,
845-415
865+420
846866 those approved by an institutional review committee; and
847-416
867+421
848868 (d) that includes any documentation required for the conduct of the research and the
849-417
869+422
850870 handling of the controlled substance, prescription drug, or prescription device.
851-418
871+423
852872 (68) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugs and
853-419
873+424
854874 devices to the general public.
855-420
875+425
856876 (69)(a) "Self-administered hormonal contraceptive" means a self-administered hormonal
857-421
877+426
858878 contraceptive that is approved by the United States Food and Drug Administration to
859-422
879+427
860880 prevent pregnancy.
861-423
881+428
862882 (b) "Self-administered hormonal contraceptive" includes an oral hormonal contraceptive,
863-424
883+429
864884 a hormonal vaginal ring, and a hormonal contraceptive patch.
865-425
885+430
866886 (c) "Self-administered hormonal contraceptive" does not include any drug intended to
867-426
887+431
868888 induce an abortion, as that term is defined in Section 76-7-301.
869-427
889+- 13 - 1st Sub. (Green) S.B. 312 03-05 15:06
890+432
870891 (70) "Self-audit" means an internal evaluation of a pharmacy to determine compliance with
871-428
892+433
872893 this chapter.
873-429
894+434
874895 (71) "Supervising pharmacist" means a pharmacist who is overseeing the operation of the
875-430
896+435
876897 pharmacy during a given day or shift.
877-431
898+436
878899 (72) "Supportive personnel" means unlicensed individuals who:
879-432
900+437
880901 (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
881-433
902+438
882903 pharmacy technician in nonjudgmental duties not included in the definition of the
883-434
904+439
884905 practice of pharmacy, practice of a pharmacy intern, or practice of a licensed
885-435
906+440
886907 pharmacy technician, and as those duties may be further defined by division rule
887-- 13 - S.B. 312 Enrolled Copy
888-436
908+441
889909 adopted in collaboration with the board; and
890-437
910+442
891911 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
892-438
912+443
893913 collaboration with the board.
894-439
914+444
895915 (73) "Unlawful conduct" means the same as that term is defined in Sections 58-1-501 and
896-440
916+445
897917 58-17b-501.
898-441
918+446
899919 (74) "Unprofessional conduct" means the same as that term is defined in Sections 58-1-501
900-442
920+447
901921 and 58-17b-502 and may be further defined by rule.
902-443
922+448
903923 (75) "Veterinary pharmaceutical facility" means a pharmaceutical facility that dispenses
904-444
924+449
905925 drugs intended for use by animals or for sale to veterinarians for the administration for
906-445
926+450
907927 animals.
908-446
928+451
909929 (76) "Written communication" means a physical document, or an electronic
910-447
930+452
911931 communication, by or from which the recipient may read or access the information
912-448
932+453
913933 intended to be communicated, including:
914-449
934+454
915935 (a) email;
916-450
936+455
917937 (b) text message; and
918-451
938+456
919939 (c) quick response (QR) code.
920-452
940+457
921941 Section 3. Section 58-17b-610.8 is amended to read:
922-453
942+458
923943 58-17b-610.8 . Prescription devices.
924-454
944+459
925945 (1) The following documents from a prescribing practitioner [shall be] are considered a
926-455
946+460
927947 prescription for purposes of dispensing of and payment for a device described in
928-456
948+461
929949 Subsection [(3)] (4), if the device is prescribed or indicated by the document and the
930-457
950+462
931951 document is on file with a pharmacy:
932-458
952+463
933953 (a) a written prescription; or
934-459
954+464
935955 (b) a written record of a patient's:
936-460
956+465
937957 (i) current diagnosis; or
938-461
958+- 14 - 03-05 15:06 1st Sub. (Green) S.B. 312
959+466
939960 (ii) treatment protocol.
940-462
961+467
941962 (2) A pharmacist or pharmacy intern at a pharmacy at which a document that is considered
942-463
963+468
943964 a prescription under Subsection (1) is on file may dispense under prescription a device
944-464
965+469
945966 described in Subsection [(3)] (4) to the patient in accordance with:
946-465
967+470
947968 (a) the document that is considered a prescription under Subsection (1); and
948-466
969+471
949970 (b) rules made by the division under Subsection [(4)] (5).
950-467
951-(3) A pharmacist may prescribe a device described in Subsection (4) if:
952-468
953-(a) the device is not prescribed or indicated by the document described in Subsection (1)
954-469
955-that is on file with the pharmacy; and
956-- 14 - Enrolled Copy S.B. 312
957-470
958-(b) the pharmacist determines that the device is necessary to ensure the appropriate
959-471
971+472
972+(3)(a) A pharmacist may prescribe a device described in Subsection (4) if:
973+473
974+(i) the device is not prescribed or indicated by the document described in Subsection
975+474
976+(1) that is on file with the pharmacy; and
977+475
978+(ii) the pharmacist determines that the device is necessary to ensure the appropriate
979+476
960980 delivery of the prescribed drug.
961-472
981+477
962982 [(3)] (4) This section applies to:
963-473
983+478
964984 (a) nebulizers;
965-474
985+479
966986 (b) spacers for use with nebulizers or inhalers; and
967-475
987+480
968988 (c) diabetic supplies.
969-476
989+481
970990 [(4)] (5) The division shall make rules in accordance with Title 63G, Chapter 3, Utah
971-477
991+482
972992 Administrative Rulemaking Act, and in consultation with the board and the Medical
973-478
993+483
974994 Licensing Board created in Section 58-67-201 to implement this section.
975-479
995+484
976996 Section 4. Section 58-17b-622 is amended to read:
977-480
997+485
978998 58-17b-622 . Pharmacy benefit management services -- Auditing of pharmacy
979-481
999+486
9801000 records -- Appeals.
981-482
1001+487
9821002 (1) [For purposes of] As used in this section:
983-483
1003+488
9841004 (a) "Audit" means a review of the records of a pharmacy by or on behalf of an entity that
985-484
1005+489
9861006 finances or reimburses the cost of health care services or pharmaceutical products.
987-485
1007+490
9881008 (b) "Audit completion date" means:
989-486
1009+491
9901010 (i) for an audit that does not require an on-site visit at the pharmacy, the date on
991-487
1011+492
9921012 which the pharmacy, in response to the initial audit request, submits records or
993-488
1013+493
9941014 other documents to the entity conducting the audit, as determined by:
995-489
1015+494
9961016 (A) postmark or other evidence of the date of mailing; or
997-490
1017+495
9981018 (B) the date of transmission if the records or other documents are transmitted
999-491
1019+496
10001020 electronically; and
1001-492
1021+497
10021022 (ii) for an audit that requires an on-site visit at a pharmacy, the date on which the
1003-493
1023+498
10041024 auditing entity completes the on-site visit, including any follow-up visits or
1005-494
1025+499
10061026 analysis which shall be completed within 60 days after the day on which the
1007-495
1027+- 15 - 1st Sub. (Green) S.B. 312 03-05 15:06
1028+500
10081029 on-site visit begins.
1009-496
1030+501
10101031 (c) "Entity" includes:
1011-497
1032+502
10121033 (i) a pharmacy benefits manager or coordinator;
1013-498
1034+503
10141035 (ii) a health benefit plan;
1015-499
1036+504
10161037 (iii) a third party administrator as defined in Section 31A-1-301;
1017-500
1038+505
10181039 (iv) a state agency; or
1019-501
1040+506
10201041 (v) a company, group, or agent that represents, or is engaged by, one of the entities
1021-502
1042+507
10221043 described in Subsections (1)(c)(i) through (iv).
1023-503
1044+508
10241045 (d) "Extrapolation" means a method of using a mathematical formula that uses the audit
1025-- 15 - S.B. 312 Enrolled Copy
1026-504
1046+509
10271047 results from a small sample of insurance claims and projects the results over a larger
1028-505
1048+510
10291049 group of insurance claims.
1030-506
1050+511
10311051 (e) "Fraud" means an intentional act of deception, misrepresentation, or concealment in
1032-507
1052+512
10331053 order to gain something of value.
1034-508
1054+513
10351055 (f) "Health benefit plan" means:
1036-509
1056+514
10371057 (i) a health benefit plan as defined in Section 31A-1-301; or
1038-510
1058+515
10391059 (ii) a health, dental, medical, Medicare supplement, or conversion program offered
1040-511
1060+516
10411061 under Title 49, Chapter 20, Public Employees' Benefit and Insurance Program Act.
1042-512
1062+517
10431063 (2)(a) Except as provided in Subsection (2)(b), this section applies to:
1044-513
1064+518
10451065 (i) a contract for the audit of a pharmacy entered into, amended, or renewed on or
1046-514
1066+519
10471067 after July 1, 2012; and
1048-515
1068+520
10491069 (ii) an entity that conducts an audit of the pharmacy records of a pharmacy licensed
1050-516
1070+521
10511071 under this chapter.
1052-517
1072+522
10531073 (b) This section does not apply to an audit of pharmacy records:
1054-518
1074+523
10551075 (i) for a federally funded prescription drug program, including:
1056-519
1076+524
10571077 (A) the state Medicaid program;
1058-520
1078+525
10591079 (B) the Medicare Part D program;
1060-521
1080+526
10611081 (C) a Department of Defense prescription drug program; and
1062-522
1082+527
10631083 (D) a Veterans Affairs prescription drug program; or
1064-523
1084+528
10651085 (ii) when fraud or other intentional and willful misrepresentation is alleged and the
1066-524
1086+529
10671087 pharmacy audit entity has evidence that the pharmacy's actions reasonably
1068-525
1088+530
10691089 indicate fraud or intentional and willful misrepresentation.
1070-526
1090+531
10711091 (3)(a) An audit that involves clinical or professional judgment shall be conducted by or
1072-527
1092+532
10731093 in consultation with a pharmacist who is employed by or working with the auditing
1074-528
1094+533
10751095 entity and who is licensed in the state or another state.
1076-529
1096+- 16 - 03-05 15:06 1st Sub. (Green) S.B. 312
1097+534
10771098 (b) If an audit is conducted on site at a pharmacy, the entity conducting the audit:
1078-530
1099+535
10791100 (i) shall give the pharmacy 10 days advanced written notice of:
1080-531
1101+536
10811102 (A) the audit; and
1082-532
1103+537
10831104 (B) the range of prescription numbers [or] and a date range for the prescription
1084-533
1105+538
10851106 numbers included in the audit; and
1086-534
1107+539
10871108 (ii) may not audit a pharmacy during the first five business days of the month, unless
1088-535
1109+540
10891110 the pharmacy agrees to the timing of the audit.
1090-536
1111+541
10911112 (c) An entity may not audit claims:
1092-537
1113+542
10931114 (i) submitted more than 18 months prior to the audit, unless:
1094-- 16 - Enrolled Copy S.B. 312
1095-538
1115+543
10961116 (A) required by federal law; or
1097-539
1117+544
10981118 (B) the originating prescription is dated in the preceding six months; or
1099-540
1119+545
11001120 (ii) that exceed 200 selected prescription claims annually.
1101-541
1121+546
11021122 (d) Subsection (3)(c)(ii) does not apply to any investigative audit that involves fraud,
1103-542
1123+547
11041124 waste, abuse, or willful misrepresentation.
1105-543
1125+548
11061126 (4)(a) An entity may not:
1107-544
1127+549
11081128 (i) include dispensing fees in the calculations of overpayments unless the prescription
1109-545
1129+550
11101130 is considered a misfill;
1111-546
1131+551
11121132 (ii) recoup funds for prescription clerical or recordkeeping errors, including
1113-547
1133+552
11141134 typographical errors, scrivener's errors, and computer errors on a required
1115-548
1135+553
11161136 document or record unless the audit entity is alleging fraud or other intentional or
1117-549
1137+554
11181138 willful misrepresentation and the audit entity has evidence that the pharmacy's
1119-550
1139+555
11201140 actions reasonably indicate fraud or intentional and willful misrepresentation;
1121-551
1141+556
11221142 (iii) recoup funds for refills dispensed in accordance with Section 58-17b-608.1,
1123-552
1143+557
11241144 unless the health benefit plan does not cover the prescription drug dispensed by
1125-553
1145+558
11261146 the pharmacy;
1127-554
1147+559
11281148 (iv) collect any funds, charge-backs, or penalties until the audit and all appeals are
1129-555
1149+560
11301150 final, unless the audit entity is alleging fraud or other intentional or willful
1131-556
1151+561
11321152 misrepresentation and the audit entity has evidence that the pharmacy's actions
1133-557
1153+562
11341154 reasonably indicate fraud or intentional and willful misrepresentation; or
1135-558
1155+563
11361156 (v) recoup funds or collect any funds, charge-backs, or penalties from a pharmacy in
1137-559
1157+564
11381158 response to a request for audit unless the pharmacy confirms to the entity the date
1139-560
1159+565
11401160 on which the pharmacy received the request for audit.
1141-561
1161+566
11421162 (b) Auditors shall only have access to previous audit reports on a particular pharmacy if
1143-562
1163+567
11441164 the previous audit was conducted by the same entity except as required for
1145-563
1165+- 17 - 1st Sub. (Green) S.B. 312 03-05 15:06
1166+568
11461167 compliance with state or federal law.
1147-564
1168+569
11481169 (5) A pharmacy subject to an audit:
1149-565
1170+570
11501171 (a) may use one or more of the following to validate a claim for a prescription, refill, or
1151-566
1172+571
11521173 change in a prescription:
1153-567
1174+572
11541175 (i) electronic or physical copies of records of a health care facility, or a health care
1155-568
1176+573
11561177 provider with prescribing authority;
1157-569
1178+574
11581179 (ii) any prescription that complies with state law;
1159-570
1180+575
11601181 (iii) the pharmacy's own physical or electronic records; or
1161-571
1182+576
11621183 (iv) the physical or electronic records, or valid copies of the physical or electronic
1163-- 17 - S.B. 312 Enrolled Copy
1164-572
1184+577
11651185 records, of a practitioner or health care facility as defined in Section 26B-2-201;
1166-573
1186+578
11671187 and
1168-574
1188+579
11691189 (b) may not be required to provide the following records to validate a claim for a
1170-575
1190+580
11711191 prescription, refill, or change in a prescription:
1172-576
1192+581
11731193 (i) if the prescription was handwritten, the physical handwritten version of the
1174-577
1194+582
11751195 prescription; or
1176-578
1196+583
11771197 (ii) a note from the practitioner regarding the patient or the prescription that is not
1178-579
1198+584
11791199 otherwise required for a prescription under state or federal law.
1180-580
1200+585
11811201 (6)(a)(i) An entity that audits a pharmacy shall establish:
1182-581
1202+586
11831203 (A) a maximum time for the pharmacy to submit records or other documents to
1184-582
1204+587
11851205 the entity following receipt of an audit request for records or documents; and
1186-583
1206+588
11871207 (B) a maximum time for the entity to provide the pharmacy with a preliminary
1188-584
1208+589
11891209 audit report following submission of records under Subsection (6)(a)(i)(A).
1190-585
1210+590
11911211 (ii) The time limits established under Subsections (6)(a)(i)(A) and (B):
1192-586
1212+591
11931213 (A) shall be identical; and
1194-587
1214+592
11951215 (B) may not be less than seven days or more than 60 days.
1196-588
1216+593
11971217 (iii) An entity that audits a pharmacy may not, after the audit completion date,
1198-589
1218+594
11991219 request additional records or other documents from the pharmacy to complete the
1200-590
1220+595
12011221 preliminary audit report described in Subsection (6)(b).
1202-591
1222+596
12031223 (b) An entity that audits a pharmacy shall provide the pharmacy with a preliminary audit
1204-592
1224+597
12051225 report:
1206-593
1226+598
12071227 (i) delivered to the pharmacy or its corporate office of record, within the time limit
1208-594
1228+599
12091229 established under Subsection (6)(a)(i)(B); and
1210-595
1230+600
12111231 (ii) that includes a notation and detailed explanation for each suspected error.
1212-596
1232+601
12131233 (c)(i) Except as provided in Subsection (6)(c)(ii), a pharmacy has 30 days following
1214-597
1234+- 18 - 03-05 15:06 1st Sub. (Green) S.B. 312
1235+602
12151236 receipt of the preliminary audit report to respond to questions, provide additional
1216-598
1237+603
12171238 documentation, and comment on and clarify findings of the audit.
1218-599
1239+604
12191240 (ii) An entity may grant a reasonable extension under Subsection (6)(c)(i) upon
1220-600
1241+605
12211242 request by the pharmacy.
1222-601
1243+606
12231244 (iii) Receipt of the report under Subsection (6)(c)(i) shall be determined by:
1224-602
1245+607
12251246 (A) postmark or other evidence of the date of mailing; or
1226-603
1247+608
12271248 (B) the date of transmission if the report is transmitted electronically.
1228-604
1249+609
12291250 (iv) If a dispute exists between the records of the auditing entity and the pharmacy,
1230-605
1251+610
12311252 the records maintained by the pharmacy shall be presumed valid for the purpose
1232-- 18 - Enrolled Copy S.B. 312
1233-606
1253+611
12341254 of the audit.
1235-607
1255+612
12361256 (7) If an audit results in the dispute or denial of a claim, the entity conducting the audit shall
1237-608
1257+613
12381258 allow any of the following:
1239-609
1259+614
12401260 (a) the pharmacy to resubmit a claim using any commercially reasonable method,
1241-610
1261+615
12421262 including fax, mail, or electronic claims submission within 30 days from the day on
1243-611
1263+616
12441264 which the audit report is received by the pharmacy; or
1245-612
1265+617
12461266 (b) the health benefit plan or other entity that finances or reimburses the cost of health
1247-613
1267+618
12481268 care services or pharmaceutical products to rerun the claim if the health benefit plan
1249-614
1269+619
12501270 or other entity chooses to rerun the claim at no cost to the pharmacy.
1251-615
1271+620
12521272 (8)(a) Within 60 days after the completion of the appeals process under Subsection (9), a
1253-616
1273+621
12541274 final audit report shall be delivered to the pharmacy or its corporate office of record.
1255-617
1275+622
12561276 (b) The final audit report shall include:
1257-618
1277+623
12581278 (i) a disclosure of any money recovered by the entity that conducted the audit; and
1259-619
1279+624
12601280 (ii) legal or contractual information supporting any money recovered, recoupments,
1261-620
1281+625
12621282 or penalties included in the report.
1263-621
1283+626
12641284 (9)(a) An entity that audits a pharmacy shall establish a written appeals process for
1265-622
1285+627
12661286 appealing a preliminary audit report and a final audit report, and shall provide the
1267-623
1287+628
12681288 pharmacy with notice of the written appeals process.
1269-624
1289+629
12701290 (b) If the pharmacy benefit manager's contract or provider manual contains the
1271-625
1291+630
12721292 information required by this Subsection (9), the requirement for notice is met.
1273-626
1293+631
12741294 (10) An auditing entity conducting a pharmacy audit may not:
1275-627
1295+632
12761296 (a) use extrapolation when conducting an audit, including calculating recoupments or
1277-628
1297+633
12781298 penalties for audits, unless otherwise required by federal law or a self-funded
1279-629
1299+634
12801300 insurance plan; or
1281-630
1301+635
12821302 (b) compensate an employee or contractor participating in the audit in a manner that is
1283-631
1303+- 19 - 1st Sub. (Green) S.B. 312 03-05 15:06
1304+636
12841305 based on the amount claimed or the actual amount recouped from the pharmacy being
1285-632
1306+637
12861307 audited.
1287-633
1308+638
12881309 Section 5. Section 58-17b-902 is amended to read:
1289-634
1310+639
12901311 58-17b-902 . Definitions.
1291-635
1312+640
12921313 As used in this part:
1293-636
1314+641
12941315 (1) "Assisted living facility" means the same as that term is defined in Section 26B-2-201.
1295-637
1316+642
12961317 (2) "Cancer drug" means a drug that controls or kills neoplastic cells and includes a drug
1297-638
1318+643
12981319 used in chemotherapy to destroy cancer cells.
1299-639
1320+644
13001321 (3) "Charitable clinic" means a charitable nonprofit corporation that:
1301-- 19 - S.B. 312 Enrolled Copy
1302-640
1322+645
13031323 (a) holds a valid exemption from federal income taxation issued under Section 501(a),
1304-641
1324+646
13051325 Internal Revenue Code;
1306-642
1326+647
13071327 (b) is exempt from federal income taxation under Section 501(c)(3), Internal Revenue
1308-643
1328+648
13091329 Code;
1310-644
1330+649
13111331 (c) provides, on an outpatient basis, for a period of less than 24 consecutive hours, to an
1312-645
1332+650
13131333 individual not residing or confined at a facility owned or operated by the charitable
1314-646
1334+651
13151335 nonprofit corporation:
1316-647
1336+652
13171337 (i) advice;
1318-648
1338+653
13191339 (ii) counseling;
1320-649
1340+654
13211341 (iii) diagnosis;
1322-650
1342+655
13231343 (iv) treatment;
1324-651
1344+656
13251345 (v) surgery; or
1326-652
1346+657
13271347 (vi) care or services relating to the preservation or maintenance of health; and
1328-653
1348+658
13291349 (d) has a licensed outpatient pharmacy.
1330-654
1350+659
13311351 (4) "Charitable pharmacy" means an eligible pharmacy that is operated by a charitable
1332-655
1352+660
13331353 clinic.
1334-656
1354+661
13351355 (5) "County health department" means the same as that term is defined in Section
1336-657
1356+662
13371357 26A-1-102.
1338-658
1358+663
13391359 (6) "Donated prescription drug" means a prescription drug that an eligible donor or
1340-659
1360+664
13411361 individual donates to an eligible pharmacy under the program.
1342-660
1362+665
13431363 (7) "Eligible donor" means a donor that donates a prescription drug from within the state
1344-661
1364+666
13451365 and is:
1346-662
1366+667
13471367 (a) a nursing care facility;
1348-663
1368+668
13491369 (b) an assisted living facility;
1350-664
1370+669
13511371 (c) a licensed intermediate care facility for people with an intellectual disability;
1352-665
1372+- 20 - 03-05 15:06 1st Sub. (Green) S.B. 312
1373+670
13531374 (d) a manufacturer;
1354-666
1375+671
13551376 (e) a pharmaceutical wholesale distributor;
1356-667
1377+672
13571378 (f) an eligible pharmacy; or
1358-668
1379+673
13591380 (g) a physician's office.
1360-669
1381+674
13611382 (8) "Eligible pharmacy" means a pharmacy that:
1362-670
1383+675
13631384 (a) is registered by the division as eligible to participate in the program; and
1364-671
1385+676
13651386 (b)(i) is licensed in the state as a [Class A retail pharmacy] Class A pharmacy or a
1366-672
1387+677
13671388 Class B pharmacy; or
1368-673
1389+678
13691390 (ii) is operated by:
1370-- 20 - Enrolled Copy S.B. 312
1371-674
1391+679
13721392 (A) a county;
1373-675
1393+680
13741394 (B) a county health department;
1375-676
1395+681
13761396 (C) a pharmacy under contract with a county health department;
1377-677
1397+682
13781398 (D) the Department of Health and Human Services created in Section 26B-1-201;
1379-678
1399+683
13801400 or
1381-679
1401+684
13821402 (E) a charitable clinic.
1383-680
1403+685
13841404 (9)(a) "Eligible prescription drug" means a prescription drug, described in Section
1385-681
1405+686
13861406 58-17b-904, that is not:
1387-682
1407+687
13881408 (i) except as provided in Subsection (9)(b), a controlled substance; or
1389-683
1409+688
13901410 (ii) a drug that can only be dispensed to a patient registered with the drug's
1391-684
1411+689
13921412 manufacturer in accordance with federal Food and Drug Administration
1393-685
1413+690
13941414 requirements.
1395-686
1415+691
13961416 (b) "Eligible prescription drug" includes a medication-assisted treatment drug that may
1397-687
1417+692
13981418 be accepted, transferred, and dispensed under the program in accordance with federal
1399-688
1419+693
14001420 law.
1401-689
1421+694
14021422 (10) "Licensed intermediate care facility for people with an intellectual disability" means
1403-690
1423+695
14041424 the same as that term is defined in Section 58-17b-503.
1405-691
1425+696
14061426 (11) "Medically indigent individual" means an individual who:
1407-692
1427+697
14081428 (a)(i) does not have health insurance; and
1409-693
1429+698
14101430 (ii) lacks reasonable means to purchase prescribed medications; or
1411-694
1431+699
14121432 (b)(i) has health insurance; and
1413-695
1433+700
14141434 (ii) lacks reasonable means to pay the insured's portion of the cost of the prescribed
1415-696
1435+701
14161436 medications.
1417-697
1437+702
14181438 (12) "Medication-assisted treatment drug" means buprenorphine prescribed to treat
1419-698
1439+703
14201440 substance use withdrawal symptoms or an opiate use disorder.
1421-699
1441+- 21 - 1st Sub. (Green) S.B. 312 03-05 15:06
1442+704
14221443 (13) "Nursing care facility" means the same as that term is defined in Section 26B-2-201.
1423-700
1444+705
14241445 (14) "Physician's office" means a fixed medical facility that:
1425-701
1446+706
14261447 (a) is staffed by a physician, physician's assistant, nurse practitioner, or registered nurse,
1427-702
1448+707
14281449 licensed under this title; and
1429-703
1450+708
14301451 (b) treats an individual who presents at, or is transported to, the facility.
1431-704
1452+709
14321453 (15) "Program" means the Charitable Prescription Drug Recycling Program created in
1433-705
1454+710
14341455 Section 58-17b-903.
1435-706
1456+711
14361457 (16) "Unit pack" means the same as that term is defined in Section 58-17b-503.
1437-707
1458+712
14381459 (17) "Unlawful conduct" means the same as that term is defined in Sections 58-1-501 and
1439-- 21 - S.B. 312 Enrolled Copy
1440-708
1460+713
14411461 58-17b-501.
1442-709
1462+714
14431463 (18) "Unprofessional conduct" means the same as that term is defined in Sections 58-1-501
1444-710
1464+715
14451465 and 58-17b-502.
1446-711
1466+716
14471467 Section 6. Effective Date.
1448-712
1468+717
14491469 This bill takes effect on May 7, 2025.
14501470 - 22 -