This document includes Senate 3rd Reading Floor Amendments incorporated into the bill on Mon, Mar 2, 2020 at 1:05 PM by lpoole.
This document includes House Committee Amendments incorporated into the bill on Mon, Mar 9, 2020 at 1:52 PM by pflowers.
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7 LONG TITLE
8 General Description:
9 This bill amends provisions relating to the practice of pharmacy.
10 Highlighted Provisions:
11 This bill:
12 ▸ amends definitions;
13 ▸ authorizes the dispensing of epinephrine auto-injectors and stock albuterol under
14 certain circumstances;
15 ▸ authorizes the dispensing of a quantity or dosage form different from a prescription
16 in certain instances;
17 ▸ amends provisions related to the dispensing of a substitute for albuterol;
18 ▸ amends provisions relating to emergency refills;
19 ▸ authorizes the dispensing of certain prescription medical devices without a
20 prescription;
21 ▸ authorizes Ŝ→ [
21a order for an epinephrine
22 auto-injector or stock albuterol in accordance with a protocol that meets certain
23 requirements;
24 ▸ exempts a physician from liability for civil damages for acts or omissions resulting
25 from the dispensing of an epinephrine auto-injector or stock albuterol under the
26 physician's standing prescription drug order;
27 ▸ exempts controlled substances dispensed for administration or use in a health care
28 facility outpatient setting from reporting to the state's controlled substance database;
29 and
30 ▸ makes technical and conforming changes.
31 Money Appropriated in this Bill:
32 None
33 Other Special Clauses:
34 This bill provides a special effective date.
35 Utah Code Sections Affected:
36 AMENDS:
37 26-41-102 (Effective 07/01/20), as last amended by Laws of Utah 2019, Chapter 236
38 26-41-105 (Effective 07/01/20), as last amended by Laws of Utah 2019, Chapter 236
39 58-17b-605, as last amended by Laws of Utah 2013, Chapter 423
40 58-37f-201, as last amended by Laws of Utah 2016, Chapter 99
41 58-37f-203, as last amended by Laws of Utah 2019, Chapter 59
42 ENACTS:
43 58-17b-602.1, Utah Code Annotated 1953
44 58-17b-610.8, Utah Code Annotated 1953
45 58-17b-1001, Utah Code Annotated 1953
46 58-17b-1002, Utah Code Annotated 1953
47 58-17b-1003, Utah Code Annotated 1953
48 58-17b-1004, Utah Code Annotated 1953
49 58-17b-1005, Utah Code Annotated 1953
50 58-17b-1006, Utah Code Annotated 1953
51 58-17b-1007, Utah Code Annotated 1953
52 REPEALS AND REENACTS:
53 58-17b-608, as enacted by Laws of Utah 2004, Chapter 280
54
55 Be it enacted by the Legislature of the state of Utah:
56 Section 1. Section 26-41-102 (Effective 07/01/20) is amended to read:
57 26-41-102 (Effective 07/01/20). Definitions.
58 As used in this chapter:
59 (1) "Anaphylaxis" means a potentially life-threatening hypersensitivity to a substance.
60 (a) Symptoms of anaphylaxis may include shortness of breath, wheezing, difficulty
61 breathing, difficulty talking or swallowing, hives, itching, swelling, shock, or asthma.
62 (b) Causes of anaphylaxis may include insect sting, food allergy, drug reaction, and
63 exercise.
64 (2) "Asthma action plan" means a written plan:
65 (a) developed with a school nurse, a student's parent or guardian, and the student's
66 health care provider to help control the student's asthma; and
67 (b) signed by the student's:
68 (i) parent or guardian; and
69 (ii) health care provider.
70 (3) "Asthma emergency" means an episode of respiratory distress that may include
71 symptoms such as wheezing, shortness of breath, coughing, chest tightness, or breathing
72 difficulty.
73 (4) "Epinephrine auto-injector" means a portable, disposable drug delivery device that
74 contains a measured, single dose of epinephrine that is used to treat a person suffering a
75 potentially fatal anaphylactic reaction.
76 (5) "Health care provider" means an individual who is licensed as:
77 (a) a physician under Title 58, Chapter 67, Utah Medical Practice Act;
78 (b) a physician under Title 58, Chapter 68, Utah Osteopathic Medical Practice Act;
79 (c) an advanced practice registered nurse under Section 58-31b-302; or
80 (d) a physician assistant under Title 58, Chapter 70a, Utah Physician Assistant Act.
81 (6) "Pharmacist" means the same as that term is defined in Section 58-17b-102.
82 (7) "Pharmacy intern" means the same as that term is defined in Section 58-17b-102.
83 (8) "Physician" means the same as that term is defined in Section 58-67-102.
84 [
85 (a) is 18 years of age or older; and
86 (b) (i) for purposes of administering an epinephrine auto-injector, has successfully
87 completed the training program established in Section 26-41-104; and
88 (ii) for purposes of administering stock albuterol, has successfully completed the
89 training program established in Section 26-41-104.1.
90 [
91 (a) means a facility or organization that employs, contracts with, or has a similar
92 relationship with a qualified adult who is likely to have contact with another person who may
93 experience anaphylaxis; and
94 (b) includes:
95 (i) recreation camps;
96 (ii) an education facility, school, or university;
97 (iii) a day care facility;
98 (iv) youth sports leagues;
99 (v) amusement parks;
100 (vi) food establishments;
101 (vii) places of employment; and
102 (viii) recreation areas.
103 [
104 employs, contracts with, or has a similar relationship with a qualified adult who is likely to
105 have contact with another person who may experience an asthma emergency.
106 [
107 (a) used to treat asthma; and
108 (b) that may be delivered through a device, including:
109 (i) an inhaler; or
110 (ii) a nebulizer with a mouthpiece or mask.
111 Section 2. Section 26-41-105 (Effective 07/01/20) is amended to read:
112 26-41-105 (Effective 07/01/20). Authority to obtain and use an epinephrine
113 auto-injector or stock albuterol.
114 (1) A qualified adult who is a teacher or other school employee at a public or private
115 primary or secondary school in the state, or a school nurse, may obtain from the school district
116 physician, the medical director of the local health department, or the local emergency medical
117 services director a prescription for:
118 (a) epinephrine auto-injectors for use in accordance with this chapter; or
119 (b) stock albuterol for use in accordance with this chapter.
120 [
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123 (2) (a) A qualified adult may obtain an epinephrine auto-injector for use in accordance
124 with this chapter that is Ŝ→ [
125 (i) a pharmacist as provided under Section 58-17b-1004; or
126 (ii) a pharmacy intern as provided under Section 58-17b-1004.
127 (b) A qualified adult may obtain stock albuterol for use in accordance with this chapter
128 that is Ŝ→ [
129 (i) a pharmacist as provided under Section 58-17b-1004; or
130 (ii) a pharmacy intern as provided under Section 58-17b-1004.
131 (3) A qualified adult:
132 (a) may immediately administer an epinephrine auto-injector to a person exhibiting
133 potentially life-threatening symptoms of anaphylaxis when a physician is not immediately
134 available; and
135 (b) shall initiate emergency medical services or other appropriate medical follow-up in
136 accordance with the training materials retained under Section 26-41-104 after administering an
137 epinephrine auto-injector.
138 (4) If a school nurse is not immediately available, a qualified adult:
139 (a) may immediately administer stock albuterol to an individual who:
140 (i) has a diagnosis of asthma by a health care provider;
141 (ii) has a current asthma action plan on file with the school; and
142 (iii) is showing symptoms of an asthma emergency as described in the student's asthma
143 action plan; and
144 (b) shall initiate appropriate medical follow-up in accordance with the training
145 materials retained under Section 26-41-104.1 after administering stock albuterol.
146 (5) (a) A qualified entity that complies with Subsection (5)(b) or (c), may obtain [
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149 from a pharmacist under Section 58-17b-1004, or a pharmacy intern under Section
150 58-17b-1004 for:
151 (i) storing:
152 (A) the epinephrine auto-injectors on the qualified epinephrine auto-injector entity's
153 premises; and
154 (B) stock albuterol on the qualified stock albuterol entity's premises; and
155 (ii) use by a qualified adult in accordance with Subsection (3) or (4).
156 (b) A qualified epinephrine auto-injector entity shall:
157 (i) designate an individual to complete an initial and annual refresher training program
158 regarding the proper storage and emergency use of an epinephrine auto-injector available to a
159 qualified adult; and
160 (ii) store epinephrine auto-injectors in accordance with the standards established by the
161 department in Section 26-41-107.
162 (c) A qualified stock albuterol entity shall:
163 (i) designate an individual to complete an initial and annual refresher training program
164 regarding the proper storage and emergency use of stock albuterol available to a qualified
165 adult; and
166 (ii) store stock albuterol in accordance with the standards established by the department
167 in Section 26-41-107.
168 Section 3. Section 58-17b-602.1 is enacted to read:
169 58-17b-602.1. Dispensing quantity or dosage form different from prescription.
170 (1) Without specific authorization from a prescriber, a pharmacist or pharmacy intern
171 may dispense:
172 (a) a prescription in a quantity different than the quantity prescribed if the prescribed
173 quantity or package size is not commercially available; and
174 (b) a prescription in a dosage form different than the dosage form prescribed Ŝ→ , ←Ŝ if in
174a the
175 professional judgement of the pharmacist or pharmacy intern Ŝ→ , ←Ŝ dispensing a different
175a dosage
176 form is in the best interest of the patient.
177 (2) This section does not apply if:
178 (a) the substitute would change the bioavailability of the medication;
179 (b) the substitute would change the treatment parameters; or
180 (c) the prescriber has written or clearly designated "dispense as written" on the
181 prescription.
182 Section 4. Section 58-17b-605 is amended to read:
183 58-17b-605. Drug product equivalents.
184 (1) For the purposes of this section:
185 (a) (i) "Drug" is as defined in Section 58-17b-102.
186 (ii) "Drug" does not mean a "biological product" as defined in Section 58-17b-605.5.
187 (b) "Drug product equivalent" means:
188 (i) a drug product that is designated as the therapeutic equivalent of another drug
189 product in the Approved Drug Products with Therapeutic Equivalence Evaluations prepared by
190 the Center for Drug Evaluation and Research of the United States Food and Drug
191 Administration[
192 (ii) notwithstanding Subsection (1)(b)(i), an appropriate substitute for albuterol
193 designated by division rule made under Subsection (9).
194 (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug
195 by brand or proprietary name may substitute a drug product equivalent for the prescribed drug
196 only if:
197 (a) the purchaser specifically requests or consents to the substitution of a drug product
198 equivalent;
199 (b) the drug product equivalent is of the same generic type and is designated the
200 therapeutic equivalent in the approved drug products with therapeutic equivalence evaluations
201 prepared by the Center for Drug Evaluation and Research of the Federal Food and Drug
202 Administration;
203 (c) the drug product equivalent is permitted to move in interstate commerce;
204 (d) the pharmacist or pharmacy intern counsels the patient on the use and the expected
205 response to the prescribed drug, whether a substitute or not, and the substitution is not
206 otherwise prohibited by this chapter;
207 (e) the prescribing practitioner has not indicated that a drug product equivalent may not
208 be substituted for the drug, as provided in Subsection (6); and
209 (f) the substitution is not otherwise prohibited by law.
210 (3) (a) Each out-of-state mail service pharmacy dispensing a drug product equivalent as
211 a substitute for another drug into this state shall notify the patient of the substitution either by
212 telephone or in writing.
213 (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
214 chapter with respect to a drug product equivalent substituted for another drug, including
215 labeling and record keeping.
216 (4) Pharmacists or pharmacy interns may not substitute without the prescriber's
217 authorization on trade name drug product prescriptions unless the product is currently
218 categorized in the approved drug products with therapeutic equivalence evaluations prepared
219 by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration
220 as a drug product considered to be therapeutically equivalent to another drug product.
221 (5) A pharmacist or pharmacy intern who dispenses a prescription with a drug product
222 equivalent under this section assumes no greater liability than would be incurred had the
223 pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
224 (6) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of the
225 patient that a drug product equivalent not be substituted for a prescribed drug, the practitioner
226 may indicate a prohibition on substitution either by writing "dispense as written" or signing in
227 the appropriate space where two lines have been preprinted on a prescription order and
228 captioned "dispense as written" or "substitution permitted".
229 (b) If the prescription is communicated orally by the prescribing practitioner to the
230 pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution
231 and that indication shall be noted in writing by the pharmacist or pharmacy intern with the
232 name of the practitioner and the words "orally by" and the initials of the pharmacist or
233 pharmacy intern written after it.
234 (7) A pharmacist or pharmacy intern who substitutes a drug product equivalent for a
235 prescribed drug shall communicate the substitution to the purchaser. The drug product
236 equivalent container shall be labeled with the name of the drug dispensed, and the pharmacist,
237 pharmacy intern, or pharmacy technician shall indicate on the file copy of the prescription both
238 the name of the prescribed drug and the name of the drug product equivalent dispensed in its
239 place.
240 (8) (a) For purposes of this Subsection (8), "substitutes" means to substitute:
241 (i) a generic drug for another generic drug;
242 (ii) a generic drug for a nongeneric drug;
243 (iii) a nongeneric drug for another nongeneric drug; or
244 (iv) a nongeneric drug for a generic drug.
245 (b) A prescribing practitioner who makes a finding under Subsection (6)(a) for a
246 patient with a seizure disorder shall indicate a prohibition on substitution of a drug product
247 equivalent in the manner provided in Subsection (6)(a) or (b).
248 (c) Except as provided in Subsection (8)(d), a pharmacist or pharmacy intern who
249 cannot dispense the prescribed drug as written, and who needs to substitute a drug product
250 equivalent for the drug prescribed to the patient to treat or prevent seizures shall notify the
251 prescribing practitioner prior to the substitution.
252 (d) Notification under Subsection (8)(c) is not required if the drug product equivalent is
253 paid for in whole or in part by Medicaid.
254 (9) (a) The division shall designate by rule made in accordance with Title 63G, Chapter
255 3, Utah Administrative Rulemaking Act, and in consultation with the board, the Physicians
256 Licensing Board created in Section 58-67-201, and the Osteopathic Physician and Surgeon's
257 Licensing Board created in Section 58-68-201, appropriate substitutes for albuterol.
258 (b) Subsections (2)(b) and (4) do not apply to the substitution of a drug product
259 equivalent for albuterol.
260 [
261 authorized does not constitute evidence of negligence.
262 Section 5. Section 58-17b-608 is repealed and reenacted to read:
263 58-17b-608. Emergency refills.
264 (1) If a prescription may not Ŝ→ [
264a pharmacist or pharmacy intern
265 may refill the prescription in an emergency without the prescribing practitioner's authorization
266 if:
267 (a) the prescription is for a drug that is not a controlled substance;
268 (b) the patient is currently using the drug prescribed;
269 (c) the prescribing practitioner is not available promptly to authorize the refill;
270 (d) the pharmacist or pharmacy intern, or another pharmacist or pharmacy Ŝ→ [
270a intern ←Ŝ at the
271 same pharmacy, has not previously dispensed a refill for the prescription under this section;
272 (e) refilling the prescription is in the interest of the patient's health;
273 (f) in the professional judgment of the pharmacist or pharmacy intern the prescription
274 should be refilled;
275 (g) except as provided in Subsection (1)(h), the pharmacist or pharmacy intern
276 dispenses the medication in accordance with the prescribing practitioner's instructions included
277 with the prescription; and
278 (h) the pharmacist or pharmacy intern dispenses no more than the amount necessary to
279 address the emergency.
280 (2) If the prescription for a drug dispensed under Subsection (1) is on file with the
281 pharmacy where the drug is dispensed, the pharmacist or pharmacy intern may dispense more
282 than a three-day supply only if:
283 (a) (i) the prescription has expired within the past 30 days; or
284 (ii) no refills are remaining on the prescription; and
285 (b) the amount dispensed does not exceed the lesser of:
286 (i) a 30-day supply; or
287 (ii) the quantity last dispensed at the pharmacy pursuant to the prescription as either a
288 fill or a refill Ŝ→ [
289 (3) A pharmacist or pharmacy intern who dispenses a prescription refill under this
290 section shall inform the prescribing practitioner of the emergency refill as soon as practicable.
291 Section 6. Section 58-17b-610.8 is enacted to read:
292 58-17b-610.8. Prescription devices.
293 Ĥ→ [
294 described in Subsection (2) to a patient if:
295 (a) the patient has a current diagnosis, prescription, or treatment protocol from a
296 prescribing practitioner for which one or more of the devices described in Subsection (2) is
297 indicated; and
298 (b) the pharmacist or pharmacy intern acts in accordance with rules made by the
299 division under Subsection (3).
300 (2) This section applies to:
301 (a) nebulizers;
302 (b) spacers for use with nebulizers or inhalers; and
303 (c) diabetic testing supplies.
304 (3) The division shall make rules in accordance with Title 63G, Chapter 3, Utah
305 Ĥ→ [
306 Board created in Section 58-67-201, and the Osteopathic Physician and Surgeon's Licensing
307 Board created in Section 58-68-201, to implement this section.
307a (1) Any of the following documents from a prescribing practitioner shall be considered
307b a prescription for purposes of the dispensing of and payment for a device described in
307c Subsection (3), if the device is prescribed or indicated by the document and the document is on
307d file with a pharmacy:
307e (a) a written prescription; or
307f (b) a written record of a patient's:
307g (i) current diagnosis; or
307h (ii) treatment protocol.
307i (2) A pharmacist or pharmacy intern at a pharmacy at which a document considered a
307j prescription in Subsection (1) is on file may dispense a prescription device described in
307k Subsection (3) to the patient in accordance with:
307l (a) the document; and
307m (b) rules made by the division under Subsection (4).
307n (3) This section applies to:
307o (a) nebulizers;
307p (b) spacers for use with nebulizers or inhalers; and
307q (c) diabetic testing supplies.
307r (4) The division shall make rules in accordance with Title 63G, Chapter 3, Utah
307s Administrative Rulemaking Act, and in consultation with the board, the Physicians Licensing
307t Board created in Section 58-67-201, and the Osteopathic Physician and Surgeon's Licensing
307u Board created in Section 58-68-201, to implement this section. ←Ĥ
308 Section 7. Section 58-17b-1001 is enacted to read:
309
310 58-17b-1001. Title.
311 This part is known as the "Epinephrine Auto-Injector and Stock Albuterol Act."
312 Section 8. Section 58-17b-1002 is enacted to read:
313 58-17b-1002. Definitions.
314 As used in this part:
315 (1) "Epinephrine auto-injector" means the same as that term is defined in Section
316 26-41-102.
317 (2) "Local health department" means the same as that term is defined in Section☆
318 ☆26A-1-102.
319 (3) "Physician" means the same as that term is defined in Section 58-10-102.
320 (4) "Qualified adult" means the same as that term is defined in Section 26-41-102.
321 (5) "Qualified epinephrine auto-injector entity" means the same as that term is defined
322 in Section 26-41-102.
323 (6) "Qualified stock albuterol entity" means the same as that term is defined in Section
324 26-41-102.
325 (7) "Stock albuterol" means the same as that term is defined in Section 26-41-102.
326 Section 9. Section 58-17b-1003 is enacted to read:
327 58-17b-1003. Voluntary participation.
328 This part does not create a duty or standard of care for a person to prescribe or dispense
329 an epinephrine auto-injector or stock albuterol.
330 Section 10. Section 58-17b-1004 is enacted to read:
331 58-17b-1004. Authorization to dispense an epinephrine auto-injector and stock
332 albuterol pursuant to a standing order.
333 (1) Notwithstanding any other provision of this chapter, a pharmacist or pharmacy
334 intern may dispense an epinephrine auto-injector:
335 (a) (i) to a qualified adult for use in accordance with Title 26, Chapter 41, Emergency
336 Response for Life-threatening Conditions; or
337 (ii) to a qualified epinephrine auto-injector entity for use in accordance with Title 26,
338 Chapter 41, Emergency Response for Life-threatening Conditions;
339 (b) pursuant to a standing prescription drug order made in accordance with Section
340 58-17b-1005;
341 (c) without any other prescription drug order from a person licensed to prescribe an
342 epinephrine auto-injector; and
343 (d) in accordance with the dispensing guidelines in Section 58-17b-1006.
344 (2) Notwithstanding any other provision of this chapter, a pharmacist or pharmacist
345 intern may dispense stock albuterol:
346 (a) (i) to a qualified adult for use in accordance with Title 26, Chapter 41, Emergency
347 Response for Life-threatening Conditions; or
348 (ii) to a qualified stock albuterol entity for use in accordance with Title 26, Chapter 41,
349 Emergency Response for Life-threatening Conditions;
350 (b) pursuant to a standing prescription drug order made in accordance with Section
351 58-17b-1005;
352 (c) without any other prescription drug order from a person licensed to prescribe stock
353 albuterol; and
354 (d) in accordance with the dispensing guidelines in Section 58-17b-1006.
355 Section 11. Section 58-17b-1005 is enacted to read:
356 58-17b-1005. Standing prescription drug orders for epinephrine auto-injectors
357 and stock albuterol.
358 (1) A physician acting in the physician's capacity as an employee of the Department of
359 Health or as a medical director of a local health department may issue a standing prescription
360 drug order authorizing the dispensing of Ŝ→ [
361 58-17b-1004 in accordance with a protocol that:
362 (a) requires the physician to specify the persons, by professional license number,
363 authorized to dispense the epinephrine auto-injector;
364 (b) requires the physician to review at least annually the dispensing practices of those
365 authorized by the physician to dispense the epinephrine auto-injector;
366 (c) requires those authorized by the physician to dispense the epinephrine auto-injector
367 to make and retain a record of each dispensing, including:
368 (i) the name of the qualified adult Ŝ→ [
368a Ŝ→ [
369 individual 18 years old or older
370 (ii) a description of the epinephrine auto-injector dispensed; and
371 (iii) other relevant information; and
372 (d) is approved by the division by administrative rule made in accordance with Title
373 63G, Chapter 3, Utah Administrative Rulemaking Act, in collaboration with the Physicians
374 Licensing Board created in Section 58-67-201 and the Board of Pharmacy.
375 (2) A physician acting in the physician's capacity as an employee of the Department of
376 Health or as a medical director of a local health department may issue a standing prescription
377 drug order authorizing the dispensing of the stock albuterol under Section 58-17b-1004 in
378 accordance with a protocol that:
379 (a) requires the physician to specify the persons, by professional license number,
380 authorized to dispense the stock albuterol;
381 (b) requires the physician to review at least annually the dispensing practices of those
382 authorized by the physician to dispense the stock albuterol;
383 (c) requires those authorized by the physician to dispense the stock albuterol to make
384 and retain a record of each dispensing, including:
385 (i) the name of the qualified adult Ŝ→ [
385a
386 years old or older
387 (ii) a description of the stock albuterol dispensed; and
388 (iii) other relevant information; and
389 (d) is approved by the division by administrative rule made in accordance with Title
390 63G, Chapter 3, Utah Administrative Rulemaking Act, in collaboration with the Physicians
391 Licensing Board created in Section 58-67-201 and the board.
392 Section 12. Section 58-17b-1006 is enacted to read:
393 58-17b-1006. Guidelines for dispensing an epinephrine auto-injector and stock
394 albuterol.
395 (1) A pharmacist or pharmacy intern who dispenses an epinephrine auto-injector under
396 this part shall, at a minimum, provide patient counseling to the qualified adult Ŝ→ [
396a qualified
397 epinephrine auto-injector entity Ŝ→ [
397a epinephrine
398 auto-injector is dispensed regarding:
399 (a) the appropriate administration and storage of the epinephrine auto-injector;
400 (b) potential side effects and risks of the epinephrine auto-injector; and
401 (c) when to seek emergency medical attention.
402 (2) A pharmacist or pharmacy intern who dispenses stock albuterol under this part
403 shall, at a minimum, provide patient counseling to the qualified adult Ŝ→ [
403a albuterol
404 entity Ŝ→ [
404a regarding:
405 (a) the appropriate administration and storage of the stock albuterol;
406 (b) potential side effects and risks of the stock albuterol; and
407 (c) when to seek emergency medical attention.
408 Section 13. Section 58-17b-1007 is enacted to read:
409 58-17b-1007. Limited civil liability.
410 (1) A physician who issues a standing prescription drug order in accordance with
411 Subsection 58-17b-1005(1) is not liable for any civil damages for acts or omissions resulting
412 from the dispensing of an epinephrine auto-injector under this part.
413 (2) A physician who issues a standing prescription drug order in accordance with
414 Subsection 58-17b-1005(2) is not liable for any civil damages for acts or omissions resulting
415 from the dispensing of stock albuterol under this part.
416 Section 14. Section 58-37f-201 is amended to read:
417 58-37f-201. Controlled substance database -- Creation -- Purpose.
418 (1) There is created within the division a controlled substance database.
419 (2) The division shall administer and direct the functioning of the database in
420 accordance with this chapter.
421 (3) The division may, under state procurement laws, contract with another state agency
422 or a private entity to establish, operate, or maintain the database.
423 (4) The division shall, in collaboration with the board, determine whether to operate
424 the database within the division or contract with another entity to operate the database, based
425 on an analysis of costs and benefits.
426 (5) The purpose of the database is to contain:
427 (a) the data described in Section 58-37f-203 regarding [
428
429
430 (b) data reported to the division under Section 26-21-26 regarding poisoning or
431 overdose;
432 (c) data reported to the division under Subsection 41-6a-502(4) or 41-6a-502.5(5)(b)
433 regarding convictions for driving under the influence of a prescribed controlled substance or
434 impaired driving; and
435 (d) data reported to the division under Subsection 58-37-8(1)(e) or 58-37-8(2)(j)
436 regarding certain violations of the Utah Controlled Substances Act.
437 (6) The division shall maintain the database in an electronic file or by other means
438 established by the division to facilitate use of the database for identification of:
439 (a) prescribing practices and patterns of prescribing and dispensing controlled
440 substances;
441 (b) practitioners prescribing controlled substances in an unprofessional or unlawful
442 manner;
443 (c) individuals receiving prescriptions for controlled substances from licensed
444 practitioners, and who subsequently obtain dispensed controlled substances from a drug outlet
445 in quantities or with a frequency inconsistent with generally recognized standards of dosage for
446 that controlled substance;
447 (d) individuals presenting forged or otherwise false or altered prescriptions for
448 controlled substances to a pharmacy;
449 (e) individuals admitted to a general acute hospital for poisoning or overdose involving
450 a prescribed controlled substance; and
451 (f) individuals convicted for:
452 (i) driving under the influence of a prescribed controlled substance that renders the
453 individual incapable of safely operating a vehicle;
454 (ii) driving while impaired, in whole or in part, by a prescribed controlled substance; or
455 (iii) certain violations of the Utah Controlled Substances Act.
456 Section 15. Section 58-37f-203 is amended to read:
457 58-37f-203. Submission, collection, and maintenance of data.
458 (1) (a) The division shall implement on a statewide basis, including non-resident
459 pharmacies as defined in Section 58-17b-102, the following two options for a pharmacist to
460 submit information:
461 (i) real-time submission of the information required to be submitted under this part to
462 the controlled substance database; and
463 (ii) 24-hour daily or next business day, whichever is later, batch submission of the
464 information required to be submitted under this part to the controlled substance database.
465 (b) (i) On and after January 1, 2016, a pharmacist shall comply with either:
466 (A) the submission time requirements established by the division under Subsection
467 (1)(a)(i); or
468 (B) the submission time requirements established by the division under Subsection
469 (1)(a)(ii).
470 (ii) Prior to January 1, 2016, a pharmacist may submit information using either option
471 under this Subsection (1).
472 (c) The division shall comply with Title 63G, Chapter 6a, Utah Procurement Code.
473 (2) (a) The pharmacist-in-charge and the pharmacist of the drug outlet where a
474 controlled substance is dispensed shall submit the data described in this section to the division
475 in accordance with:
476 (i) the requirements of this section;
477 (ii) the procedures established by the division;
478 (iii) additional types of information or data fields established by the division; and
479 (iv) the format established by the division.
480 (b) A dispensing medical practitioner licensed under Chapter 17b, Part 8, Dispensing
481 Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, shall comply with
482 the provisions of this section and the dispensing medical practitioner shall assume the duties of
483 the pharmacist under this chapter.
484 (3) (a) [
485 pharmacist described in Subsection (2)(b) shall, for each controlled substance dispensed by a
486 pharmacist under the pharmacist's supervision [
487
488 the division by rule in accordance with Subsection (6) regarding:
489 (i) each controlled substance that is dispensed by the pharmacist or under the
490 pharmacist's supervision; and
491 (ii) each noncontrolled substance that is:
492 (A) designated by the division under Subsection (8)(a); and
493 (B) dispensed by the pharmacist or under the pharmacist's supervision.
494 (b) Subsection (3)(a) does not apply to a drug that is dispensed for [
495 administration to, or use by, a patient at a health care facility, including a patient in an
496 outpatient setting at the health care facility.
497 (4) An individual whose records are in the database may obtain those records upon
498 submission of a written request to the division.
499 (5) (a) A patient whose record is in the database may contact the division in writing to
500 request correction of any of the patient's database information that is incorrect. The patient
501 shall provide a postal address for the division's response.
502 (b) The division shall grant or deny the request within 30 days from receipt of the
503 request and shall advise the requesting patient of its decision by mail postmarked within 35
504 days of receipt of the request.
505 (c) If the division denies a request under this Subsection (5) or does not respond within
506 35 days, the patient may submit an appeal to the Department of Commerce, within 60 days
507 after the postmark date of the patient's letter making a request for a correction under this
508 Subsection (5).
509 (6) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
510 Administrative Rulemaking Act, to establish submission requirements under this part,
511 including:
512 (a) electronic format;
513 (b) submission procedures; and
514 (c) required information and data fields.
515 (7) The division shall ensure that the database system records and maintains for
516 reference:
517 (a) the identification of each individual who requests or receives information from the
518 database;
519 (b) the information provided to each individual; and
520 (c) the date and time that the information is requested or provided.
521 (8) (a) The division, in collaboration with the Utah Controlled Substance Advisory
522 Committee created in Section 58-38a-201, shall designate a list of noncontrolled substances
523 described in Subsection (8)(b) by rule made in accordance with Title 63G, Chapter 3, Utah
524 Administrative Rulemaking Act.
525 (b) To determine whether a prescription drug should be designated in the schedules of
526 controlled substances under this chapter, the division may collect information about a
527 prescription drug as defined in Section 58-17b-102 that is not designated in the schedules of
528 controlled substances under this chapter.
529 Section 16. Effective date.
530 (1) Except as provided in Subsection (2), this bill takes effect on May 12, 2020.
531 (2) The actions affecting the following sections take effect on July 1, 2020:
532 (a) Section 26-41-102;
533 (b) Section 26-41-105;
534 (c) Section 58-17b-1001;
535 (d) Section 58-17b-1002;
536 (e) Section 58-17b-1003;
537 (f) Section 58-17b-1004;
538 (g) Section 58-17b-1005;
539 (h) Section 58-17b-1006; and
540 (i) Section 58-17b-1007.