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8 LONG TITLE
9 General Description:
10 This bill creates a program that allows certain pharmacies to accept and dispense
11 donated unused prescription medications to certain individuals.
12 Highlighted Provisions:
13 This bill:
14 ▸ amends the Pharmacy Practice Act;
15 ▸ defines terms;
16 ▸ directs the Division of Occupational and Professional Licensing (DOPL) to make
17 rules, in consultation with the Utah State Board of Pharmacy, to create a charitable
18 prescription drug recycling program;
19 ▸ establishes criteria for prescription drugs eligible for the program;
20 ▸ establishes requirements for donors and pharmacies;
21 ▸ limits the liability of program participants and drug manufacturers;
22 ▸ directs DOPL to make rules establishing certain requirements, standards,
23 procedures, and processes; and
24 ▸ makes technical changes.
25 Money Appropriated in this Bill:
26 None
27 Other Special Clauses:
28 None
29 Utah Code Sections Affected:
30 AMENDS:
31 58-17b-502, as last amended by Laws of Utah 2015, Chapter 336
32 58-17b-503, as last amended by Laws of Utah 2011, Chapter 366
33 ENACTS:
34 58-17b-901, Utah Code Annotated 1953
35 58-17b-902, Utah Code Annotated 1953
36 58-17b-903, Utah Code Annotated 1953
37 58-17b-904, Utah Code Annotated 1953
38 58-17b-905, Utah Code Annotated 1953
39 58-17b-906, Utah Code Annotated 1953
40 58-17b-907, Utah Code Annotated 1953
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42 Be it enacted by the Legislature of the state of Utah:
43 Section 1. Section 58-17b-502 is amended to read:
44 58-17b-502. Unprofessional conduct.
45 "Unprofessional conduct" includes:
46 (1) willfully deceiving or attempting to deceive the division, the board, or their agents
47 as to any relevant matter regarding compliance under this chapter;
48 (2) (a) except as provided in Subsection (2)(b):
49 (i) paying or offering rebates to practitioners or any other health care providers, or
50 receiving or soliciting rebates from practitioners or any other health care provider; or
51 (ii) paying, offering, receiving, or soliciting compensation in the form of a commission,
52 bonus, rebate, kickback, or split fee arrangement with practitioners or any other health care
53 provider, for the purpose of obtaining referrals.
54 (b) Subsection (2)(a) does not apply to:
55 (i) giving or receiving price discounts based on purchase volume;
56 (ii) passing along pharmaceutical manufacturer's rebates; or
57 (iii) providing compensation for services to a veterinarian.
58 (3) misbranding or adulteration of any drug or device or the sale, distribution, or
59 dispensing of any outdated, misbranded, or adulterated drug or device;
60 (4) engaging in the sale or purchase of drugs or devices that are samples or packages
61 bearing the inscription "sample" or "not for resale" or similar words or phrases;
62 (5) except as provided in Section 58-17b-503 or Part 9, Charitable Prescription Drug
63 Recycling Act, accepting back and redistributing [
64 has left the premises of any pharmacy, unless the drug is in a unit pack, as defined in Section
65 58-17b-503, or the manufacturer's sealed container, as defined in rule;
66 (6) an act in violation of this chapter committed by a person for any form of
67 compensation if the act is incidental to the person's professional activities, including the
68 activities of a pharmacist, pharmacy intern, or pharmacy technician;
69 (7) violating Federal Title II, P.L. 91, Controlled Substances Act, Title 58, Chapter 37,
70 Utah Controlled Substances Act, or rules or regulations adopted under either act;
71 (8) requiring or permitting pharmacy interns or technicians to engage in activities
72 outside the scope of practice for their respective license classifications, as defined in this
73 chapter and division rules made in collaboration with the board, or beyond their scope of
74 training and ability;
75 (9) administering:
76 (a) without appropriate training, as defined by rule;
77 (b) without a physician's order, when one is required by law; and
78 (c) in conflict with a practitioner's written guidelines or written protocol for
79 administering;
80 (10) disclosing confidential patient information in violation of the provisions of the
81 Health Insurance Portability and Accountability Act of 1996 or other applicable law;
82 (11) engaging in the practice of pharmacy without a licensed pharmacist designated as
83 the pharmacist-in-charge;
84 (12) failing to report to the division any adverse action taken by another licensing
85 jurisdiction, government agency, law enforcement agency, or court for conduct that in
86 substance would be considered unprofessional conduct under this section; and
87 (13) as a pharmacist or pharmacy intern, compounding a prescription drug in a dosage
88 form which is regularly and commonly available from a manufacturer in quantities and
89 strengths prescribed by a practitioner.
90 Section 2. Section 58-17b-503 is amended to read:
91 58-17b-503. Exception to unprofessional conduct.
92 (1) For purposes of this section:
93 (a) "Licensed intermediate care facility for people with an intellectual disability" means
94 an intermediate care facility for people with an intellectual disability that is licensed as a
95 nursing care facility or a small health care facility under Title 26, Chapter 21, Health Care
96 Facility Licensing and Inspection Act.
97 (b) "Nursing care facility" [
98 defined in Section 26-21-2.
99 (c) "Unit pack" means a tamper-resistant nonreusable single-dose single-drug package
100 with identification that indicates the lot number and expiration date for the drug.
101 (2) [
102 may:
103 (a) accept and redistribute an unused drug under Part 9, Charitable Prescription Drug
104 Recycling Act; or
105 (b) accept back and redistribute any unused drug, or a part of it, after it has left the
106 premises of the pharmacy if:
107 [
108 intermediate care facility for people with an intellectual disability, or state prison facility,
109 county jail, or state hospital;
110 [
111 according to manufacturer recommendations;
112 [
113 [
114 [
115 intern; and
116 [
117 federal Food and Drug Administration and Drug Enforcement Administration regulations.
118 Section 3. Section 58-17b-901 is enacted to read:
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120 58-17b-901. Title.
121 This part is known as the "Charitable Prescription Drug Recycling Act."
122 Section 4. Section 58-17b-902 is enacted to read:
123 58-17b-902. Definitions.
124 As used in this part:
125 (1) "Assisted living facility" means the same as that term is defined in Section 26-21-2.
126 (2) "Cancer drug" means a drug that controls or kills neoplastic cells and includes a
127 drug used in chemotherapy to destroy cancer cells.
128 (3) "Charitable clinic" means a charitable nonprofit corporation that:
129 (a) holds a valid exemption from federal income taxation issued under Section 501(a),
130 Internal Revenue Code;
131 (b) is exempt from federal income taxation under Section 501(c)(3), Internal Revenue
132 Code;
133 (c) provides, on an outpatient basis, for a period of less than 24 consecutive hours, to
134 an individual not residing or confined at a facility owned or operated by the charitable
135 nonprofit corporation:
136 (i) advice;
137 (ii) counseling;
138 (iii) diagnosis;
139 (iv) treatment;
140 (v) surgery; or
141 (vi) care or services relating to the preservation or maintenance of health; and
142 (d) has a licensed outpatient pharmacy.
143 (4) "Charitable pharmacy" means an eligible pharmacy that is operated by a charitable
144 clinic.
145 (5) "County health department" means the same as that term is defined in Section
146 26A-1-102.
147 (6) "Donated prescription drug" means a prescription drug that an eligible donor
148 donates to an eligible pharmacy under the program.
149 (7) "Eligible donor" means a donor that donates a prescription drug from within the
150 state and is:
151 (a) a nursing care facility;
152 (b) an assisted living facility;
153 (c) a licensed intermediate care facility for people with an intellectual disability;
154 (d) a manufacturer;
155 (e) a pharmaceutical wholesale distributor;
156 (f) an eligible pharmacy; or
157 (g) a physician's office.
158 (8) "Eligible pharmacy" means a pharmacy that:
159 (a) is registered by the division as eligible to participate in the program; and
160 (b) is operated by:
161 (i) a county;
162 (ii) a county health department;
163 (iii) a pharmacy under contract with a county health department;
164 (iv) the Department of Health, created in Section 26-1-4;
165 (v) the Division of Substance Abuse and Mental Health, created in Section
166 62A-15-103; or
167 (vi) a charitable clinic.
168 (9) "Eligible prescription drug" means a prescription drug, described in Section
169 58-17b-904, that is not:
170 (a) a controlled substance; or
171 (b) a drug that can only be dispensed to a patient registered with the drug's
172 manufacturer in accordance with federal Food and Drug Administration requirements.
173 (10) "Licensed intermediate care facility for people with an intellectual disability"
174 means the same as that term is defined in Section 58-17b-503.
175 (11) "Medically indigent individual" means an individual who:
176 (a) (i) does not have health insurance; and
177 (ii) lacks reasonable means to purchase prescribed medications; or
178 (b) (i) is covered under Medicaid or Medicare; and
179 (ii) lacks reasonable means to pay the insured's portion of the cost of the prescribed
180 medications.
181 (12) "Nursing care facility" means the same as that term is defined in Section
182 26-18-501.
183 (13) "Physician's office" means a fixed medical facility that:
184 (a) is staffed by a physician, physician's assistant, nurse practitioner, or registered
185 nurse, licensed under Title 58, Occupations and Professions; and
186 (b) treats an individual who presents at, or is transported to, the facility.
187 (14) "Program" means the Charitable Prescription Drug Recycling Program created in
188 Section 58-17b-903.
189 (15) "Unit pack" means the same as that term is defined in Section 58-17b-503.
190 (16) "Unlawful conduct" means the same as that term is defined in Sections 58-1-501
191 and 58-17b-501.
192 (17) "Unprofessional conduct" means the same as that term is defined in Sections
193 58-1-501 and 58-17b-502.
194 Section 5. Section 58-17b-903 is enacted to read:
195 58-17b-903. Charitable Prescription Drug Recycling Program -- Creation --
196 Requirements.
197 (1) There is created the Charitable Prescription Drug Recycling Program.
198 (2) The division, in consultation with the board, shall:
199 (a) implement the program, on a statewide basis, to permit an eligible donor to transfer
200 an eligible prescription drug to an eligible pharmacy for dispensing to a medically indigent
201 individual;
202 (b) in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act,
203 make rules necessary to implement the program; and
204 (c) provide technical assistance to entities that desire to participate in the program.
205 Section 6. Section 58-17b-904 is enacted to read:
206 58-17b-904. Criteria for eligible prescription drugs.
207 An eligible pharmacy may not accept or dispense an unused prescription drug under the
208 program unless the unused prescription drug:
209 (1) (a) is in a unit pack or the manufacturer's sealed container; or
210 (b) is an injectable medication;
211 (2) (a) is unopened; or
212 (b) is a cancer drug packaged in an unopened single-unit dose that has been removed
213 from a multi-dose package;
214 (3) is accepted and dispensed by the eligible pharmacy before:
215 (a) a beyond use date that appears on the label;
216 (b) the expiration date recommended by the manufacturer; or
217 (c) a date, established by division rule for a specific prescription drug, in accordance
218 with Title 63G, Chapter 3, Utah Administrative Rulemaking Act, that is later than the date in
219 Subsection (3)(a) or (3)(b);
220 (4) (a) is not adulterated or mislabeled; and
221 (b) the pharmacist or licensed pharmacist technician accepting or dispensing the
222 prescription drug does not have reason to believe that the prescription drug is adulterated or
223 mislabeled.
224 Section 7. Section 58-17b-905 is enacted to read:
225 58-17b-905. Participation in program -- Requirements -- Fees.
226 (1) An eligible donor or an eligible pharmacy may participate in the program.
227 (2) An eligible pharmacy:
228 (a) shall comply with all applicable federal and state laws related to the storage and
229 distribution of a prescription drug;
230 (b) shall comply with all applicable federal and state laws related to the acceptance and
231 transfer of a prescription drug, including 21 U.S.C. Chapter 9, Subchapter V, Part H,
232 Pharmaceutical Distribution Supply Chain;
233 (c) shall, before accepting or dispensing a prescription drug under the program, inspect
234 each prescription drug to determine whether the prescription drug is an eligible prescription
235 drug;
236 (d) may dispense an eligible prescription drug to a medically indigent individual who:
237 (i) is a resident of the state; and
238 (ii) has a prescription issued by a practitioner;
239 (e) may charge a handling fee, adopted by the division under Section 63J-1-504; and
240 (f) may not accept, transfer, or dispense a prescription drug in violation of the federal
241 Food, Drug, and Cosmetic Act, 21 U.S.C. Sec. 301 et seq.
242 Section 8. Section 58-17b-906 is enacted to read:
243 58-17b-906. Liability of participating organizations and manufacturers.
244 In the absence of bad faith or gross negligence, a person is not criminally or civilly
245 liable for injury, death, or loss of property based solely on the fact that the person
246 manufactured, provided, donated, accepted, or dispensed an eligible prescription drug under
247 this part.
248 Section 9. Section 58-17b-907 is enacted to read:
249 58-17b-907. Rules made by the division.
250 The rules made by the division under Subsection 58-17b-903(2)(b) shall include:
251 (1) registration requirements to establish the eligibility of a pharmacy to participate in
252 the program;
253 (2) a formulary that includes all eligible prescription drugs approved by the federal
254 Food and Drug Administration;
255 (3) standards and procedures for:
256 (a) verifying whether a pharmacy or pharmacist participating in the program is licensed
257 and in good standing with the board;
258 (b) handling of a donated eligible prescription drug, including:
259 (i) acceptance;
260 (ii) identification, including redundant criteria for verification;
261 (iii) documentation, under 21 U.S.C. Sec. 360eee-1, of transaction information, history,
262 and statements;
263 (iv) safe storage;
264 (v) security;
265 (vi) inspection;
266 (vii) transfer; and
267 (viii) dispensing;
268 (c) a pharmacist or licensed pharmacy technician working in or consulting with a
269 participating eligible donor;
270 (d) disposition of a donated prescription drug that is a controlled substance;
271 (e) record keeping regarding:
272 (i) the eligible donor that donated each prescription drug;
273 (ii) the identification and evaluation of a donated prescription drug by a pharmacist or
274 licensed pharmacy technician; and
275 (iii) the dispensing or disposition of a prescription drug;
276 (f) determining the status of a medically indigent individual;
277 (g) labeling requirements to:
278 (i) ensure compliance with patient privacy laws relating to:
279 (A) an individual who receives an eligible prescription drug; and
280 (B) patient information that may appear on a donated prescription drug;
281 (ii) clearly identify an eligible prescription drug dispensed under the program; and
282 (iii) communicate necessary information regarding the manufacturer's recommended
283 expiration date or the beyond use date; and
284 (h) ensuring compliance with the requirements of this part;
285 (4) a process for seeking input from:
286 (a) the Department of Health, created in Section 26-1-4, to establish program standards
287 and procedures for assisted living facilities and nursing care facilities; and
288 (b) the Division of Substance Abuse and Mental Health, created in Section
289 62A-15-103, to establish program standards and procedures for mental health and substance
290 abuse clients; and
291 (5) the creation of a special training program that a pharmacist and a licensed pharmacy
292 technician at an eligible pharmacy must complete before participating in the program.