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8 LONG TITLE
9 General Description:
10 This bill modifies the Charitable Prescription Drug Recycling Act.
11 Highlighted Provisions:
12 This bill:
13 ▸ allows an individual to transfer prescription drugs to an eligible pharmacy or an
14 eligible physician's office;
15 ▸ removes the requirement that only state residents receive donated drugs; and
16 ▸ requires that a medically indigent individual be located in the state when the drug is
17 dispensed.
18 Money Appropriated in this Bill:
19 None
20 Other Special Clauses:
21 None
22 Utah Code Sections Affected:
23 AMENDS:
24 58-17b-902, as last amended by Laws of Utah 2020, Chapter 384
25 58-17b-903, as last amended by Laws of Utah 2020, Chapter 384
26 58-17b-905, as enacted by Laws of Utah 2016, Chapter 405
27 58-17b-907, as last amended by Laws of Utah 2020, Chapter 384
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29 Be it enacted by the Legislature of the state of Utah:
30 Section 1. Section 58-17b-902 is amended to read:
31 58-17b-902. Definitions.
32 As used in this part:
33 (1) "Assisted living facility" means the same as that term is defined in Section 26-21-2.
34 (2) "Cancer drug" means a drug that controls or kills neoplastic cells and includes a
35 drug used in chemotherapy to destroy cancer cells.
36 (3) "Charitable clinic" means a charitable nonprofit corporation that:
37 (a) holds a valid exemption from federal income taxation issued under Section 501(a),
38 Internal Revenue Code;
39 (b) is exempt from federal income taxation under Section 501(c)(3), Internal Revenue
40 Code;
41 (c) provides, on an outpatient basis, for a period of less than 24 consecutive hours, to
42 an individual not residing or confined at a facility owned or operated by the charitable
43 nonprofit corporation:
44 (i) advice;
45 (ii) counseling;
46 (iii) diagnosis;
47 (iv) treatment;
48 (v) surgery; or
49 (vi) care or services relating to the preservation or maintenance of health; and
50 (d) has a licensed outpatient pharmacy.
51 (4) "Charitable pharmacy" means an eligible pharmacy that is operated by a charitable
52 clinic.
53 (5) "County health department" means the same as that term is defined in Section
54 26A-1-102.
55 (6) "Donated prescription drug" means a prescription drug that an eligible donor or
56 individual donates to an eligible pharmacy under the program.
57 (7) "Eligible donor" means a donor that donates a prescription drug from within the
58 state and is:
59 (a) a nursing care facility;
60 (b) an assisted living facility;
61 (c) a licensed intermediate care facility for people with an intellectual disability;
62 (d) a manufacturer;
63 (e) a pharmaceutical wholesale distributor;
64 (f) an eligible pharmacy; or
65 (g) a physician's office.
66 (8) "Eligible pharmacy" means a pharmacy that:
67 (a) is registered by the division as eligible to participate in the program; and
68 (b) (i) is licensed in the state as a Class A retail pharmacy; or
69 (ii) is operated by:
70 (A) a county;
71 (B) a county health department;
72 (C) a pharmacy under contract with a county health department;
73 (D) the Department of Health, created in Section 26-1-4;
74 (E) the Division of Substance Abuse and Mental Health, created in Section
75 62A-15-103; or
76 (F) a charitable clinic.
77 (9) "Eligible prescription drug" means a prescription drug, described in Section
78 58-17b-904, that is not:
79 (a) a controlled substance; or
80 (b) a drug that can only be dispensed to a patient registered with the drug's
81 manufacturer in accordance with federal Food and Drug Administration requirements.
82 (10) "Licensed intermediate care facility for people with an intellectual disability"
83 means the same as that term is defined in Section 58-17b-503.
84 (11) "Medically indigent individual" means an individual who:
85 (a) (i) does not have health insurance; and
86 (ii) lacks reasonable means to purchase prescribed medications; or
87 (b) (i) has health insurance; and
88 (ii) lacks reasonable means to pay the insured's portion of the cost of the prescribed
89 medications.
90 (12) "Nursing care facility" means the same as that term is defined in Section
91 26-18-501.
92 (13) "Physician's office" means a fixed medical facility that:
93 (a) is staffed by a physician, physician's assistant, nurse practitioner, or registered
94 nurse, licensed under Title 58, Occupations and Professions; and
95 (b) treats an individual who presents at, or is transported to, the facility.
96 (14) "Program" means the Charitable Prescription Drug Recycling Program created in
97 Section 58-17b-903.
98 (15) "Unit pack" means the same as that term is defined in Section 58-17b-503.
99 (16) "Unlawful conduct" means the same as that term is defined in Sections 58-1-501
100 and 58-17b-501.
101 (17) "Unprofessional conduct" means the same as that term is defined in Sections
102 58-1-501 and 58-17b-502.
103 Section 2. Section 58-17b-903 is amended to read:
104 58-17b-903. Charitable Prescription Drug Recycling Program -- Creation --
105 Requirements.
106 (1) There is created the Charitable Prescription Drug Recycling Program.
107 (2) The division, in consultation with the board, shall:
108 (a) implement the program, on a statewide basis, to permit:
109 (i) an individual or an eligible donor to transfer an eligible prescription drug to an
110 eligible pharmacy for dispensing to a medically indigent individual; and
111 (ii) an individual to transfer an eligible prescription drug to a physician's office:
112 (A) that is an eligible donor; and
113 (B) for transfer to an eligible pharmacy for dispensing to a medically indigent
114 individual;
115 (b) in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act,
116 make rules necessary to implement the program; and
117 (c) provide technical assistance to entities that desire to participate in the program.
118 Section 3. Section 58-17b-905 is amended to read:
119 58-17b-905. Participation in program -- Requirements -- Fees.
120 (1) An eligible donor, an individual, or an eligible pharmacy may participate in the
121 program.
122 (2) An eligible pharmacy:
123 (a) shall comply with all applicable federal and state laws related to the storage and
124 distribution of a prescription drug;
125 (b) shall comply with all applicable federal and state laws related to the acceptance and
126 transfer of a prescription drug, including 21 U.S.C. Chapter 9, Subchapter V, Part H,
127 Pharmaceutical Distribution Supply Chain;
128 (c) shall, before accepting or dispensing a prescription drug under the program, inspect
129 each prescription drug to determine whether the prescription drug is an eligible prescription
130 drug;
131 (d) may dispense an eligible prescription drug to a medically indigent individual who:
132 (i) [
133 (ii) has a prescription issued by a practitioner;
134 (e) may charge a handling fee, adopted by the division under Section 63J-1-504; and
135 (f) may not accept, transfer, or dispense a prescription drug in violation of the federal
136 Food, Drug, and Cosmetic Act, 21 U.S.C. Sec. 301 et seq.
137 Section 4. Section 58-17b-907 is amended to read:
138 58-17b-907. Rules made by the division.
139 The rules made by the division under Subsection 58-17b-903(2)(b) shall include:
140 (1) registration requirements to establish the eligibility of a pharmacy to participate in
141 the program;
142 (2) a formulary that includes all eligible prescription drugs approved by the federal
143 Food and Drug Administration;
144 (3) standards and procedures for:
145 (a) verifying whether a pharmacy or pharmacist participating in the program is licensed
146 and in good standing with the board;
147 (b) handling of an eligible prescription drug transferred in accordance with Subsection
148 58-17b-903(2) to an eligible pharmacy or a physician's office, including:
149 (i) acceptance;
150 (ii) identification, including redundant criteria for verification;
151 (iii) documentation, under 21 U.S.C. Sec. 360eee-1, of transaction information, history,
152 and statements;
153 (iv) safe storage;
154 (v) security;
155 (vi) inspection;
156 (vii) transfer; and
157 (viii) dispensing;
158 (c) a pharmacist, pharmacy intern, or licensed pharmacy technician:
159 (i) working in or consulting with a participating eligible donor; or
160 (ii) assisting an individual donating the eligible prescription drug;
161 (d) disposition of a donated prescription drug that is a controlled substance;
162 (e) record keeping regarding:
163 [
164 [
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166 (i) the individual or eligible donor that transferred an eligible prescription drug under
167 Subsection 58-17b-903(2)(a);
168 [
169 pharmacist or licensed pharmacy technician; and
170 [
171 (f) determining the status of a medically indigent individual;
172 (g) labeling requirements to:
173 (i) ensure compliance with patient privacy laws relating to:
174 (A) an individual who receives an eligible prescription drug; and
175 (B) patient information that may appear on a donated prescription drug;
176 (ii) clearly identify an eligible prescription drug dispensed under the program; and
177 (iii) communicate necessary information regarding the manufacturer's recommended
178 expiration date or the beyond use date; and
179 (h) ensuring compliance with the requirements of this part;
180 (4) a process for seeking input from:
181 (a) the Department of Health, created in Section 26-1-4, to establish program standards
182 and procedures for assisted living facilities and nursing care facilities; and
183 (b) the Division of Substance Abuse and Mental Health, created in Section
184 62A-15-103, to establish program standards and procedures for mental health and substance
185 abuse clients; and
186 (5) the creation of a special training program that a pharmacist and a licensed pharmacy
187 technician at an eligible pharmacy must complete before participating in the program.