1     
CHARITABLE PRESCRIPTION DRUG RECYCLING

2     
PROGRAM

3     
2016 GENERAL SESSION

4     
STATE OF UTAH

5     
Chief Sponsor: Gage Froerer

6     
Senate Sponsor: Evan J. Vickers

7     

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
41     

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 [of] any unused drug, or a part of it, after it
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" [has the same definition as] means the same as that term is
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) [Notwithstanding the provisions of Subsection 58-17b-502(5), a] A pharmacist
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          [(a)] (i) the drug was prescribed to a patient in a nursing care facility, [a] licensed
108     intermediate care facility for people with an intellectual disability, or state prison facility,
109     county jail, or state hospital;
110          [(b)] (ii) the drug was stored under the supervision of a licensed health care provider
111     according to manufacturer recommendations;
112          [(c)] (iii) the drug is in a unit pack or in the manufacturer's sealed container;
113          [(d)] (iv) the drug was returned to the original dispensing pharmacy;

114          [(e)] (v) the drug was initially dispensed by a licensed pharmacist or licensed pharmacy
115     intern; and
116          [(f)] (vi) accepting back and [redistribution] redistributing of the drug complies with
117     federal Food and Drug Administration and Drug Enforcement Administration regulations.
118          Section 3. Section 58-17b-901 is enacted to read:
119     
Part 9. Charitable Prescription Drug Recycling Act

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.