ARIZONA HOUSE OF REPRESENTATIVES

Fifty-fourth Legislature

Second Regular Session

House: HHS DPA 9-0-0-0 | RA DPA 6-0-0-1

HB 2269: donated medicine; requirements

Sponsor:  Representative Barto, LD 15

House Engrossed

Overview

Repeals and rewrites the statute regarding the prescription medicine donation program.

History

As of late 2018, 38 states and Guam had enacted laws for donation of unused prescription drugs, although many of those states do not have functioning medicine donation programs (NCSL).

Arizona enacted law establishing a prescription medicine donation program in 2006 (NCSL). Currently, statute allows a person, manufacturer or health care institution to donate medication to any physician's office, pharmacy or hospital that volunteers to participate in the program and meets requirements established by the Arizona State Board of Pharmacy (Board). Donated medications must have an expiration date of greater than six months after the donation, recipients must be residents of Arizona and meet eligibility standards established by the Board, and health care institutions that participate must inspect donated medicine. Additionally, manufacturers and participants of the program are not subject to liability or professional disciplinary action. Statute also prohibits dispensers of donated medicine from seeking reimbursement for donations and prohibits third party payors from providing reimbursement (A.R.S. § 32-1909).

Provisions

1.    ☐ Prop 105 (45 votes) ☐ Prop 108 (40 votes) ☐ Emergency (40 votes) ☐ Fiscal NoteRepeals the current statute regarding the prescription medicine donation program. (Sec. 1)

2.    Allows an authorized recipient to receive donated medicine after:

a)    Verifying that the donor is authorized to possess the medicine;

b)    Recording the donor's name, address, telephone number and permit or license number; and

c)    Verifying that the donor will remove patient names on donations or otherwise maintain patient confidentiality. (Sec. 2)

3.    Permits an authorized recipient to transfer donations to another authorized recipient. (Sec. 2)

4.    Stipulates that recipients may only accept donated medicine that:

a)    Is in unopened, tamper-evident packaging or that has been appropriately repackaged;

b)    Is not adulterated or misbranded;

c)    Has been maintained in accordance and incompliance with U.S. Food and Drug Administration (FDA) standards; and

d)    Is accompanied by a donor attestation that the donation has been kept in a temperature-controlled environment and is not adulterated. (Sec. 2)

5.    Requires donated medicine that does not meet requirements to be returned to the donor or properly destroyed. (Sec. 2)

6.    Requires a drug manufacturer, repackager, dispenser or wholesaler that participates in the program to comply with federal code on drug supply chain security. (Sec. 2)

7.    Outlines requirements on the reception, storage, inspection and dispensing of donated medicine. (Sec. 2)

8.    Stipulates that when multiple donated medicines with varied expiration dates are repackaged together, the label must express the earliest expiration date. (Sec. 2)

9.    Asserts that dispensed medicine must have an expiration date that is later than the date by which the medicine is expected to be used based on the prescribing directions. (Sec. 2)

10.  Specifies that a recipient may only dispense or administer donated medicine if otherwise allowed by law, pursuant to a valid prescription drug order. (Sec. 2)

11.  Restricts the dispersal of donated medicine to an eligible patient if the prescriber writes or clearly displays on the face of the prescription form "DAW", "dispense as written" or any language that indicates a substitution is not allowed.

12.  Specifies that participation in the program does not require licensing as a wholesale distributor. (Sec. 2)

13.  Prohibits the resale of donated medicine. (Sec. 2)

14.  Allows an authorized recipient to charge a handling, dispensing or administrative fee for donated medicine according to rules prescribed by the Board. (Sec. 2)

15.  Requires an authorized recipient to comply with federal recordkeeping requirements and to retain records for at least seven years. (Sec. 2)

16.  Specifies that a donation's history must begin with the donor of the medicine, include all prior donations and include only drug information required to be on the patient label. (Sec. 2)

17.  Requires a donor or recipient to make all records available for audit by the board within five days of the board's request. (Sec. 2)

18.  Provides immunity, if acting in good faith, to the following:

a)    A person or entity involved in the supply chain of donated medicine; and

b)    A person or entity that prescribes, donates, receives, dispenses, administers, transfers, replenishes or repackages donated medicine. (Sec. 2)

19.  Defines authorized recipient, donor, eligible patient, health care professional, medicine, returns processor and unopened tamper-evident packaging. (Sec. 2)

 

 

 

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Initials IG/ML              House Engrossed

 

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