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ARIZONA STATE SENATE
Fifty-Fifth Legislature, First Regular Session
donated medicine; requirements
Purpose
Establishes requirements and prohibitions for donating, accepting and dispensing donated prescription medications.
Background
Current statute directs the Arizona State Board of Pharmacy (Board) to establish a Prescription Medication Donation Program (Program) to accept and dispense prescription medications. Donations can be made at physicians' offices, pharmacies and specified health care institutions (HCIs) that opt-in to the Program and meet prescribed criteria. Donations to the Program can be accepted from individuals, manufacturers and HCIs. Statute requires that prescription medications be accepted or dispensed by the Program only in the original, sealed and tamper-evident unit dose packaging, except that opened prescription medications packaged in single unit doses can be accepted and dispensed if the single unit dose packaging is undisturbed. Prescription donations cannot be accepted if the medication expires within six months or if the medication is deemed to be adulterated.
Prescription medication donated to the Program can only be dispensed pursuant to a prescription order or directly through a participating governmental or nonprofit private entity. Additionally, medication donated to the Program can only be dispensed to eligible Arizona residents. Physicians' offices, pharmacies and HCIs that participate in the Program are authorized to charge a Board-prescribed handling fee to cover the costs of inspection, stocking and dispensing a donated prescription medication (A.R.S. § 32-1909).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Permits the donation and receipt of medicine to authorized recipients.
2. Directs an authorized recipient, prior to a donor making its first donation, to verify and record:
a) that the donor is legally authorized to possess the medicine;
b) the donor's name, address, telephone number and applicable permit or license number; and
c) that the donor will remove or redact any patient names and prescription numbers on donated prescription medicine (donated medicine) or maintain patient confidentiality by executing a confidentiality agreement with the authorized recipient.
3. Allows an authorized recipient to transfer donated medicine to another authorized recipient or to an entity participating in a drug donation program in another state and limits such transfers to one per donated medicine.
4. Requires authorized recipients to only accept donated medicine that:
a) is in unopened, tamper-evident packaging or has been repackaged as prescribed;
b) is not adulterated or misbranded;
c) has been maintained in compliance with the Food and Drug Administration risk evaluation and mitigation strategies, if applicable; and
d) is accompanied by an attestation from the donor stating that the donated medicine is unadulterated and has been kept in a temperature-controlled environment.
5. Allows an authorized recipient to accept a donated biologic that meets the prescribed requirements of donated medicine and that is donated by a health care professional or an entity legally authorized to possess the biologic.
6. Requires donated medicine that does not meet the prescribed requirements be disposed of by:
a) returning to the donor;
b) incineration;
c) destruction by a medical waste hauler or other lawful method; or
d) transferring to a returns processor.
7. Establishes that a record of the disposed medicine must contain a description of the disposal method, disposal date, and name, strength and quantity of disposed medicine.
8. Directs drug manufacturers, repackagers, dispensers and wholesalers that participate in the Program to comply with federal law relating to drug supply chain security.
9. Requires an authorized recipient to keep donated medicine that has been received, but not yet accepted into inventory, in a separate designated area.
10. Requires an authorized recipient to store and maintain donated medicine physically or electronically separated from other inventory and in a secure and temperature-controlled environment that meets applicable standards.
11. Directs the authorized recipient to maintain a written or electronic inventory of donations consisting of the name, strength and quantity of each accepted medicine and the name, address and phone number of the donor, with certain exemptions.
12. Requires repackaged donated medicine to be labeled with the drug's name, strength and expiration date and kept in a designated area until inspected.
13. Specifies that, for multiple repackaged donated medicines with varied expiration dates, the earliest expiration date is used.
14. Allows an authorized recipient to administer or dispense donated medicine that:
a) meets prescribed requirements for acceptance into inventory;
b) is repackaged into a container that has all previous patient information removed;
c) is properly labeled in accordance with Board rules; and
d) has an expiration date brought forward from the donated medicine that will not expire before complete use of the medication by the patient based on the prescriber's directions for use or the package's label.
15. States that an authorized recipient can only dispense or administer donated medicine to eligible patients as allowed by law and pursuant to a prescription drug order.
16. Requires dispensed donated medicine to have patient-specific records maintained in accordance with Board rules.
17. Prohibits dispensing or administering donated medicine if the prescriber indicates that a substitution is not allowed on the prescription form.
18. Specifies that the donation, transfer, receipt or facilitation of donated medicine is not considered wholesale distribution and does not require licensure.
19. Prohibits donated medicine from being resold and renders donated medicine nonsaleable.
20. Specifies that charging a permitted handling, dispensing or administrative fee does not constitute the resale of donated medicine.
21. Directs the Board to prescribe, in rule, limitations on fees that an authorized recipient is permitted to charge in consideration of the donated medication's monthly supply retail cost.
22. Considers an authorized recipient to be acting as a returns processor when performing actions related to the Program and requires compliance with bookkeeping requirements for nonsaleable returns as prescribed by federal law.
23. Requires an authorized recipient to retain required records for at least seven years and allows a donor and authorized recipient to contract with each other, or a third party, to create or maintain records.
24. Allows the use of an identifier in place of required information to be included in a record or label, if the identifier allows such information to be readily retrievable.
25. Requires identifiers to be replaced with original information, upon Board request, and prohibits use of identifiers on patient labels of dispensed donated medicine.
26. Stipulates that a donation or transfer of possession or control is not a change of ownership, unless indicated by the authorized recipient.
27. Requires that records of a donation transaction history begin with the medicine donor, including prior donations and drug information on the patient label, as required by Board rule.
28. Obligates donors and authorized recipients to make all records available for audit by the Board within five days of request.
29. Exempts a person or entity, acting in good faith, from civil or criminal liability or professional disciplinary action, who is:
a) involved in the supply chain of donated medicine, including a donor, authorized recipient, manufacturer, repackager, wholesaler or pharmacy; or
b) associated with another person or entity that prescribes, donates, receives, dispenses, administers, transfers, replenishes or repackages donated medicine as prescribed.
30. Specifies that otherwise legal activities related to nonprescription drugs are not prohibited.
31. Repeals current statute directing the Board to establish the Program.
32. Defines relevant terms.
33. Becomes effective on the general effective date.
Prepared by Senate Research
January 25, 2021
CRS/JP/kja