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ARIZONA HOUSE OF REPRESENTATIVESFifty-fifth Legislature First Regular Session |
Senate: HHS DP 8-0-0-0 | 3rd Read 29-0-1-0House: HHS DP 9-0-0-0 | 3rd Read 60-0-0-0 |
SB 1219: donated medicine; requirements
Sponsor: Senator Barto, LD 15
Transmitted to the Governor
Overview
Repeals the Prescription Medication Donation Program (Program) and establishes requirements and procedures for the donation, transfer, receipt and facilitation of donated prescription medication.
History
Laws 2006, Chapter 136 required the Board of Pharmacy (Board) to establish the Program to accept and dispense donated prescription medications. A person, manufacturer or health care institution can donate prescription medications to a participating physician's office, pharmacy, hospital or health care institution. A participating entity must dispense donated prescription medicine either directly or through participating governmental or nonprofit private entities. Prescription medications must be accepted or dispensed in their original sealed and tamper-evident unit dose packaging. However, if the medication is packaged in single unit doses, it can be accepted and dispensed even if the outside packaging is opened if the single unit dose packaging is undisturbed (A.R.S. § 32-1909).
Provisions
Donation and Disposal Requirements
1. Permits a donor to donate medicine to an authorized recipient after the authorized recipient verifies and records:
a) That the donor is legally authorized to possess the medicine;
b) The donor's name, address and phone number and permit or license number, if applicable; and
c) That the donor will remove or redact any patient names and prescription numbers on donated medicine or will otherwise maintain patient confidentiality by executing a confidentiality agreement with the authorized recipient. (Sec. 2)
2. Allows an authorized recipient to make a one-time transfer of donated medicine to another authorized recipient or to an entity participating in a drug donation program operated by another state. (Sec. 2)
3. Stipulates an authorized recipient can accept into inventory only donated medicine that:
a) Is in unopened, tamper-evident packaging or that has been repackaged;
b) Is not adulterated or misbranded;
c) Has been maintained in accordance and in compliance the United States Food and Drug Administration risk evaluation and mitigation strategies, if applicable; and
d) Is accompanied by an attestation from the donor stating the medicine being donated has been kept in a temperature-controlled environment and has not been adulterated. (Sec. 2)
4. Permits an authorized recipient to accept into inventory a donated biologic only if the donated biologic meets the aforementioned requirements and is donated by a health care professional or an entity legally authorized to possess the biologic. (Sec. 2)
5. Stipulates that donated medicine that does not meet the aforementioned requirements must be disposed of by returning it to the donor, destroying it in an incinerator, medical waste hauler or other lawful method or transferring it to a returns processor. (Sec. 2)
6. Requires a record of disposed medicine to contain a description of the disposal method, the date of disposal and the name, strength and quantity of each medicine disposed of. (Sec. 2)
7. States a drug manufacturer, repackager, dispenser or wholesaler, other than a returns processor, that participates in this program must comply with federal law relating to drug supply chain security. (Sec. 2)
8. Asserts the donation, transfer, receipt or facilitation of donated medicine is not considered wholesale distribution and does not require licensing as a wholesale distributor. (Sec. 2)
9. States donated medicine cannot be resold and is considered nonsaleable. (Sec. 2)
Inventory, Packaging and Labeling Requirements
10. Asserts all donated medicine received by an authorized recipient but not yet accepted into inventory must be kept in a separate designated area. (Sec. 2)
11. Stipulates that when accepting a donation or transfer into inventory, the authorized recipient must maintain a written or electronic inventory of the donation consisting of the name, strength and quantity of each accepting medicine and the name, address and phone number of the donor. (Sec. 2)
12. Instructs 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 the drug manufacturers' recommendations and United States Pharmacopeia standards. (Sec. 2)
13. Requires repackaged medicine to be labeled with the drug's name, strength and expiration date and kept in a separate designated area until inspected and initialed by a health care professional. (Sec. 2)
14. Requires the earliest expiration date to be used if multiple packaged donated medicines with varied expiration dates are repackaged together. (Sec. 2)
Dispensing Requirements
15. States an authorized recipient can only administer or dispense donated medicine that meets the following requirements:
a) Requirements for accepting donated medicine into inventory based on an inspection by a health care professional;
b) If dispensed to an eligible patient, is repackaged into a new container or has all previous patient information on the donated container redacted or removed;
c) Is properly labeled in accordance with Board rules; and
d) Has an expiration or beyond-use date brought forward from the donated medicine that will not expire before the medicine is completely used by the eligible patient based on the prescribing practitioner's directions for use or, for over-the-counter medicine, on the package's label. (Sec. 2)
16. Permits an authorized recipient to dispense or administer donated medicine to an eligible patient only if otherwise allowed by law. (Sec. 2)
17. Allows donated medicine to be dispensed or administered only to eligible patients pursuant to a valid prescription order and must have patient-specific written or electronic records maintained in accordance with Board rules. (Sec. 2)
18. Prohibits donated medicine from being dispensed or administered to an eligible patient if the prescriber writes or clearly displays, on the face of the description form, DAW, dispense as written or any other language that indicates a substitution is not allowed. (Sec. 2)
Recordkeeping Requirements
19. Stipulates that, when performing an action under this Act or otherwise processing donated medicine for tax, manufacturer or other credit, an authorized recipient is considered to be acting as a returns processor and must comply with all recordkeeping requirements for nonsaleable returns under federal law. (Sec. 2)
20. Requires an authorized recipient to retain all records in a physical or electronic format for at least 7 years. (Sec. 2)
21. Allows a donor and authorized recipient to contract with each other or a third party to create or maintain records on each other's behalf. (Sec. 2)
22. Permits an identifier, such as a serial number or barcode, to be used in place of any information required to be in a record or on a label if the identifier allows for such information to be readily retrievable. (Sec. 2)
23. Requires that, upon request of the Board, the identifier used for requested records be replaced with the original information. (Sec. 2)
24. Asserts a donation or other transfer of possession or control is not a change of ownership unless it is specified as such by the authorized recipient. (Sec. 2)
25. States if a record of the donation's transaction information or history is required, the history must begin with the donor of the medicine and include all prior donations and, if the medicine was previously dispensed, must include only drug information required to be on the patient label in accordance with Board rules. (Sec. 2)
26. Mandates a donor or authorized recipient to make all records available for audit by the Board within five business days after the request. (Sec. 2)
Miscellaneous
27.
Repeals the Program. (Sec. 1)
28. Specifies charging a handling, dispensing or administrative fee is not reselling a donated medicine. (Sec. 2)
29. Mandates the Board prescribe in rule the limits on the fees that an authorized recipient can charge considering the medicine's retail cost for a monthly supply. (Sec. 2)
30. Provides immunity, if acting in good faith, to the following:
a) A person involved in the supply chain of donated medicine, including a donor, authorized recipient, manufacturer, repackager, wholesaler or pharmacy;
b) A person, including any employee, officer, volunteer, owner, partner, member, director, contractor or other person or entity associated with the person, that in compliance prescribes, donates, receives, dispenses, administers, transfers, replenishes or repackages medicine, or facilitates any of these actions. (Sec. 2)
31. Defines authorized recipient, donor, eligible patient, health care professional, medicine, returns processor and unopened, tamper-evident packaging. (Sec. 2)
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