§ 280-B — Unused prescription drug donation and redispensing program

New York § 280-B

• Jurisdiction: New York
• Law PBH: Public Health
• Title 2: Prescription Drugs; Various Provisions
• Art. 2-A: Prescription Drugs

Text

§ 280-b. Unused prescription drug donation and redispensing program.\n1. As used in this section:\n (a) "Donor entity" means a manufacturer, wholesaler, or distributor of\nprescription drugs; a pharmacy; or a hospital authorized under article\ntwenty-eight of this chapter.\n (b) "Recipient entity" means a manufacturer, wholesaler, or\ndistributor of prescription drugs; a pharmacy; or a hospital authorized\nunder article twenty-eight of this chapter.\n (c)"Third party intermediary" means a not-for-profit organization that\nfacilitates the donation or transfer of prescription drugs under this\nsection but does not take possession or ownership of the prescription\ndrugs.\n (d) "Redispense" means to dispense a prescription drug that was\ndonated and received under this section.\n 2. The commissioner shall make regulations governing the donation and\nredispensing of unused prescription drugs under this section.\n 3. A donor entity may donate unused prescription drugs to a recipient\nentity, directly or through a third-party intermediary, in a secure\nmanner, ensuring the privacy of any individuals for whom the\nprescription drugs were initially dispensed or intended to be dispensed.\nPrescription drugs redispensed under this section shall be inspected by\na pharmacist or other licensed health care provider as provided by\nregulations. The participation of any donor or recipient entity in\nredispensing shall be voluntary.\n 4. Only prescription drugs received by the recipient entity in\ntamper-evident packaging as defined by United States pharmacopoeia (USP)\ngeneral chapter 659, or in unit-dose or multiple-dose packaging, may be\nredispensed. No prescription drugs may be redispensed that:\n (a) show evidence of being adulterated or misbranded;\n (b) show evidence of packaging having been tampered with;\n (c) will expire before the use by the patient based on the prescribing\npractitioner's directions for use;\n (d) or have been excluded from the program under regulations of the\ncommissioner.\n 5. A prescription drug shall not be redispensed if it is restricted to\na patient registered with the drug's manufacturer under federal Food and\nDrug Administration requirements including, but not limited to, those\nrelating to risk evaluation and mitigation strategies (REMS), unless the\nredispensing is effectively restricted to ensure that the prescription\ndrug is only dispensed in accordance with those requirements as\napplicable.\n 6. A recipient entity may also be a donor entity.\n 7. Prescription drugs having passed inspection under subdivision three\nof this section may be repackaged or prepackaged by the recipient entity\nprior to further redispensing.\n 8. Recipient entities shall give priority for redispensing to patients\nwho are indigent, uninsured, or under-insured.\n 9. A redispensed prescription drug shall not be resold by any person\nor entity. However, this subdivision does not bar the payment of\nreasonable processing fees.\n 10. No person or entity shall be subject to criminal or civil\nliability, or professional discipline for any action taken in reasonable\ngood faith compliance with this section, except under otherwise\napplicable grounds for liability.\n 11. The department shall work with prospective and approved donor\nentities, recipient entities and third-party intermediaries to educate\nthem about redispensing and promote participation in redispensing. The\ndepartment shall maintain a list of recipient entities, and third-party\nintermediaries and publish it on the department's website.\n