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This entry was published on 2016-12-02
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Unused prescription drug donation and redispensing program
Public Health (PBH) CHAPTER 45, ARTICLE 2-A, TITLE 2
§ 280-b. Unused prescription drug donation and redispensing program.
1. As used in this section:

(a) "Donor entity" means a manufacturer, wholesaler, or distributor of
prescription drugs; a pharmacy; or a hospital authorized under article
twenty-eight of this chapter.

(b) "Recipient entity" means a manufacturer, wholesaler, or
distributor of prescription drugs; a pharmacy; or a hospital authorized
under article twenty-eight of this chapter.

(c)"Third party intermediary" means a not-for-profit organization that
facilitates the donation or transfer of prescription drugs under this
section but does not take possession or ownership of the prescription

(d) "Redispense" means to dispense a prescription drug that was
donated and received under this section.

2. The commissioner shall make regulations governing the donation and
redispensing of unused prescription drugs under this section.

3. A donor entity may donate unused prescription drugs to a recipient
entity, directly or through a third-party intermediary, in a secure
manner, ensuring the privacy of any individuals for whom the
prescription drugs were initially dispensed or intended to be dispensed.
Prescription drugs redispensed under this section shall be inspected by
a pharmacist or other licensed health care provider as provided by
regulations. The participation of any donor or recipient entity in
redispensing shall be voluntary.

4. Only prescription drugs received by the recipient entity in
tamper-evident packaging as defined by United States pharmacopoeia (USP)
general chapter 659, or in unit-dose or multiple-dose packaging, may be
redispensed. No prescription drugs may be redispensed that:

(a) show evidence of being adulterated or misbranded;

(b) show evidence of packaging having been tampered with;

(c) will expire before the use by the patient based on the prescribing
practitioner's directions for use;

(d) or have been excluded from the program under regulations of the

5. A prescription drug shall not be redispensed if it is restricted to
a patient registered with the drug's manufacturer under federal Food and
Drug Administration requirements including, but not limited to, those
relating to risk evaluation and mitigation strategies (REMS), unless the
redispensing is effectively restricted to ensure that the prescription
drug is only dispensed in accordance with those requirements as

6. A recipient entity may also be a donor entity.

7. Prescription drugs having passed inspection under subdivision three
of this section may be repackaged or prepackaged by the recipient entity
prior to further redispensing.

8. Recipient entities shall give priority for redispensing to patients
who are indigent, uninsured, or under-insured.

9. A redispensed prescription drug shall not be resold by any person
or entity. However, this subdivision does not bar the payment of
reasonable processing fees.

10. No person or entity shall be subject to criminal or civil
liability, or professional discipline for any action taken in reasonable
good faith compliance with this section, except under otherwise
applicable grounds for liability.

11. The department shall work with prospective and approved donor
entities, recipient entities and third-party intermediaries to educate
them about redispensing and promote participation in redispensing. The
department shall maintain a list of recipient entities, and third-party
intermediaries and publish it on the department's website.