N.Y. Public Health Law § 280-b: Unused prescription drug donation and redispensing program

§ 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

drugs.

(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

commissioner.

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

applicable.

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.