24:6M-3 Establishment, maintenance of drug donation program.

3. a. No later than six months after the enactment of this act, the commissioner, in cooperation with the board, shall authorize one or more private entities to establish and maintain a drug donation program, pursuant to which a donor may donate over-the-counter drugs, prescription drugs, and administration supplies to a redistributor for final dispensing to an individual who meets the eligibility criteria established by the entity for the purposes of its program.

b. An entity that establishes a drug donation program pursuant to this act may contract with a third-party intermediary to implement and administer the program.

c. An entity that establishes a drug donation program pursuant to this act shall develop, implement, and make available, upon request of the commissioner, the board, or the public:

(1) standards and procedures for accepting, safely storing, and dispensing donated drugs and administration supplies;

(2) standards and procedures for inspecting donated drugs to ensure that the drugs are contained in sealed, tamper-evident packaging, including, but not limited to, intact single-unit doses or blister packs;

(3) standards and procedures for inspecting donated drugs to ensure that the drugs are not adulterated or misbranded;

(4) eligibility criteria for individuals to receive donated drugs and administration supplies dispensed under the program, which criteria shall prioritize the dispensing of donated drugs and administration supplies to individuals who are indigent, uninsured, or enrolled in a public health benefits program, but may permit dispensing to other individuals if a need for the donated drugs and administration supplies is not identified among persons who are indigent, uninsured, or enrolled in a public health benefits program;

(5) a means by which an individual may indicate that the individual is eligible to receive donated drugs and administration supplies under the program, which may comprise in part or whole of self-certification;

(6) a list of over-the-counter drugs and prescription drugs that the program is seeking, will accept, and will not accept, including a list of those drugs that an individual redistributor participating in the program is seeking, will accept, and will not accept;

d. Donated over-the-counter drugs, prescription drugs, and administration supplies may be transferred from one redistributor to another redistributor in this State, and may be transferred to or from a redistributor in another state, provided that such transfer is permitted under the laws of that other state. The donation, transfer, or facilitation of donations and transfers of over-the-counter drugs or prescription drugs pursuant to this subsection shall not be deemed to constitute wholesale distribution and shall not require licensing as a wholesaler.

e. (1) Any over-the-counter drugs, prescription drugs, and administration supplies that a donor legally possesses, including, but not limited to, over-the-counter drugs, prescription drugs, and administration supplies that are discontinued in a health care facility, and that would otherwise be destroyed, are eligible for donation under this act.

(2) A prescription drug that can only be dispensed to a patient who is registered with the manufacturer of that drug, in accordance with requirements established by the federal Food and Drug Administration, shall not be accepted or distributed by any drug donation program.

f. A common carrier or contract carrier may be used to transport donated over-the-counter drugs, prescription drugs, and administration supplies, in accordance with manufacturer recommendations, including but not limited to, from a donor to a redistributor, from a redistributor to another redistributor, from a redistributor to a donor, or from a redistributor to an eligible patient.

g. The participation of any person, facility, or other entity in a drug donation program established under this act shall be voluntary.

L.2017, c.254, s.3.