HOUSE BILL 46

48th legislature - STATE OF NEW MEXICO - first session, 2007

INTRODUCED BY

John A. Heaton

AN ACT

RELATING TO DRUGS AND COSMETICS; PROVIDING FOR PRESCRIPTION MEDICATION DONATION; ENACTING A NEW SECTION OF THE NEW MEXICO DRUG, DEVICE AND COSMETIC ACT.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF NEW MEXICO:

     Section 1. A new section of the New Mexico Drug, Device and Cosmetic Act is enacted to read:

     "[NEW MATERIAL] PRESCRIPTION MEDICATION DONATION.--

          A. As used in this section:

                (1) "pharmacy" means a retail pharmacy, hospital pharmacy, community health clinic or public health office; and

                (2) "tamper-evident" means a device or process that makes unauthorized access to protected pharmaceutical packaging easily detected.

          B. A person may donate prescription medication to a pharmacy's prescription medication donation program, and a pharmacy may accept and dispense the donated prescription medication in accordance with rules promulgated by the board.

          C. The board shall promulgate rules to include:

                (1) eligibility criteria for pharmacies to receive and dispense donated prescription medication;

                (2) standards and procedures for accepting, storing and dispensing donated prescription medication;

                (3) standards and procedures for inspecting donated prescription medication to determine that the packaging is tamper-evident and that the donated prescription medication is unadulterated, safe and suitable for dispensing;

                (4) eligibility standards, based on economic need, for a person receiving donated prescription medication;

                (5) any other standards deemed necessary by the board;

                (6) the means, such as an identification card, by which a person may show eligibility to receive donated prescription medication;

                (7) a form to be signed by the eligible person before receipt of the donated prescription medication to confirm that the recipient understands the immunity provisions of the program;

                (8) a handling fee not to exceed twenty dollars ($20.00), that may be charged to the eligible person by the participating pharmacy to cover the costs of inspection, stocking and dispensing the prescription medication;

                (9) a list of prescription medications that a participating pharmacy shall not accept; and

                (10) a form to be signed by the person donating prescription medication verifying that:

                     (a) the person is the owner of the prescription medication;

                     (b) the prescription medication has been properly stored and the container has not been opened or tampered with;

                     (c) the prescription medication is not adulterated or misbranded; and

                     (d) the person is voluntarily donating the prescription medication.

          D. The board shall maintain and publish a current listing of participating pharmacies.

          E. Only prescription medication in its original tamper-evident or licensed facility-prepared tamper-evident packaging shall be accepted or dispensed under the prescription medication donation program. Prescription medication packaged in single unit doses with the outside packaging opened may be accepted and dispensed as long as the single unit dose packaging is undisturbed.

          F. Prescription medication dated to expire within six months after donation or deemed adulterated or misbranded shall not be accepted.

          G. A participating pharmacy shall only dispense donated prescription medication pursuant to a prescription order to a person who is a resident of this state and meets the eligibility standards promulgated by the board.

          H. Before dispensing donated prescription medication, the participating pharmacy shall:

                (1) comply with all applicable federal laws and the laws of the state that deal with the storage, distribution and labeling of dangerous drugs; and

                (2) examine the donated prescription medication to determine that it has not been adulterated or misbranded and certify that the prescription medication has been stored in compliance with the requirements of the product label.

          I. Notwithstanding any other provision of law, a person who donates prescription medication in good faith to a participating pharmacy shall not be subject to any criminal penalty or be liable for any civil damages arising from the condition of the prescription medication unless an injury arising from the prescription medication is caused by the gross negligence, recklessness or intentional conduct of the person who donates the prescription medication.

          J. Notwithstanding any other provision of law, a participating pharmacy that in good faith receives a prescription medication and distributes it at no charge, other than a handling fee, shall not be subject to any criminal penalty or be liable for any civil damages resulting from the condition of the prescription medication unless an injury arising from the prescription medication is caused by the gross negligence, recklessness or intentional conduct of the participating pharmacy.

          K. This section does not restrict the authority of an appropriate governmental agency to regulate or ban the use of any prescription medication.

          L. Notwithstanding any other provision of law, a participating pharmacy shall not submit a claim or otherwise seek reimbursement from a public or private third-party payor for the donation of the prescription medication, and a public or private third-party payor shall not provide reimbursement for donation of a prescription medication pursuant to this section."

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