SENATE BILL 37

50th legislature - STATE OF NEW MEXICO - first session, 2011

INTRODUCED BY

Dede Feldman

AN ACT

RELATING TO PRESCRIPTION DRUGS; PROVIDING FOR PRESCRIPTION DRUG 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 DRUG DONATION.--

          A. As used in this section:

                (1) "clinic" means a facility licensed pursuant to Section 61-11-14 NMSA 1978 in which one or more licensed practitioners diagnose and treat patients and in which drugs are stored, dispensed or administered for the diagnosis and treatment of the facility's patients; provided that "clinic" does not include the privately owned practice of a licensed practitioner or group of licensed practitioners exempt under Section 61-11-22 NMSA 1978;

                (2) "donor" means an individual who donates unused prescription drugs to a clinic or a participating practitioner for the purpose of redistribution to established patients of that clinic or practitioner;

                (3) "participating practitioner" means a licensed practitioner who is authorized to prescribe drugs and who registers with the board, and is subject to rules promulgated by the board, to participate in the collection of donated drugs, prescribed for use by established patients of that practitioner and donated for the purpose of redistribution to established patients of that practitioner;

                (4) "recipient" means an individual who voluntarily receives donated prescription drugs; and

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

          B. Unused prescription drugs may be donated to a clinic or a participating practitioner and a clinic or a participating practitioner may accept and redistribute the donated prescription drugs in accordance with rules promulgated by the board.

          C. The board shall establish procedures to allow the donation and redistribution of certain prescription drugs, including refrigerated drugs, that: 

                (1) ensure that the redistribution process is consistent with public health and safety standards; and

                (2) exclude controlled substances and drugs required by the United States food and drug administration to have a risk evaluation and mitigation strategy.

          D. The board shall promulgate rules to include:

                (1) standards and procedures for accepting, storing, labeling and redistributing donated prescription drugs;

                (2) standards and procedures for inspecting donated prescription drugs to determine that the packaging is tamper-evident and that the donated prescription drugs are unadulterated, safe and suitable for redistribution;

                (3) a form to be signed by the recipient specifying:

                     (a) knowledge that the donor is not a pharmacist and took ordinary care of the donated prescription drug;

                     (b) knowledge that the donor is known to the clinic or the participating practitioner and that there is no reason to believe that the donated prescription drug was improperly handled or stored;

                     (c) that by accepting the donated prescription drug, the recipient accepts any risks that an accidental mishandling could create;

                     (d) the release of the donor and the clinic or participating practitioner from liability; and

                     (e) the release of the pharmaceutical manufacturer for any claim or injury arising from the transfer of any prescription drug of that manufacturer pursuant to this section;

                (4) a form to be signed by the donor verifying that:

                     (a) the donor is the owner of the donated prescription drug;

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

                     (c) the donated prescription drug has not been adulterated or misbranded; and

                     (d) the donor is voluntarily donating the prescription drug;

                (5) a handling fee not to exceed twenty dollars ($20.00) that may be charged to the recipient by the clinic or the participating practitioner to cover the costs of inspecting, storing, labeling and redistributing the donated prescription drug; and

                (6) any other standards deemed necessary by the board.

          E. The board shall maintain and publish a current listing of clinics and participating practitioners.

          F. Before redistributing donated prescription drugs, the clinic or the participating practitioner shall:

                (1) comply with all applicable federal laws and the laws of the state that deal with the inspection, storage, labeling and redistribution of donated prescription drugs; and

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

          G. A donor acting in good faith shall not be subject to any penalty pursuant to Section 26-1-26 NMSA 1978.

          H. A clinic or participating practitioner that, in good faith, receives a donated prescription drug and redistributes it at no charge, other than a handling fee, shall not be subject to any penalty pursuant to Section 26-1-26 NMSA 1978 resulting from the condition of the donated drug unless an injury arising from the donated drug is caused by the gross negligence, recklessness or intentional conduct of the clinic or participating practitioner.

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