HOUSE BILL 381

48th legislature - STATE OF NEW MEXICO - second session, 2008

INTRODUCED BY

Andrew J. Barreras

AN ACT

RELATING TO DRUGS AND COSMETICS; PROVIDING FOR THE DONATION OF CANCER DRUGS AND MEDICAL DEVICES; 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] CANCER DRUGS AND MEDICAL DEVICES DONATION.--

          A. As used in this section:

                (1) "cancer drug" means a prescription drug that is used to treat cancer or the side effects of cancer;

                (2) "department" means department of health;

                (3) "dispense" means to deliver a cancer drug to an eligible patient pursuant to the lawful order of a practitioner, including the administering, prescribing, packaging, labeling or compounding necessary to prepare the cancer drug for that delivery;

                (4) "eligible patient" means an uninsured or underinsured cancer patient who meets the eligibility criteria established by rule by the board;

                (5) "health care facility" means an institution providing health care services, including a hospital, clinic or other inpatient center, outpatient facility or diagnostic or treatment center, that is licensed by the department;

                (6) "pharmaceutical care" means the provision of drug therapy and other patient-care services related to drug therapy intended to achieve definite outcomes that improve a patient's quality of life, including identifying potential and actual drug-related problems, resolving actual drug-related problems and preventing potential drug-related problems;

                (7) "pharmacist" means a person licensed as a pharmacist pursuant to the Pharmacy Act;

                (8) "pharmacy" means a licensed place of business where drugs are compounded or dispensed and pharmaceutical care is provided; and

                (9) "program" means the cancer drug and medical device repository program created in this section.

          B. There is hereby created the "cancer drug and medical-device repository program" for the purpose of allowing a cancer patient or the patient's family to donate unused cancer drugs and medical devices to uninsured and underinsured cancer patients in New Mexico. The program shall be administered by the department. The program shall allow a cancer patient or the patient's family to donate unused cancer drugs or medical devices to a health care facility or pharmacy that elects to participate in the program. A health care facility or pharmacy that receives a donated cancer drug or medical device under the program may distribute the cancer drug or medical device to another eligible health care facility or pharmacy for use pursuant to the program.

          C. A pharmacist may accept and dispense cancer drugs and medical devices donated pursuant to the program to eligible patients if all of the following requirements are met:

                (1) the cancer drug or medical device is in its original, unopened, sealed and tamper-evident packaging or, if packaged in single-unit doses, the single-unit-dose packaging is unopened;

                (2) the pharmacist has determined that the cancer drug or medical device is safe for redistribution;

                (3) the cancer drug bears an expiration date that has not expired;

                (4) the cancer drug or medical device is not adulterated or misbranded, as determined by a pharmacist; and

                (5) the cancer drug or medical device is prescribed by a practitioner for use by an eligible patient and is dispensed by a pharmacist.

          D. A cancer drug or medical device donated pursuant to the program shall not be resold. A health care facility or pharmacy may charge an eligible patient a handling fee to receive a donated cancer drug or medical device, which fee shall not exceed the amount specified in rule adopted by the board.

          E. Nothing in this section requires a health care facility or pharmacy to participate in the program.

          F. A health care facility or pharmacy that elects to participate in the program shall establish eligibility criteria for individuals to receive donated cancer drugs or medical devices. Dispensation shall be prioritized to cancer patients who are uninsured or underinsured. Dispensation to other cancer patients shall be permitted if an uninsured or underinsured cancer patient is not available.

          G. The department, in consultation with the board, shall adopt rules necessary for the implementation and administration of the program. The rules shall include:

                (1) requirements for health care facilities and pharmacies to accept and dispense donated cancer drugs and medical devices pursuant to the program, including:

                     (a) eligibility criteria; and

                     (b) standards and procedures for a health care facility or pharmacy to accept, safely store and dispense donated cancer drugs and medical devices; and

                (2) the amount of the maximum handling fee that a health care facility or pharmacy may charge for distributing or dispensing donated cancer drugs or medical devices.

          H. Nothing in this section shall be construed to create or abrogate any liability on behalf of a prescription drug manufacturer for the storage, donation, acceptance or dispensing of a cancer drug or medical device, or to create any civil cause of action against a prescription drug manufacturer in addition to any liabilities that are available under applicable law."

- 5 -