Bill H.2155

HOUSE DOCKET, NO. 2139 FILED ON: 1/14/2009

HOUSE . . . . . . . . . . . . . . . No. 2155

The Commonwealth of Massachusetts

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In the Year Two Thousand Nine

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An Act providing for the establishment and operation of a drug repository program..

Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:

SECTION 1. Notwithstanding any general or special law to the contrary, the Department of Public Health and the Board of Registration in Pharmacy shall establish a drug repository program to accept and dispense prescription drugs donated for the purpose of being dispensed to individuals who are residents of the Commonwealth and meet the eligibility standards established in the administrative regulations promulgated by the Department and the Board pursuant to Section 5 of this Act.

SECTION 2. Only drugs in their original sealed and tamper-evident unit dose packaging may be accepted and dispensed. The packaging must be unopened, except that drugs packaged in single unit doses may be accepted and dispensed when the outside packaging is opened if the single unit dose packaging is undisturbed. Drugs donated by individuals bearing an expiration date that is less than six months from the date the drug is donated shall not be accepted or dispensed. A drug shall not be accepted or dispensed if there is reason to believe that it is adulterated pursuant to section 186 of chapter 94 of the General Laws, as appearing in the 2004 Official Edition. Nothing in this section shall be construed as prohibiting a pharmacy from accepting drugs that are not eligible to be dispensed under the drug repository program for the proper disposal of those drugs.

SECTION 3. (a) Any person, including a drug manufacturer, health care facility, or government entity, may donate prescription drugs to the drug repository program. The drugs must be donated at a pharmacy, hospital, or a nonprofit clinic that elects to participate in the drug repository program and meets the criteria for participation established by rule of the Department. Participation in the program by pharmacies, hospitals and nonprofit clinics shall be voluntary. Nothing in this Act shall require a pharmacy, hospital or nonprofit clinic to participate in the program.

(b) A pharmacy, hospital, or nonprofit clinic that participates in the program shall dispense drugs to individuals who meet the eligibility standards established, or to other government entities and nonprofit private entities to be dispensed to individuals who meet the eligibility standards. A drug may be dispensed only pursuant to a valid drug order. A pharmacy, hospital or nonprofit clinic that accepts donated drugs shall comply with all applicable federal laws and laws of the Commonwealth dealing with storage and distribution of dangerous drugs and shall inspect all drugs before dispensing them to determine that they are not adulterated. The pharmacy, hospital, or nonprofit clinic may charge individuals receiving donated drugs a handling fee established in accordance with the administrative regulations promulgated by the Department and the Board under Section 5 of this Act.

SECTION 4. (a) The Department of Public Health; the Board of Registration in Pharmacy, any person, including a drug manufacturer, health care facility, or government entity that donates drugs to the repository program; any pharmacy, hospital, nonprofit clinic or health care professional that accepts or dispenses drugs under the program; and any pharmacy, hospital, or nonprofit clinic that employs a health care professional who accepts or dispenses drugs under the program shall not, in the absence of bad faith, be subject to any criminal prosecution, liability in tort or other civil action for injury, death, or loss to person or property; or professional disciplinary action, relating to donating, accepting, or dispensing drugs under the drug repository program.

(b) A drug manufacturer shall not, in the absence of bad faith, be subject to criminal prosecution or liability in tort or other civil action for injury, death, or loss to person or property for matters related to the donation, acceptance, or dispensing of a drug manufactured by the drug manufacturer that is donated under the program, including but not limited to liability for failure to transfer or communicate product or consumer information or the expiration date of the donated drug.

SECTION 5. In consultation with the Department of Public Health, the Board of Registration in Pharmacy shall establish rules and regulations governing the drug repository program that establish all of the following:

(a) Eligibility criteria for pharmacies, hospitals, and nonprofit clinics to receive and dispense donated drugs under the program;

(b) Standards and procedures for accepting, safely storing, and dispensing donated drugs;

(c) Standards and procedures for inspecting donated drugs to determine that the original unit dose packaging is sealed and tamper-evident and that the drugs are unadulterated, safe and suitable for dispensing;

(d) Eligibility standards based on economic need for individuals to receive drugs;

(e) A means, such as an identification card, by which an individual who is eligible to receive donated drugs may demonstrate eligibility to the pharmacy, hospital, or nonprofit clinic dispensing the drugs;

(f) A form that an individual receiving a drug from the repository must sign before receiving the drug to confirm that the individual understands the immunity provisions of the program;

(g) A formula to determine the handling fee that pharmacies, hospitals, and nonprofit clinics may charge to drug recipients to cover restocking and dispensing costs;

(h) For drugs donated to the repository by individuals:

1. A list of drugs, arranged either by category or by individual drug, that the repository will accept from individuals;

2. A list of drugs, arranged either by category or by individual drug, that the repository will not accept from individuals, including a statement as to why the drug is ineligible for donation; and

3. A form each donor must sign stating that the donor is the owner of the drugs and intends to voluntarily donate them to the repository;

(i) For drugs donated to the repository by health care facilities or governmental entities:

1. A list of drugs, arranged either by category or by individual drug, that the repository will accept from health care facilities or governmental entities;

2. A list of drugs, arranged either by category or by individual drug, that the repository will not accept from health care facilities or governmental entities, including a statement as to why the drug is ineligible for donation; and

(j) Any other standards and procedures the Board considers appropriate.