S2615

An Act establishing a prescription drug donation repository program and supplementing Title 24 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. The Legislature finds and declares that the health of low-income persons in this State can be improved, and the cost to the State of providing low-income persons with health care can be reduced, by establishing a program that provides for the donation of unused prescription drugs and supplies by persons, health care facilities, and pharmacies to a central repository for redistribution to medical facilities and pharmacies in order to re-dispense these medications that would otherwise be destroyed.

2. As used in this act:

“Anti-rejection drug” means a prescription drug that suppresses the immune system to prevent or reverse rejection of a transplanted organ.

“Board” means the New Jersey State Board of Pharmacy.

“Cancer drug” means a prescription drug that is used to treat cancer or the side effects of cancer, or the side effects of any prescription drug that is used to treat cancer or the side effects of cancer.

“Central repository” means a facility authorized by the State to receive and repackage donated prescription drugs and supplies to re-dispense to qualified individuals through authorized medical facilities and pharmacies.

“Commissioner” means the Commissioner of Health.

“Controlled dangerous substance” means a controlled dangerous substance as defined in N.J.S.2C:35-2.

“Department” means the Department of Health.

“Health care facility” means a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.).

“Indigent” means that a person has an income that is below 200 percent of the federal poverty level.

“Medical facility” means a physician's office, hospital, outpatient clinic, or nonprofit health clinic.

“Nonprofit health clinic” means a federally qualified health center or rural health clinic as defined in 42 U.S.C. s.1396d(l), or a nonprofit health clinic that provides medical care to patients who are indigent, uninsured, or underinsured.

“Pharmacy” means a pharmacy located in this State that is operating under a valid permit from the board.

“Prescriber” means a person authorized by the appropriate State professional and occupational licensing board to prescribe medication and devices as provided by law.

“Prescription drug” means any human drug required by federal law or regulation to be dispensed only by prescription, including dosage forms and active ingredients subject to section 503(b) of the “Federal Food, Drug and Cosmetic Act” (21 U.S.C. s.353), including cancer drugs and anti-rejection drugs, but does not include controlled dangerous substances.

“Program” means the prescription drug donation repository program established pursuant to this act.

“Repository” means the central repository established under the program, which is designated to receive all donated prescription drugs and supplies.

“Supplies” means supplies necessary to administer the prescription drugs donated under the program.

3. a. The commissioner, in cooperation with the board, shall establish and maintain a prescription drug donation repository program in the department under which a person, health care facility, or pharmacy may donate prescription drugs and supplies for use by an individual who meets eligibility criteria specified by regulation of the commissioner. All donated prescription drugs and supplies shall be sent to the repository for processing in accordance with regulations adopted by the commissioner. The department may contract with a third party to implement and administer the program.

b. Donations of prescription drugs and supplies under the program may be made on the premises of a health care facility or pharmacy that elects to participate in the program and meets the requirements established by the commissioner.

c. The medical facility or pharmacy may charge an individual who receives donated prescription drugs or supplies a handling fee that shall not exceed an amount established by the commissioner.

d. Donated prescription drugs and supplies shall not be re-dispensed without first being sent to the repository, subject to the provisions of section 4 of this act, to be repackaged and redistributed to participating medical facilities and pharmacies and, subsequently, qualified individuals in accordance with the provisions of this act.

e. The participation of any person, facility, or other entity in the program shall be voluntary.

4. a. A prescription drug or supplies may be accepted and dispensed under the program if all of the following conditions are met:

(1) the prescription drug is in its original sealed and tamper-evident packaging; however, a prescription drug in a single-unit dose or blister pack with the outside packaging opened may be accepted if the single-unit dose packaging remains intact;

(2) the prescription drug bears an expiration date that is more than six months after the date that the prescription drug was donated;

(3) the prescription drug or supplies are inspected by a pharmacist employed by the repository before the prescription drug or supplies are dispensed to a medical facility or pharmacy, in order to determine that the prescription drug or supplies are not adulterated or misbranded; and

(4) the prescription drug or supplies are prescribed by a prescriber for use by an eligible individual and are dispensed by a pharmacist.

b. A prescription drug or supplies donated pursuant to this act shall not be resold by any person, facility, or other entity.

c. (1) If a person, health care facility, or pharmacy that donates prescription drugs or supplies to the repository receives a notice from a pharmacy or pharmaceutical manufacturer that a prescription drug or supplies have been recalled, the person, health care facility, or pharmacy donating the prescription drug or supplies shall inform the repository of the recall. The repository shall notify all medical facilities and pharmacies receiving the recalled drugs or supplies of the recall.

(2) If a medical facility or pharmacy receives a recall notification from a person, health care facility, pharmacy, or the repository, the medical facility or pharmacy shall perform a uniform destruction of all the recalled prescription drugs or supplies in the medical facility or pharmacy.

d. A prescription drug dispensed through the program shall not be eligible for reimbursement under any private health care coverage or public health benefits program.

e. The commissioner shall prescribe by regulation such requirements and other aspects of the program as are necessary to effectuate the purposes of this act, including, but not limited to, the following:

(1) requirements for medical facilities and pharmacies to accept and dispense donated prescription drugs and supplies, including all of the following:

(a) eligibility criteria for participation by medical facilities and pharmacies;

(b) standards and procedures for accepting, safely storing, and dispensing donated prescription drugs and supplies;

(c) standards and procedures for inspecting donated prescription drugs to determine whether the prescription drugs are in their original sealed and tamper-evident packaging, or, if the prescription drugs are in single-unit doses or blister packs and the outside packaging is opened, whether the single-unit dose packaging remains intact; and

(d) standards and procedures for inspecting donated prescription drugs and supplies to determine that the prescription drugs and supplies are not adulterated or misbranded;

(2) eligibility criteria for individuals to receive donated prescription drugs and supplies dispensed under the program, which shall prioritize dispensing to individuals who are indigent or uninsured, but may permit dispensing to other individuals if a need for the donated prescription drugs and supplies is not identified among indigent or uninsured persons;

(3) necessary forms for administration of the program, including forms for use by individuals who donate, accept, distribute, or dispense prescription drugs or supplies under the program;

(4) a means by which an individual who is eligible to receive donated prescription drugs and supplies may indicate that eligibility;

(5) the maximum handling fee that a medical facility or pharmacy may charge for accepting, distributing, or dispensing donated prescription drugs and supplies under the program;

(6) a list of prescription drugs that the program will not accept; and

(7) criteria for any request for proposals that the department may issue to engage a third party to implement and administer the program.

5. a. A drug manufacturer acting reasonably and in good faith, in accordance with the provisions of this act and as otherwise required by law, shall be immune from civil or criminal liability for any injury, death, or loss to a person or property related to the donation, acceptance, or dispensing of a prescription drug manufactured by the drug manufacturer that is donated pursuant to this act, including liability for failure to transfer or communicate product or consumer information or the expiration date of the donated prescription drug.

b. A person other than a drug manufacturer, acting reasonably and in good faith, in accordance with the provisions of this act and within the scope of the program, shall be:

(1) immune from civil or criminal liability for any injury to, or the death of, an individual to whom a donated prescription drug is dispensed pursuant to this act, and

(2) exempt from disciplinary action related to the person's acts or omissions with respect to the donation, acceptance, distribution, or dispensing of a donated prescription drug pursuant to this act.

6. A prescription drug that can only be dispensed to a patient 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 under the program.

7. The provision of this act shall not be construed to restrict the use of samples by a prescriber during the course of the prescriber’s duties at a medical facility or pharmacy.

8. The commissioner, in consultation with the Commissioner of Human Services, shall annually issue a report to the Governor, and to the Legislature pursuant to section 2 of P.L.1991, c.164 (C.52:14-19.1), which evaluates the effectiveness of the program established pursuant to this act in providing prescription drugs and supplies, and reducing the cost of providing health care, to low-income persons in this State.

9. The commissioner, in consultation with the board and pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), shall adopt rules and regulations as necessary to effectuate the purposes of this act.

10. This act shall take effect on the first day of the seventh month next following the date of enactment, but the commissioner may take such anticipatory administrative action in advance thereof as shall be necessary for the implementation of this act.

STATEMENT

This bill establishes a prescription drug donation repository program in the Department of Health (DOH).

This program will provide for the donation of unused prescription drugs and supplies by persons, health care facilities, and pharmacies to a central repository for redistribution to authorized medical facilities and pharmacies in order to re-dispense these medications, which would otherwise be destroyed, for use by individuals who meet eligibility criteria specified by the Commissioner of Health.

The commissioner, in cooperation with the State Board of Pharmacy, is to establish and maintain the program, and DOH may contract with a third party to implement and administer the program.

Donations of prescription drugs and supplies under the program may be made on the premises of a health care facility or pharmacy that elects to participate in the program and meets the requirements established by the commissioner.

The medical facility or pharmacy may charge an individual who receives donated prescription drugs or supplies a handling fee that is not to exceed an amount established by the commissioner.

The participation of any person, facility, or other entity in the program is voluntary.

The bill stipulates that prescription drug or supplies may be accepted and dispensed under the program if:

-- the prescription drug is in its original sealed and tamper-evident packaging; however, a prescription drug in a single-unit dose or blister pack with the outside packaging opened may be accepted if the single-unit dose packaging remains intact;

-- the prescription drug bears an expiration date that is more than six months after the date that the prescription drug was donated;

-- the prescription drug or supplies are inspected by a pharmacist employed by the repository before the prescription drug or supplies are dispensed to a medical facility or pharmacy, to determine that the prescription drug or supplies are not adulterated or misbranded; and

-- the prescription drug or supplies are prescribed by an authorized prescriber for use by an eligible individual and are dispensed by a pharmacist.

A prescription drug or supplies donated pursuant to this bill is not to be resold by any person, facility, or other entity.

The bill provides that: a person, health care facility, or pharmacy that donates prescription drugs or supplies to the repository, and receives a notice from a pharmacy or pharmaceutical manufacturer that a prescription drug or supplies have been recalled, is to inform the repository of the recall; the repository is to notify all medical facilities and pharmacies receiving the recalled drugs or supplies of the recall; and the medical facility or pharmacy that receives the recall notification is to perform a uniform destruction of all the recalled prescription drugs or supplies in the medical facility or pharmacy.

A prescription drug dispensed through the program will not be eligible for reimbursement under any private health care coverage or public health benefits program.

The bill directs the Commissioner of health to prescribe by regulation such requirements and other aspects of the program as are necessary to effectuate the purposes of the bill, including, but not limited to:

-- requirements for medical facilities and pharmacies to accept and dispense donated prescription drugs and supplies;

-- eligibility criteria for individuals to receive donated prescription drugs and supplies dispensed under the program, which is to prioritize dispensing to individuals who are indigent or uninsured;

-- necessary forms for administration of the program;

-- a means by which an individual who is eligible to receive donated prescription drugs and supplies may indicate that eligibility;

-- the maximum handling fee that a medical facility or pharmacy may charge for accepting, distributing, or dispensing donated prescription drugs and supplies under the program;

-- a list of prescription drugs that the program will not accept; and

-- criteria for any request for proposals that DOH may issue to engage a third party to implement and administer the program.

The bill further directs the Commissioner of Health, in consultation with the Commissioner of Human Services, to annually issue a report to the Governor and the Legislature that evaluates the effectiveness of the prescription drug donation repository program in providing prescription drugs and supplies, and reducing the cost of providing health care, to low-income persons in this State.

The bill takes effect on the first day of the seventh month following enactment, but authorizes the Commissioner of Health to take prior administrative action as necessary for its implementation.