S2560

An Act authorizing the establishment of drug donation programs, 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 the State can be improved, and the cost to the State of providing health care to low-income persons can be reduced, through the establishment of one or more programs that provide for: the donation of unused over-the-counter drugs, prescription drugs, and administration supplies, which would otherwise be destroyed; and the redistribution of such unused drugs and administration supplies to those persons who are most in need.

2. As used in this act:

“Administration supplies” means any supply associated with the administration of prescription drugs, including, but not limited to, diabetes test strips, nebulizers, syringes, and needles.

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

“Board” means the State Board of Pharmacy.

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

“Commissioner” means the Commissioner of Health.

“Controlled dangerous substance” means the same as that term is defined by N.J.S.2C:35-2.

“Donated drug” means an over-the-counter drug or prescription drug that has been donated to a redistributor in accordance with the provisions of this act.

“Donor” means a drug manufacturer, wholesaler, repackager, or reverse distributor, or a health care facility, correctional facility, pharmacy, or any other person or entity that is properly licensed and authorized to possess prescription drugs, and which elects to donate over-the-counter drugs, prescription drugs, or administration supplies pursuant to this act.

“Drug donation program” means a program, established pursuant to the provisions of this act, which accepts the donation of unused over-the-counter drugs, prescription drugs, and administration supplies that would otherwise be destroyed, and which provides for the redistribution of those unused drugs and administration supplies to persons who are most in need.

“Health care facility” means a physician’s office; a hospital; an outpatient clinic; a federally qualified health center; a federally qualified health center look-alike; a rural health clinic; a disproportionate share hospital; a clinic that provides services under the federal Ryan White HIV/AIDS Program; a mental health center or clinic; and any other health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.), or a comparable facility licensed to operate within another state.

“Indigent” means a person that has an income that is below 250 percent of the federal poverty level.

“Prescriber” means a licensed physician, physician assistant, or advanced practice nurse, or any other person who is authorized by the appropriate State professional and occupational licensing board to prescribe drugs and devices as provided by law. “Prescription drug” means any drug, intended for use in humans, which is required by federal or State law or regulation to be dispensed only pursuant to a prescription. “Prescription drug” includes cancer drugs and anti-rejection drugs, but does not include any controlled dangerous substance.

“Redistributor” means a health care facility, pharmacy, or any other person or entity that is properly licensed and authorized to dispense over-the-counter drugs and prescription drugs, and which agrees to accept, repackage, transfer, and dispense donated drugs and administration supplies to eligible individuals, or to other redistributors, pursuant to this act.

“Out-of-State redistributor” means a health care facility, pharmacy, or other person or entity that is properly licensed to operate in a state other than New Jersey, and is authorized to dispense over-the-counter drugs and prescription drugs, and which agrees to accept, repackage, transfer, and dispense donated drugs and administration supplies to eligible individuals, or to other redistributors, pursuant to a prescription drug donation program established under the laws of the state in which the person or entity is located.

“Tamper-evident packaging” means a package or container that has an immediate, outer, or secondary seal that must be broken in order to gain access to the container’s contents.

“Third-party intermediary” means an organization that is not a wholesaler or third-party logistics provider, and that facilitates the donation or transfer of over-the-counter drugs, prescription drugs, and administration supplies for a drug donation program established pursuant to this act, but which does not take possession or ownership of the drugs.

3. a. No later than six months after the enactment of this act, the commissioner, in cooperation with the board, shall authorize one or more private entities to establish and maintain a drug donation program, pursuant to which a donor may donate over-the-counter drugs, prescription drugs, and administration supplies to a redistributor for final dispensing to an individual who meets the eligibility criteria established by the entity for the purposes of its program.

b. An entity that establishes a drug donation program pursuant to this act may contract with a third-party intermediary to implement and administer the program.

c. An entity that establishes a drug donation program pursuant to this act shall develop, implement, and make available, upon request of the commissioner, the board, or the public:

(1) standards and procedures for accepting, safely storing, and dispensing donated drugs and administration supplies;

(2) standards and procedures for inspecting donated drugs to ensure that the drugs are contained in sealed, tamper-evident packaging, including, but not limited to, intact single-unit doses or blister packs;

(3) standards and procedures for inspecting donated drugs to ensure that the drugs are not adulterated or misbranded;

(4) eligibility criteria for individuals to receive donated drugs and administration supplies dispensed under the program, which criteria shall prioritize the dispensing of donated drugs and administration supplies to individuals who are indigent, uninsured, or enrolled in a public health benefits program, but may permit dispensing to other individuals if a need for the donated drugs and administration supplies is not identified among persons who are indigent, uninsured, or enrolled in a public health benefits program;

(5) a means by which an individual may indicate their eligibility to receive donated drugs and administration supplies under the program;

(6) a list of over-the-counter drugs and prescription drugs that the program is seeking, will accept, and will not accept, including a list of those drugs that an individual redistributor participating in the program is seeking, will accept, and will not accept;

d. Donated over-the-counter drugs, prescription drugs, and administration supplies may be transferred from one redistributor to another redistributor in this State, and may be transferred to or from a redistributor in another state, provided that such transfer is permitted under the laws of that state. The donation, transfer, or facilitation of donations and transfers of over-the-counter drugs or prescription drugs pursuant to this subsection shall not be deemed to constitute wholesale distribution.

e. (1) Any over-the-counter drugs and prescription drugs that a donor legally possesses, including, but not limited to, over-the-counter drugs and prescription drugs that are discontinued in a health care facility, and that would otherwise be destroyed, are eligible for donation under this act.

(2) A prescription drug that can only be dispensed to a patient who is 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 by any drug donation program.

f. A common carrier or contract carrier may be used to transport donated over-the-counter drugs, prescription drugs, and administration supplies, in accordance with manufacturer recommendations, from a donor to a redistributor, from a redistributor to another redistributor, or from a redistributor to an eligible patient.

g. The participation of any person, facility, or other entity in a drug donation program established under this act shall be voluntary.

4. a. Donated drugs and administration supplies may be accepted, transferred, and dispensed by a redistributor pursuant to this act, provided that the following conditions are satisfied:

(1) the donated drugs are not expired, and are contained in a sealed and tamper-evident package, including, but not limited to, a single-unit dose or blister pack that remains intact;

(2) the donated drugs and administration supplies are dispensed to an eligible individual by a pharmacist or other health care professional who is authorized by law to dispense over-the-counter drugs and prescription drugs;

(3) the dispensing pharmacist or other health care professional determines, prior to dispensing a donated drug, that the donated drug is not adulterated or misbranded; and

(4) the dispensing pharmacist or other health care professional dispenses any donated prescription drugs or prescription administration supplies to eligible individuals only pursuant to a valid prescription.

b. A redistributor may accept over-the-counter drugs, prescription drugs, and administration supplies from a donor located in another state, provided that the transfer is permitted under the laws of that other state.

c. A redistributor may repackage donated over-the-counter drugs, prescription drugs, or administration supplies before transferring, storing, or dispensing the donated drugs or administration supplies to an eligible individual, or before transferring the donated drugs or administration supplies to another redistributor.

d. Donated drugs and administration supplies shall be segregated from other drug stocks, by either physical or electronic means.

e. (1) A redistributor’s receipt of reimbursement or payment from another redistributor, a governmental agency, a pharmacy benefit manager, a pharmacy services administration organization, or a health care coverage program under this section shall not be deemed to constitute the resale of prescription drugs for the purposes of this act, or for the purposes of any other law or regulation.

(2) A redistributor may charge a handling fee to an eligible individual who is dispensed a donated drug pursuant to this act, provided that the fee does not exceed the reasonable costs of procuring, transporting, inspecting, repackaging, storing, and dispensing the donated drug. The redistributor shall maintain a record validating the charge, and shall make that record available to the department, upon request.

f. (1) If a donor receives notice from a pharmacy or pharmaceutical manufacturer regarding the recall of a donated over-the-counter drug or prescription drug, or of donated administration supplies, the donor shall provide notice of the recall to the redistributor who received the recalled over-the-counter drug, prescription drug, or administration supplies, unless the redistributor has provided the donor with a written statement attesting that the redistributor receives recall notices for all transferred and dispensed drugs through other means.

(2) If a redistributor receives notice of a recall pursuant to paragraph (1) of this subsection, the redistributor shall provide notice of the recall to any other redistributor to whom it has transferred the recalled over-the-counter drugs, prescription drugs, or administration supplies, unless the secondary redistributor has provided the primary redistributor with a written statement attesting that the secondary redistributor receives recall notices for all transferred and dispensed drugs through other means.

(3) Any redistributor who receives a notice of recall shall perform a uniform destruction of all of the recalled over-the-counter drugs, prescription drugs, or administration supplies in its possession.

5. A donor shall be allowed a credit against the tax that would otherwise be due under the “New Jersey Gross Income Tax Act,” P.L.1976, c.47 (C.54A:1-1 et seq.), for the taxable year in which a donation was made pursuant to this act, in an amount equal to the cost of any over-the-counter drugs, prescription drugs, and administration supplies that were donated during the taxable year, provided that:

a. the donor paid for, owned, or was responsible for, the over-the-counter drugs, prescription drugs, or administration supplies; and

b. the over-the-counter drugs, prescription drugs, or administration supplies were donated to, and accepted by, a redistributor in accordance with the provisions of this act.

6. a. Any donor, redistributor, third-party intermediary, common carrier, contract carrier, governmental agency, pharmacy benefit manager, pharmacy services administration organization, health care coverage program, or other person or entity who acts reasonably and in good faith, within the scope of a drug donation program, and in accordance with the provisions of this act, shall be: (1) immune from civil or criminal liability for any injury, death, or loss suffered by a person who is dispensed a donated drug, or donated administration supplies under this act; and (2) exempt from any professional disciplinary action stemming from any act or omission associated with the donation, acceptance, transfer, or dispensing of a donated drug or donated administration supplies pursuant to this act.

b. A drug manufacturer or wholesaler who acts 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 stemming from any act or omission in association with the donation, acceptance, transportation, or dispensing of an over-the-counter drug or prescription drug that is manufactured or distributed by the drug manufacturer or wholesaler and donated pursuant to this act, including any liability resulting from a failure to transfer or communicate product or consumer information or the expiration date of the donated drug.

c. A redistributor who dispenses donated drugs or administration supplies that have been recalled shall be immune from civil or criminal liability for any injury, death or loss suffered by a person who is dispensed those drugs or administration supplies, provided that the redistributor was not notified of the recall by the donor, by another redistributor, or through other means, as provided in subsection g. of section 4 of this act.

7. The provisions of this act shall not be construed to restrict the use of drug samples by a health care professional who is licensed to prescribe drugs and devices during the course of the professional’s duties at a health care facility or pharmacy.

8. Not later than six months after the date of enactment of this act, the commissioner, in consultation with the board, shall adopt rules and regulations, pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), as may be necessary to effectuate the purposes of this act.

9. This act shall take effect on the 180th day next following the date of enactment, except that the Commissioner of Health and the Director of the State Board of Pharmacy may take such anticipatory administrative action in advance thereof as shall be necessary for the implementation of this act.

STATEMENT

This bill would allow private entities to voluntarily establish drug donation programs, pursuant to which health care facilities, pharmacies, pharmaceutical manufacturers, and similar entities will be permitted to donate over-the-counter drugs, prescription drugs, and administration supplies for use by people who are indigent, uninsured, or underinsured. An entity electing to establish a drug donation program may contract with a third-party intermediary to implement and administer the program.

The bill would provide, in particular, that drug manufacturers, wholesalers, repackagers, and reverse distributors, as well as health care facilities and pharmacies, will be permitted to donate unexpired over-the-counter and prescription medications that are contained in tamper-evident packaging, or sealed in intact single-dose units or blister packaging. The bill would permit the donation of such over-the-counter and prescription medications as cancer drugs, anti-rejection drugs, and drugs that have been discontinued in a health care facility, but it would not permit the donation of controlled dangerous substances, or prescription drugs that can only be dispensed to a patient who is registered with the drug manufacturer. The bill would provide that donations may be accepted from donors located in another state, provided that the donation is permitted under the laws of that other state. It would further provide that drug donors will be allowed a credit against their State gross income taxes in an amount that is equal to the cost of the drugs that were donated during the taxable year.

Under the bill’s provisions, drugs and supplies are to be donated to redistributors, including health care facilities and pharmacies. Redistributors will be required to inspect the donated drugs to determine whether they have been adulterated or misbranded, and would be required to separate any donated drugs from other drug stocks. Redistributors would be permitted to repackage donated drugs, or transfer donated drugs and administration supplies to another redistributor. Donated drugs and administration supplies may be transferred to, and accepted from, redistributors located in another state, provided that the transfer is permitted under a drug donation program established in that other state.

Redistributors will be required to establish eligibility criteria for individuals to receive donated over-the-counter drugs and prescription drugs, with priority being granted to persons who are indigent, uninsured, or underinsured. Donated drugs may not be resold by any person or entity, including a redistributor; however, redistributors are authorized by the bill to charge a reasonable handling fee to individuals who are dispensed a donated drug. The handling fee may not exceed the actual validated cost of transporting, inspecting, repackaging, storing, and dispensing the over-the-counter drug or prescription drug.

The bill would specify that donated prescription drugs may only be dispensed, pursuant to a valid prescription, by a pharmacist or other health care professional who is authorized by law to dispense prescription medications.

The bill provides that, whenever a donor receives a recall notice for a donated drug, the donor is to provide notice of the recall to any redistributor to whom it donated the recalled drug, unless the redistributor has provided the donor with a written statement attesting that the redistributor receives such recall notices through other means. In the same respect, if a redistributor has transferred a donated drug to another redistributor, and the drug is later recalled, the primary redistributor will be required to notify secondary redistributors of the recall, unless the secondary redistributors have provided a written statement attesting that they receive recall notices through other means. Upon receiving notice of a recall, whether from a donor, a redistributor, or through other means, a redistributor will be required to perform a uniform destruction of all the recalled drugs in their possession.

Any person or entity establishing a drug donation program under the bill’s provisions will be required to: (1) develop, implement, and make available to the Commissioner of Health, the Board of Pharmacy, and members of the public, upon request, standards and procedures for meeting the requirements of the bill; and (2) develop, and make available, a list of over-the-counter drugs and prescription drugs that the program is seeking, accepting, or not accepting including, including a list of over-the-counter drugs and prescription drugs that an individual redistributor participating in the program is seeking or will not accept.

Any person or entity that acts reasonably, and in good faith, in accordance with the provisions of the bill, and within the scope of a drug donation program established thereunder, will be immune from civil and criminal liability for any injury to, or the death of, an individual to whom a donated drug is dispensed, and will similarly be exempt from disciplinary action related to any act or omission associated with a donated drug. Drug manufacturers and wholesalers will also be immune from civil or criminal liability for any injury, death, or loss related to donated drugs that they manufacture or distribute. Redistributors will be immune from civil or criminal liability for dispensing a donated drug that has been recalled, but only if the redistributor was not notified of the recall.

Nothing in the bill’s provisions would be construed to restrict the use of drug samples by a licensed prescriber during the course of the prescriber’s duties at a health care facility or pharmacy.