N.J. Admin. Code § 8:32-4.1

Current through Register Vol. 56, No. 24, December 18, 2024

Section 8:32-4.1 - Conditions

(a) Donated drugs and administration supplies may be accepted, transferred, and dispensed by a redistributor, provided that the following conditions are satisfied:

1. The donated drugs are contained in a sealed and tamper-evident package 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 who is authorized by law to dispense over-the-counter drugs and prescription drugs determines, prior to dispensing a donated drug, that the donated drug is not adulterated or misbranded;

4. The dispensing pharmacist or other health care professional who is authorized by law to dispense over-the-counter drugs and prescription drugs dispenses any donated prescription drugs or prescription administration supplies to eligible individuals only pursuant to a valid prescription;

5. The dispensed drugs and administration supplies are in a new container or have had all previous individual information on the donated container redacted or removed and destroyed;

6. The dispensed drugs and administration supplies are properly labeled, in accordance with the rules of the Board;

7. The dispensed drugs and administration supplies have a beyond use date brought forward from the donated drug that will not expire before the use by the individual based on the prescribing practitioner's directions for use or, for over-the-counter drugs, on the package's label; and

8. An out-of-State redistributor complies with all laws and rules in this State unless such laws or rules differ or conflict with the laws or rules of the state in which the redistributor is located.

(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 pursuant to the laws of the 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) Repackaged drugs shall be labeled with the drug name, strength, and beyond use date, and shall be kept in a separate designated area until inspected and initialed by a pharmacist or other health care professional who is authorized by law to dispense over-the-counter drugs and prescription drugs.

(e) If multiple packaged donated drugs with varied beyond use dates are repackaged together, the soonest beyond use date shall be used.

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

(g) 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 pursuant to this section, including a usual and customary charge, shall not be deemed to constitute the resale of prescription drugs for the purposes of this chapter, or for the purposes of any other law or rule.

(h) A redistributor may also charge a handling fee to an eligible individual who is dispensed a donated drug pursuant to this chapter, provided that, if the redistributor is for-profit, the fee does not exceed the reasonable costs of procuring, transporting, inspecting, repackaging, storing, and dispensing the donated drug. A redistributor that charges a handling fee pursuant to this subsection shall maintain a record validating the charge and shall make that record available to the Department upon request.

(i) 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.

(j) If a redistributor receives notice of a recall pursuant to (i) above, 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 subsequent redistributor has provided the previous redistributor with a written statement attesting that the subsequent redistributor receives recall notices for all transferred and dispensed drugs through other means.

(k) 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.

(l) Prior to the first donation from a new donor, a redistributor shall verify and record the following as a donor record, and no other donor information shall be required:

1. The donor meets the definition of donor pursuant to this chapter;

2. The donor's name, address, phone number, and license number (if applicable);

3. Certification that the donor will not donate any controlled dangerous substances;

4. Certification that the donor owns the drugs and it is not under legal or has a contractual obligation to return the donated drugs to another party;

5. Certification that the donor has stored the drugs, in accordance with manufacturer's recommendations or instructions; and

6. Certification that, if applicable, the donor will remove or redact any names of individuals and/or prescription numbers on donated drugs or otherwise maintain confidentiality by executing a confidentiality agreement with the redistributor.

(m) A drug manufacturer, repackager, pharmacy, or wholesaler other than a returns processor participating in the drug donation program, shall comply with the requirements at 21 U.S.C. §§ 360eee-1 through 360eee-4, relating to drug supply chain security.

(n) If a redistributor does not accept donated drugs and administration supplies, the redistributor shall dispose of those items by returning the drugs or supplies to the donor, destroying the drugs or supplies by an incinerator or other lawful method, or transferring them to a returns processor. A redistributor shall maintain a record of disposed drugs and administration supplies, which shall consist of the disposal method, as described above, the date of disposal, and the name, strength, and quantity of each drug disposed, and the name and quantity of any administration supplies disposed. No other record of disposal shall be required.

(o) All donated drugs and administration supplies received, but not yet accepted into inventory, shall be kept in a separate designated area. Prior to or upon accepting a donation or transfer into inventory, a redistributor shall maintain a written or electronic inventory of the donation, consisting of the transaction date, the name, strength, and quantity of each accepted drug and the name and quantity of any accepted administration supplies, and the name, address, and phone number of the donor. This record shall not be required if the two parties are under common ownership or common control. No other record of donation shall be required.

(p) Once the redistributor examines the drugs and formally accepts them, the drug donation program will provide a receipt detailing the transaction to the donor. The redistributor must retain an identical copy of the receipt for a period of four years. The Division may request a copy during this time. After the retention period of four years, the receipt may be destroyed. The receipt shall include the following information:

1. Transaction date;

2. Any charges imposed by the distributor for accepting the drugs or supplies;

3. The name, strength, quantity, and cost to the taxpayer of each accepted drug;

4. The name, quantity, and cost to the taxpayer of any accepted administration supplies;

5. The name, Social Security or Federal tax ID number, address, and phone number of the donor; and

6. The total calculated tax credit. The drug donation program's calculation and certification of the total amount of tax credit to be allowed to the donor, based on the donor's cost of the accepted drugs and administration supplies, plus any charges that the drug donation program imposes for accepting the donation.

(q) An authorized recipient shall maintain the donated drugs pursuant to adequate storage conditions, including proper lighting, ventilation, and temperature control, as recommended by the drug manufacturer. If storage conditions are not specified by the drug manufacturer, the prescription drug or chemical shall be maintained according to the parameters set forth in the Drug Substance Monographs and Excipients of the United States Pharmacopeia/National Formulary, 2022 edition, incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia/National Formulary website at www.usp.org. Where no specific directions or limitations are provided in the packaging and storage section of individual monographs or in the manufacturer specifications, the conditions of storage shall include storage at a temperature maintained thermostatically between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit), protection from moisture, and, where necessary, protection from light.

(r) All records required pursuant to this section shall be retained in physical or electronic format, on or off the redistributor's premises for a period of six years. A donor or redistributor may contract with one another or a third-party entity to create or maintain records on each other's behalf. An identifier, such as a serial number or barcode, may be used in place of information required by a record or label pursuant to this rule if it allows for such information to be readily retrievable. An identifier shall not be used on drug labels when dispensing or administering a drug.

(s) If a record of the transaction information or history of a donation is required, the history shall begin with the acceptance of the drugs, shall include all prior donations, and, if the drug was previously dispensed, shall only include drug information required to be on the drug label, in accordance with Board rules.

N.J. Admin. Code § 8:32-4.1

Adopted by 56 N.J.R. 1793(a), effective 9/3/2024