N.J. Admin. Code § 8:32-2.1

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:32-2.1 - Applying for authorization

(a) An entity may at any time apply with the Department for authorization to establish and maintain a drug donation program.

(b) To apply, the entity must complete the Drug Donation Application (DDP-1) which is available on the Department's website at https://healthapps.state.nj.us/forms/ and submit it with a program proposal to DrugDonation@doh.nj.gov.

(c) A program proposal should include the following information:

1. A description of the entity, including its history, mission, ownership structure, size, staff, and any characteristics that demonstrate the organization's ability to effectively establish a drug donation program;

2. Standards and procedures for accepting, transporting, safely storing, and dispensing donated drugs and/or administration supplies;

3. 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;

4. Standards and procedures for inspecting donated drugs to ensure that the drugs are not adulterated or misbranded;

5. Standards and procedures for preventing diversion;

6. Standards and procedures for calculating donor tax credits;

7. Eligibility criteria for individuals to receive donated drugs and administration supplies dispensed pursuant to the drug donation program, which ensures those receiving donated drugs are indigent, uninsured, or enrolled in a public health benefits program, or 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;

8. A list of over-the-counter drugs and prescription drugs that the program is seeking, willing to accept, and not willing to accept; and

9. A detailed list of all position titles that will come into contact with donated drugs, and the oversight they are under.

(d) The Department, in consultation with the Board, will review the program proposal and may either:

1. Approve the program proposal and grant authorization;

2. Request amendments as a condition of authorization; or

3. Reject the program proposal and not grant authorization.

(e) If the Department approves the program proposal and grants authorization, the entity must strictly abide by the approved standards and procedures in the approved program proposal.

(f) If the entity wishes to amend the approved standards and procedures, it must first notify the Department of the proposed amendments through email at DrugDonation@doh.nj.gov, and receive approval to make the desired amendments.

(g) If the name, address, or contact information of the entity changes, the organization must submit the updated information to the Department through email at DrugDonation@doh.nj.gov, not later than 30 days after the change occurs.

(h) If an entity intends to close or cease operations, the entity must first report the closure or cessation of operations to the Department through email at DrugDonation@doh.nj.gov, no later than 30 days prior to said closure or cessation and must submit and receive approval for a plan to maintain records as required pursuant to this chapter, as well as plans for destroying any excess inventory of donated drugs.

(i) An entity must submit a new program proposal and get approval to resume its drug donation program if it has ceased operations.

N.J. Admin. Code § 8:32-2.1

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