N.J. Admin. Code § 10:51-1.21

Current through Register Vol. 56, No. 11, June 3, 2024

Section 10:51-1.21 - Drug Efficacy Study Implementation (DESI)

(a) "Less than effective drugs" are subject to a Notice of Opportunity for Hearing (NOOH) by the Food and Drug Administration (FDA).

1. Reimbursement is not available for the purchase or administration of any drug product that meets all of the following conditions:

i. The drug product was approved by the Food and Drug Administration (FDA) before October 10, 1962;

ii. The drug product is available only through prescription;

iii. The drug product is the subject of a NOOH issued under Section 505(e) of the Federal Food, Drug, and Cosmetic Act and published in the Federal Register on a proposed order of FDA to withdraw its approval for the drug product because it has determined that the product is less than effective for all its labeled indications; and

iv. The drug product is at present the subject of an efficacy review study performed by FDA (see 21 CFR 310.6 including all subsequent amendments and supplements). The FDA efficacy review potentially can determine justification for a drug product's medical need. If a drug product fails this review, the product is classified as a DESI drug.

2. Reimbursement is not available for the purchase or administration of any drug product that is identical, related or similar, as defined in 21 CFR 310.6 (including all subsequent amendments and supplements), to a drug product that meets the conditions of (a) above.

3. The initial identification of drugs and related drug products classified as "less than effective" by the FDA pending outcome of the NOOH appears at 21 CFR 310.6. Subsequent revisions that are adopted shall appear in the Federal Register.

N.J. Admin. Code § 10:51-1.21

Amended by 48 N.J.R. 2785(a), effective 12/19/2016