New Jersey Administrative Code
Title 10 - HUMAN SERVICES
Chapter 167A - PROVISION OF PHARMACEUTICAL SERVICES UNDER THE PHARMACEUTICAL ASSISTANCE TO THE AGED AND DISABLED PROGRAM (PAAD)
Subchapter 1 - REQUIREMENTS FOR PROVISION OF PHARMACEUTICAL SERVICES
Section 10:167A-1.22 - Drug Efficacy Study Implementation (DESI)

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 the 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 presently 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.