Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry

Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry this document given by FDA. The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish requirements for product tracing, verification, and product identification for certain drug products that are distributed in the United States. Many of the terms used in these requirements are defined in section 581 of the FD&C Act (21 U.S.C. 360eee).