Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

This revised draft guidance applies to the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, this draft guidance covers the statutory verification system requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. It also addresses the requirement for notification to the FDA of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, this draft guidance addresses the requirement for responding to requests for verification and processing saleable returns.