Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification." The guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. In addition, this guidance describes when manufacturers should notify FDA of a high risk that a product is illegitimate. This guidance responds to comments from stakeholders in order to clarify certain points and finalizes the remaining draft portion of the final guidance for industry entitled "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification," issued in December 2016.