FDA Guide on Identifying Suspect Drug Supply

Federal Register Notice: FDA has made available a guidance on “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The document 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. It 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. Additionally, the guidance includes a new section, for comment purposes only, that describes when manufacturers should notify FDA of a high risk that a product is illegitimate. To view the guidance, click here. To view the notice, click here.