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Drug Supply Chain Security Guidance

06/11/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. The guidance addresses new provisions in the FD&C Act, as amended by the Drug Supply Chain Security Act. It is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and terminating notifications for illegitimate product. It also identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable; and for product that has been determined to be illegitimate, or (for manufacturers) has a high risk of illegitimacy, sets forth the process by which trading partners should notify FDA of illegitimate product and how they must terminate the notifications, in consultation with the agency. To view this notice, click here.

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