Summary

FDA Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

Author:

Monitoring and Reporting Work Group

On December 9, 2016, FDA issued guidance for industry entitled ‘‘Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.’’  This guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA).  This 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.  This guidance also includes a new section, for comment purposes only, that describes when manufacturers should notify FDA of a high risk that a product is illegitimate.  Aside from that section, this guidance is a final guidance subsequent to the draft guidance that was issued on June 11, 2014.

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