Friday, December 9, 2016

DSCSA Identification of Suspect Product and Notification - FDA Final Guidance

The FDA released this final guidance:
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification FDA Guidance for Industry (PDF)

In brief:
This guidance 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 a product and determine whether a product is a suspect product as soon as practicable; and sets forth the process by which trading partners should notify FDA of illegitimate product or products with a high risk of illegitimacy, and how they must terminate the notifications, in consultation with FDA.

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