The Drug Supply Chain Security Act (DSCSA) requires certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers), to notify FDA and all appropriate immediate trading partners not later than 24 hours after making the determination that a product is illegitimate beginning January 1, 2015.
Manufacturers are additionally required to notify FDA and appropriate immediate trading partners not later than 24 hours after the manufacturer determines or is notified by FDA or a trading partner that there is a high risk that a product is illegitimate. The DSCSA also requires that manufacturers, repackagers, wholesale distributors, and dispensers consult with FDA before terminating the notification about an illegitimate product.
FDA has issued a draft guidance, Guidance for Industry, the Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF - 1.2MB), that addresses how trading partners should notify FDA about illegitimate products. In addition, this guidance sets forth the process by which trading partners consult with FDA in order to terminate the notifications regarding illegitimate product.
FDA is soliciting comments from interested stakeholders about this guidance until for 60 days following the publication date. For instructions on how to submit comments, see the Federal Register notice.
Notifications or requests for termination of notifications can be made by sending the information outlined in the guidance to DrugNotifications@fda.hhs.gov.