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.
Manufacturers are additionally required to notify FDA and appropriate immediate trading partners no 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.
Notifications or requests for termination of notifications can be made by sending the information using Form FDA 3911. For information about filling out the form, refer Form FDA 3911 Supplemental – Form Instructions and the Frequently Asked Questions below.
FDA has issued a draft guidance, Guidance for Industry, the Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF - 1.2MB), that addresses how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 outlines the process by which trading partners consult with FDA in order to terminate the notifications regarding illegitimate product.