FDA reminds manufacturers and repackagers that they should not certify that no changes have occurred for a listed drug during the annual registration renewal period if a product identifier (section 582(b)(2) and (e)(2) of the Federal Food, Drug, and Cosmetic Act) has been added to the listed drug’s packaging since the last review and update. Instead, these manufacturers and repackagers must submit a representative sample of the product labels with the product identifier to update their listing.
Federal law (section 510 of the FD&C Act and 21 CFR Part 207) requires manufacturers and repackagers that are registered with FDA report and periodically update listing information for each drug they distribute. Federal law also requires registered entities to certify their listing information is up to date between October 1 and December 31 each year.
See Drug Supply Chain Security Act and Drug Registration and Listing System (DRLS and eDRLS) for more information.