This draft guidance describes FDA’s intention with regard to the enforcement of certain requirements related to product identifiers under the Drug Supply Chain Security Act. Specifically, this draft guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” beginning not later than November 27, 2017. A drug product is misbranded if it fails to bear the product identifier as required by section 582 of the FD&C Act. This draft guidance also addresses the requirements in section 582(b)(4) of the FD&C Act that, beginning November 27, 2017, manufacturers must: (1) use the standard numerical identifier, which is part of the product identifier, to verify product at the package level, when investigating suspect product or upon receiving a verification request from
FDA; (2) verify the product identifier of product in the possession or control of an authorized repackager, wholesale distributor, or dispenser who believes that such product was manufactured by the manufacturer and who submits a request for verification to the manufacturer, and (3) verify the product identifier on each package or sealed homogenous case of such product that they intended to further distribute as a saleable return. In addition, this draft guidance addresses the requirements for wholesale distributors, dispensers, and repackagers related to engaging in transactions involving product with a product identifier12 and product verification. Lastly, this draft guidance addresses the requirements for wholesale distributors and repackagers related to saleable returns.