Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry; Availability

Resumen

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers." The guidance is intended to address questions regarding product identifiers that, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Drug Supply Chain Security Act (DSCSA), are required to be affixed to, or imprinted on, packages and homogenous cases of certain drug products intended to be introduced in a transaction into commerce. This guidance is intended to clarify FDA's interpretation of these requirements, including as they relate to the linear barcode requirements under the Code of Federal Regulations. This guidance finalizes the draft guidance issued on September 20, 2018.