The Drug Supply Chain Security Act Implementation: Product Tracing Requirements-Compliance Policy; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "DSCSA Implementation: Product Tracing Requirements--Compliance Policy." This guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to enforce these requirements against manufacturers, wholesale distributors, and repackagers who do not, prior to May 1, 2015, provide or capture the transaction information, transaction history, and transaction statement required by the FD&C Act (product tracing information) for transaction of certain human, finished prescription drugs that are covered in the statute.