Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry; Availability

Resumen

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs." This guidance identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. This guidance finalizes the revised draft guidance of the same title, "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs," issued in July 2022, as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).