Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability

Zusammenfassung

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Identifying Trading Partners Under the Drug Supply Chain Security Act" (draft trading partner guidance). FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance explains how to determine when certain statutory requirements will apply to entities that may be considered trading partners in the drug supply chain. FDA is also soliciting public input specific to the activities of "private-label distributors" of drug products and whether those activities fall within the definitions under DSCSA of the various trading partners.