Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act." The draft guidance is intended to describe FDA's interpretation of terms used in the definitions of "suspect product" and "illegitimate product" in the Drug Supply Chain Security Act (DSCSA), for purposes of trading partners' verification obligations (including notification). The draft guidance lays out FDA's current understanding of the following key terms for such purposes: Counterfeit, diverted, fraudulent transaction, and unfit for distribution.