2023-05359: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act." The guidance is intended to help industry better understand the definitions of "suspect" and "illegitimate" product as defined in the Drug Supply Chain Security Act (DSCSA). The guidance lays out FDA's current understanding of the following key terms used to define "suspect" and "illegitimate" product: "counterfeit," "diverted," "stolen," "fraudulent transaction," and "unfit for distribution." The guidance finalizes the draft guidance entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act" issued on June 4, 2021.
The agency’s own summary, as published.
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