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of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability

Resumen

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act." The draft guidance is intended to help industry better understand the definitions of "suspect" and "illegitimate" product as defined in the Drug Supply Chain Security Act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 The draft guidance lays out FDA's current understanding of the following key terms used to define "suspect" and "illegitimate" product: "Counterfeit," "diverted," "stolen,"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." This revised draft guidance clarifies certain points of the draft guidance for industry "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act" issued in March 2018 (March 2018 draft guidance), including FDA's current understanding of the term "stolen."