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a draft guidance entitled “Definitions of Suspect Product and Illegitimate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The draft guidance is intended to describe FDA's interpretation of terms used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 The draft guidance lays out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.
Posted by Dr. Tim Sandle