Final Guidance Containing Definitions Relevant to DSCSA Released by FDA 

Food and Drug Administration (FDA) released the final guidance document, Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act, as part of the preparation for implementation of the Drug Supply Chain Security Act (DSCSA). The terms “counterfeit,” “diverted,” “stolen,” “fraudulent transaction,” and “unfit for distribution” are clarified in the definitions of “suspect product” and “illegitimate product” to help trading partners in meeting verification obligations. This guidance replaces the previous draft guidance of the same name.