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The FDA recently published guidance to help the pharma industry detect suspicious and illegitimate products within the pharmaceutical supply chain. These regulations, established under the Drug Supply Chain Security Act (DSCSA), concentrate on product tracing, verification, and identification for specific drug products distributed in the U.S.So far this year, the agency has released more than a dozen guidance documents related to the development of new drugs, the use of pharmacogenomic data in drug submissions, quality considerations for cannabis-derived compounds and clinical trials for drug and biologics.
Here, we summarize the guidance on suspicious and illegitimate products, clarifying the interpretation of terms such as counterfeit, diverted, stolen, fraudulent transaction and unfit for distribution, as defined in section 581 of the FD&C Act (21 U.S.C. 360eee). Read more