With just months to go before the implementation of the Drug Supply Chain Security Act’s (DSCSA) enhanced verification provisions go into effect, the FDA has finalized a key guidance containing definitions of essential terms needed for companies to ensure compliance with the law, including which products would be “unfit for distribution” or be considered “diverted.” The final guidance also makes several key changes that address – and may alleviate – prior industry concerns.
Background on the Drug Supply Chain Security Act
The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.
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