FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A

Yesterday, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to help pharmaceutical trading partners understand their compliance obligations for packages and homogenous cases of product that are not labeled with a product identifier and that are in the distribution supply chain at the time of the effective date of the requirements of the DSCSA.

The FDA issued these guidances due to the FDA's decision to delay by one year - until November 27, 2018 - the FDA's enforcement of the requirement for manufacturers to affix or imprint product identifiers, known as "serialization."

Read more: FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A


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