FDA to introduce Wholesale Distributor Verification Requirements

Recommendation

10/11 November 2021

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The US Food and Drug Administration FDA has published a Compliance Policy Guidance for Industry "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product".

This Guidance is part of FDA's Drug Supply Chain Security Act (DSCSA) and will require wholesale distributors to verify a product identifier prior to further distributing returned product. To address concerns expressed by stakeholders and to minimize possible disruptions in the pharmaceutical distribution supply chain, FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under the DSCSA. This represents a 1-year delay in enforcement of this DSCSA requirement.