FDA issues guidance for industry on wholesale distributor verification requirement for saleable returned drug product

FDA issues guidance for industry on wholesale distributor verification requirement for saleable returned drug product

FDA today announced the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product--Compliance Policy."

This guidance announces FDA’s compliance policy regarding the Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned drug products.

Given 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 one-year delay in enforcement of this DSCSA requirement. This compliance policy does not extend to the other requirements that will take effect on November 27, 2019.