Wholesale Distributor Verification Requirement for Saleable Returned Drug Product-Compliance Policy; Guidance for Industry; Availability

Résumé

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product--Compliance Policy." This guidance describes FDA's intention regarding enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned product beginning on November 27, 2019. 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 1-year delay in enforcement of this DSCSA requirement.