This morning, the FDA published a revision to the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies guidance originally issued in draft in 2019 and then finalized in 2020. The revision provides for another one-year delay in enforcement for the […]
For months (if not years), we have been hearing alarms from industry trading partners who are subject to requirements for enhanced drug distribution security under section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law […]
Today, the FDA issued a draft guidance titled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act (here). The various terms fall under the general areas identified in the DSCSA as Suspect Product and Illegitimate Product, and this guidance will help clarify how to further identify and […]
