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 provision of track and trace for resalable returned product and verification of a suspect or illegitimate product. The full guidance can be found here.
The issuance of this revised guidance comes right on the heels of the revision of the Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies Guidance for Industry (here), which was the subject of a previous blog post (here). This CPG deals with other aspects of the DSCSA for which the Agency also announced a one-year delay for full compliance.
The FDA hopes that the delay in enforcement of these provisions will allow trading partners to have the necessary systems in place and have sufficient time to ensure the interoperability of those systems.
