FDA: Additional Time to Refine Systems and Processes for Interoperable Electronic Tracing

Effective August 25, 2023: FDA issues new compliance policies to help supply chain stakeholders attain enhanced traceability under DSCSA.

FDA recognizes that additional time beyond November 27, 2023 is necessary to “stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.”

FDA is issuing this compliance policy to provide additional time, beyond November 27, 2023, to attain compliance without hindering access to prescription pharmaceuticals.

While FDA is strongly urging supply chain stakeholders to continue their efforts to deploy enhanced traceability solutions, FDA does not intend to take action to enforce enhance drug traceability until November 27, 2024.

Per FDA:

“This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.”

> Read Updated FDA Guidelines