6 Things We Need From FDA Before Full 2023 DSCSA Enforcement
By Mike Karhoff and Mark Karhoff, Ten Count Consulting, LLC
The journey to industry compliance with the U.S. Drug Supply Chain Security Act (DSCSA) continues to twist and turn with recent requirements going into effect for distributors and dispenser and subsequent delays on enforcement of some of those requirements until Nov. 27, 2023. While the FDA did well to respond to requests for delays in enforcement, the postponement does not remove the active requirements of the law, and stakeholders should continue to work towards ensuring compliance and documenting their efforts in the event of potential FDA inquires or investigations. It is important to continue working on these systems and communicating with trading partners to mitigate risk and take advantage of the opportunity to stabilize systems, processes, and data.