Though the FDA had indicated previously that it would not extend the deadline for full implementation of Drug Supply Chain Security Act (DSCSA) requirements, discretion appears to have become the better part of valor. On June 13, 2024, we posted a blog about waivers that would be available for certain small dispensers, and yesterday the FDA expanded the exemptions to certain connected trading partners.
Apparently, the FDA did listen to stakeholders as the November 2025 deadline approached and the exemption represents “part of the agency’s broader efforts to avoid supply chain disruptions and ensure patients will not face delays in receiving the medicines they need.” The notice about the new changes can be found here.
The FDA notes that the duration of the exemption varies depending on the eligible trading partners:
- Manufacturers and Repackagers: May 27, 2025
- Wholesale Distributors: August 27, 2025
- Dispensers with 26 or more full-time employees: November 27, 2025
The Agency also says, “Trading partners who utilize these exemptions do not need to notify FDA.”
It is clear that the Agency wants firms to move forward as quickly as possible on the progress already made by all trading partners, and also that the FDA does not want to take an action that could cause disruptions to the nation’s drug supply. It is reassuring to know that, at least in this case, the FDA made a reasoned decision based on feedback on the state of readiness, or lack thereof, of its stakeholders to avoid a potentially tumultuous event as the industry inches toward full compliance with the DSCSA.
