Earlier this month, the FDA announced that it will be granting exemptions from certain drug distribution security requirements under the Drug Supply Chain Security Act (DSCSA) to eligible trading partners.
These exemptions apply to partners who have tried to establish data connections but still face challenges in data exchange. The move aims to prevent supply chain disruptions and ensure patients have continued access to essential medications.
Here's a look at the exemptions.
- For drug manufacturers and repackagers, the exemption will be in place until May 27, 2025, while wholesalers have until August 27, 2025, to comply.
- Dispensers with 26 or more full-time employees have a deadline of November 27, 2025. Small dispensers, defined as those with 25 or fewer employees, are exempt from certain requirements until November 27, 2026.
- Trading partners utilizing these exemptions are not required to notify the FDA.
These exemptions provide drug manufacturers and other trading partners additional time to fully implement the enhanced DSCSA requirements, including establishing electronic data systems.
Trading partners that do not qualify for these exemptions may request waivers or additional exemptions, but they must continue efforts to meet DSCSA requirements until the FDA responds to their requests.
The DSCSA sets forth a process for creating an electronic, interoperable system to track and trace prescription drugs at the package level as they move through the supply chain. This system helps prevent harmful drugs from entering the U.S. supply chain, detects any dangerous drugs that do enter, and facilitates quick action to remove them, ensuring patient safety.
