FDA is issuing an exemption from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners. This exemption applies to any product transacted by eligible trading partners, which are trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data.
This exemption is 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.
FDA is committed to ensuring patient access to medicines and avoiding supply chain disruptions while continuing significant progress toward full implementation of Drug Supply Chain Security Act (DSCSA) requirements.
While much progress has been made, including establishing electronic system data connections, this exemption is intended to support continued implementation of DSCSA without disrupting patient access to their medications .
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
Trading partners who utilize these exemptions do not need to notify FDA.
FDA Grants Exemptions to Small Dispensers
FDA is issuing exemptions from certain requirements of section 582 of the FD&C Act to small dispensers (pharmacies), and where applicable their trading partners, until November 27, 2026. This provides small dispensers additional time to stabilize their operations to fully implement the enhanced drug distribution security requirements of the Drug Supply Chain Security Act (DSCSA).
A dispenser is considered a small dispenser, for the purposes of these exemptions, if, as of November 27, 2024, the company that owns the dispenser has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians. Pharmacies must make their own determination of whether they meet the definition of a small dispenser.
FDA urges small dispensers to continue their efforts to implement the necessary measures to comply with the enhanced drug distribution security requirements. Small dispensers and their trading partners who utilize these exemptions do not need to submit anything to FDA or inform the agency.
Requesting a Waiver or Exemption Beyond the Stabilization Period
Trading partners that do not qualify for the exemptions above and are unable to meet the enhanced drug distribution security requirements of section 582 of the FD&C Act by November 27, 2024, may request a waiver, exception, or exemption from those requirements. The agency will make every effort to respond to the waiver, exception, or exemption request by November 27, 2024.
A trading partner’s obligation to comply with enhanced drug distribution security requirements by November 27, 2024, will not be paused or extended upon submission of a request or while FDA’s response is pending. The agency expects the trading partner to continue their efforts to meet the requirements until FDA has approved or denied the request.
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