The Food and Drug Administration is exempting small pharmacies and other small dispensers from certain DSCSA interoperable system requirements until Nov. 27, 2025, to prevent disruptions of patient access to their medications. This follows NCPA’s continued and consistent advocacy efforts on this issue, spanning more than 10 years.
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. Trading partners who utilize these exemptions do not need to notify the FDA.
Additionally, the FDA is still allowing pharmacies and other small dispensers (a corporate entity that owns the dispenser and has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians) to be exempt from certain DSCSA interoperable system requirements until Nov. 27, 2026.
Pharmacies who have not completed or made documented efforts to connect to wholesalers can learn more about compliance from https://ncpa.org/dscsa-360. Trading partners that don’t qualify for the exemptions above and are unable to meet the interoperability requirements granted in the exemptions by Nov. 27, 2024, may request a waiver, exception, or exemption from those requirements.
