The Food and Drug Administration (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 is intended to support continued implementation of DSCSA without disrupting patient access to their medications.
Small dispensers—November 27, 2026
The 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. A dispenser is considered a small dispenser, for the purpose 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.
Large dispensers—November 27, 2025
The FDA is issuing exemptions from certain requirements of section 582 of the FD&C Act to large dispensers—those with 26 or more full-time employees—until November 27, 2025. Trading partners who utilize these exemptions do not need to notify the FDA.
If you have any questions, please email customercare@pbahealth.com or call us at 800.333.8097.
