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.
A Member-Owned Company Serving Independent Pharmacies
PBA Health is dedicated to helping independent pharmacies reach their full potential on the buy-side of their business. Founded and run by pharmacists, PBA Health serves independent pharmacies with group purchasing services, wholesaler contract negotiations, proprietary purchasing tools, and more.
An HDA member, PBA Health operates its own NABP-accredited warehouse with more than 6,000 SKUs, including brands, generics, narcotics CII-CV, cold-storage products, and over-the-counter (OTC) products — offering the lowest prices in the secondary market.
