FDA Grants Exemptions to Small Pharmacies from Drug Distribution Security Requirements

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.”

These exemptions are meant to provide small dispensers with “additional time to stabilize their operations to fully implement the enhanced drug distribution security requirements of the Drug Supply Chain Security Act (DSCSA).” Dispensers are considered “small dispensers” if the company that owns the dispenser has 25 or fewer full-time employees “licensed as pharmacists or qualified as pharmacy technicians.”

The stabilization period for all trading partners will end on November 27, 2024, but those that do not qualify for the small dispenser exceptions can still request a waiver or exemption. The request should contain “a detailed statement describing the reason(s) justifying the request,” “pertinent and applicable supporting documentation,” and “any special circumstances of a product and/or transaction.”