FDA Issues U.S. Drug Supply Chain Update on Waivers and Exemptions for Small Dispensers
(June 21, 2024) – On June 12, the Food and Drug Administration
announced the FDA is issuing exemptions from certain requirements of section 582 of the FD&C Act to small dispensers (pharmacies) and, where applicable, to their trading partners until Nov. 27, 2026. The FDA stated this provides small dispensers additional time to stabilize their operations to fully implement the Drug Supply Chain Security Act enhanced drug distribution security requirements. A dispenser is considered a small dispenser for the purposes of these exemptions if, as of Nov. 27, 2024, the company that owns the dispenser has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians. Consult the
FDA announcement for more information on requesting a waiver or exemption.
--
Karen Braman