Food and Drug Administration (FDA) has granted small dispensers (pharmacies) and, where applicable, their trading partners an exemption from certain requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) until November 27, 2026. With this exemption, small dispensers will have more time to stabilize their operations to completely implement the Drug Supply Chain Security Act’s (DSCSA’s) drug distribution security requirements.
FDA classifies a dispenser as a small dispenser if “the company that owns [it] has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.” FDA notes, “Trading partners that do not qualify for the small dispenser exemptions and are unable to meet the enhanced drug distribution security requirements of [S]ection 582 of the FD&C Act by November 27, 2024, may request a waiver or exemption from those requirements.” Additional details about requesting a waiver or exemption are available in the FDA press release; the agency states that the DSCSA one-year stabilization period will still end on November 27, 2024, and will not be extended beyond this date.