The FDA is extending exemptions from certain drug supply chain security requirements for small dispensers, such as pharmacies, and their trading partners, where applicable, until Nov. 27, 2027.
The exemptions apply to certain requirements under Section 582 of the Federal Food, Drug, and Cosmetic Act. A dispenser qualifies as a small dispenser for purposes of the exemptions if, as of Nov. 27, 2026, the company that owns it has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians, according to an Aug. 6 FDA news release.
The exemptions provide time to complete the small dispenser assessment, publish the final assessment report for public comment and host a public meeting on the assessment. The FDA encourages small dispensers to complete the assessment survey by Sept. 22, 2026.
Small dispensers and their trading partners using the exemptions do not need to submit anything to the FDA or inform the agency. The FDA urged small dispensers to continue efforts to implement measures needed to comply with enhanced drug distribution security requirements.
Trading partners that do not qualify for the exemptions and cannot meet the requirements may request a waiver, exception or exemption. The FDA expects them to continue compliance efforts until the agency approves or denies the request.
