GDP in the US: FDA Launches DSCSA Assessment for Small Dispensers and Issues Exemptions

The U.S. Food and Drug Administration (FDA) has launched a Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers. The assessment is intended to evaluate the ability of small dispensers, defined as pharmacies with 25 or fewer full time employees, to conduct interoperable electronic tracing of products at the package level.

The FDA encourages small dispensers to complete the assessment survey by 22 September 2026. A separate entity, such as a consultant, solution provider or wholesale distributor, may complete the survey on behalf of a small dispenser.

In addition, the FDA is issuing exemptions from certain requirements under Section 582 of the Federal Food, Drug, and Cosmetic Act for small dispensers and, where applicable, their trading partners until 27 November 2027. This period will allow the FDA to complete the assessment, publish the final assessment report for public comment and hold a public meeting on the assessment.

For further information, please read the FDA publication.