FDA has extended certain Drug Supply Chain Security Act (DSCSA) exemptions for small dispensers for an additional year, moving the deadline from Nov. 27, 2026, to Nov. 27, 2027.
For purposes of the exemption, FDA considers a pharmacy a small business dispenser if the corporate entity that owns it has 25 or fewer full-time employees who are licensed pharmacists or qualified pharmacy technicians as of Nov. 27, 2026. Qualifying pharmacies do not need to apply for the exemption or notify FDA that they intend to use it.
The DSCSA small dispenser exemption provides additional time before qualifying pharmacies must fully implement certain enhanced electronic, interoperable package-level tracing requirements. FDA emphasized, however, that pharmacies should continue working toward full compliance during the extension period.
The extension also gives FDA time to complete its Assessment of Small Dispensers, which will examine the availability, cost and practicality of the technology needed for small pharmacies to comply with electronic package-level tracing requirements.
FDA is encouraging small dispensers to participate in the assessment by completing a survey by Sept. 22, 2026.