The Food and Drug Administration (FDA) just issued an exemption extension to the November 2026 deadline for interoperability requirements for small dispensers under the Drug Supply Chain Security Act (DSCSA). Qualified small dispensers will now have an additional year to continue working toward interoperability requirements. By November 27, 2027, small dispensers will be required to

  • electronically exchange transaction information and transaction statements
  • electronically verify suspect or illegitimate products
  • electronically respond to trading partner verification requests
  • provide package-level tracing

Small dispensers are considered pharmacies under the same corporate entity with 25 or fewer full-time pharmacists or technicians. Pharmacies do not need to notify the FDA if they plan to utilize the extension. Pharmacies that are considered large dispensers because they employ 26 or more full-time employees across the same corporate entity should already be in compliance with the interoperability requirement as of November 2025, so this extension does not apply to them.

The FDA has also asked all small dispensers to voluntarily complete an assessment survey by September 22, 2026. A consultant may complete the survey on the pharmacy’s behalf. The survey results will help the FDA evaluate the availability, cost, and operational feasibility of the technology needed for electronic package-level tracing.

The survey contains up to 41 questions related to pharmacy resources that have been or will be devoted to DSCSA readiness, potential costs incurred, and electronic data transaction challenges the pharmacy has experienced thus far. Some of the questions may require time to research and complete, so pharmacies who plan to respond should plan accordingly.  While not required, these insights may be helpful to the FDA in understanding small dispenser challenges.

This extended deadline will not affect how Morris & Dickson provides EPCIS data to customers. Trading partners will continue to make electronic data available as part of the distributor requirements for manufacturers, large dispensers, and for small dispensers that are already in compliance with interoperability requirements.

 Pharmacies should already be complying with many of the existing requirements today. These include:

  • ensuring the pharmacy is purchasing only from authorized trading partners
  • maintaining and retrieving transaction documentation in paper or electronic format
  • investigating suspect or illegitimate products
  • quarantining and reporting illegitimate products
  • maintaining standard operating procedures outlining how the pharmacy will fulfill these obligations

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While the latest FDA announcement does not eliminate DSCSA requirements for small dispensers, it does provide some additional time to continue working toward being able to receive electronic exchange of package-level tracing information.

As always, our Morris & Dickson account team is available to support our pharmacy customers with DSCSA compliance readiness. For additional questions, contact your Morris & Dickson account representative or email us at serialization@morrisdickson.com.