On August 6, 2026, Food and Drug Administration (FDA) announced it will grant exemptions from certain Drug Supply Chain Security Act (DSCSA) requirements under section 582 of the Food, Drug and Cosmetic Act (FD&C Act) to small dispensers such as pharmacies and their applicable trading partners. For purposes of the exemption, a dispenser is considered a “small dispenser” if the corporate entity that owns the dispenser has a total of 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians. This exemption will stay in effect until November 27, 2027.
This exemption allows time for FDA to complete the DSCSA Small Dispensers Assessment, publish the final assessment report for public comment, and host a public meeting on the assessment. FDA is encouraging small dispensers to complete the survey by September 22, 2026.
However, only some DSCSA requirements are part of this exemption. This extended year-long exemption period is a great opportunity for small dispensers to complete all DSCSA requirements and stabilize their workflows before the November 2027 deadline.
Key Dates:
- September 22, 2026 — Deadline for small dispensers to complete the small dispensers assessment survey.
- November 27, 2026 — Cutoff date for determining eligibility as a “small dispenser.”
- November 27, 2027 — Exemption expiration date; small dispensers must comply with enhanced drug distribution security requirements by this deadline.
What requirements are part of the exemption?
All of the exemptions are outlined in the FDA letter. Small dispensers can rely on manual or existing methods for the following:
- Exchanging transaction information and transaction statements with trading partners.
- Conducting product verifications for suspect and illegitimate products.
- Gathering transaction information for recalls at the package level.
- Gathering information to respond to a regulator in circumstances when they identify a suspect or illegitimate product.
What is required of small dispensers now?
Many aspects of DSCSA are already in effect and required today. For example, small dispensers must still:
- Know your prescription drug suppliers (sources). They must be an authorized trading partner as defined in Section 581 of the FD&C Act.
- Know where your current product tracing information (data) is being stored and how to access it.
- Know how to identify suspect products and have processes in place to quarantine, investigate, and communicate as required.
- Develop, update, and adhere to robust prescription drug purchasing policies and procedures (P&Ps) that accurately reflect your business location’s processes.
What exemption requirements should small dispensers implement now vs. later?
FDA and the National Association of Boards of Pharmacy (NABP) strongly encourage small dispensers to continue their efforts to implement the necessary measures to comply with DSCSA requirements. Efforts to fully comply with section 582 of the FD&C Act should not be delayed. Instead, the exemption period should be an opportunity to complete outstanding requirements and stabilize before November 2027.
As the purpose of this exemption period is for pharmacies to complete the small dispenser assessment and FDA to create and disseminate a report for public comment, small dispensers are encouraged to utilize the survey to share their perspectives and voice their concerns. The survey will be best informed by small dispensers who are trying to fully comply with data requirements.
Our digital tool, Pulse by NABP™, can help your business simplify DSCSA compliance. Dispensers are currently being onboarded. Create your free account and claim your facility profiles at dashboard.pulse.pharmacy to get started today.