FDA Delays Parts of DSCSA Until 2026

Featured article provided by InfiniTrak

What do dispensers need to know about the FDA letter regarding exemptions for small businesses?

As pharmacies have been preparing for the final deadline for DSCSA Interoperability, the FDA has once again thrown another curveball. DSCSA regulations are already confusing, and this new exemption only adds to that confusion.

The FDA has issued a Small Business Exemption for small dispensers. They define a small dispenser as having fewer than 25 full-time pharmacists and pharmacy technicians. Small dispensers meeting these criteria now have until November 27, 2026, to be compliant with the Enhanced Drug Distribution Security requirements. This means that small dispensers will have extra time to be compliant with serialization, product verification and product tracing.

It is important to note all the other DSCSA regulations will still be in place and enforced on November 27, 2024. In fact, this Small Business Exemption for DSCSA makes it easier for the Boards of Pharmacy and FDA to strongly enforce the remaining requirements of the law which include:

  • Collecting and saving all transactional (T3) data for at least six years
  • Reconciling all drugs with your T3 data
  • Verifying trading partners are licensed
  • Documentation of standard operating procedures for DSCSA
  • Identifying and investigating any suspect product
  • Reporting illegitimate product to the FDA with Form 3911
  • Obtaining GLNs for every physical location
  • Confirming product identifiers are on the smallest salable unit for every product

Small dispensers who qualify for the exemption, will have to meet the above requirements, but may not have to:

  • Collect and receive serialized data (EPCIS)
  • Conduct a product verification on suspect product (VRS)
  • Conduct product tracing on a suspect product

Overall, most of the law is still on track for the November 27, 2024, deadline. Pharmacies need to be prepared for this new complex law which will impact how the pharmacy conducts business. The difference is small dispensers have been given a little more time for the interoperable aspects of the law.

InfiniTrak provides complete DSCSA compliance, including the interoperable phase of the law. All dispensers, large and small, can achieve compliance now with the Infinitrak platform. InfiniTrak’s association with many of the industry partners offers affordable discounted pricing.

Most pharmacies are continuing to move forward towards full compliance now rather than later. As a result, the pharmacies are delivering a higher level of patient safety and benefiting from the added value provided by the InfiniTrak platform.

Categorized as Updates