Last week, many pharmacy and healthcare industry organizations sent announcements that FDA granted a two-year exemption to small dispenses for complying with the Drug Supply Chain Security Act (“DSCSA”). However, many pharmacies still have questions whether the exemption applies to them and how it affects them.

To remind, the DSCSA was enacted in 2013 with the goal of creating an interoperable electronic system to trace certain prescription drugs as they are distributed in the United States.

The DSCSA’s requires:

  • Product identification (such as a bar code)
  • Product tracing (trading partners, such as manufacturers, wholesalers, and pharmacies must trace the product from creation until dispensing)
  • Product verification (trading partners must establish a system and processes to be able to verify products)
  • Product investigation (trading partners must quarantine and promptly investigate a drug that has been identified as suspect (i.e. counterfeit, unapproved, or potentially dangerous))
  • Notification (trading partners must notify FDA if they suspect that the product is illegitimate).

DSCSA has six compliance deadlines. The last one was to commence on November 27, 2023 and pertained to enhanced product tracing. Starting with November 27, 2023, wholesalers were to provide 2Ts (transactional information and transactional statement) in an electronic format (EPCIS) with serial number of the product. Before that date, drug products had to list 3Ts (transactional information, transactional statement, and transaction history) from their wholesalers.

Prior to the implementation deadline, many stakeholders sent comments to FDA explaining that many pharmacies had no technical capabilities to access EPCIS. As a result, FDA postponed the implementation to November 27, 2024.

On June 12, 2024, FDA granted yet another extension but only for small dispensers. This time the extension is for two years until November 27, 2026.  FDA defined “small dispensers” as pharmacies with 25 or fewer full-time licensed employees (such as pharmacists or technicians).  Most independent pharmacies fit within this definition.If they don’t, they can request an extension by sending a waiver request to FDA no later than August 1, 2024 (as recommended by FDA).

If you are a small pharmacy with less than 25 full-time licensed employees, you can continue with your current practices of not including package-level product identifiers until November 27, 2026.