As anticipated, the US Food and Drug Administration (FDA) has announced that they will not be extending the stabilization period for enhanced drug distribution security requirements of section 582 of the FD&C Act for trading partners. The FDA is however granting exemptions to corporate entities defined as “small dispensers” if they have a total of 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians from November 27, 2024, to November 27, 2026, but is urging those small dispensers to continue their efforts to implement necessary measures to satisfy the enhanced drug distribution security requirements. This means that unless exempted as a “small dispenser” companies have until November 27, 2024, to ensure they have a mature system in place—ready to process and fully implement the Drug Supply Chain Security Act (DSCSA) enhanced drug distribution security requirements.

The FDA made a similar announcement earlier in May stating that there would be no further delays in enforcing the requirements for manufacturers’ track and trace verification systems under the DSCSA. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), affirmed at the 2024 FDLI Annual Conference that these systems are expected to be operational by November.

Systech understands that compliance with the DSCSA may be a daunting task. As the global leader in pharmaceutical serialization and product tracing with decades of experience, we have the expertise to help navigate companies through the DSCSA compliance process. Our UniTrace® platform enables you to connect with your trading partners, securely exchange transactional information and statements, and leverage the partnerships we have established for product verification and investigations.

Now is the time to choose a trusted industry partner with Systech. Don’t delay, contact a DSCSA compliance expert today!