The US Food and Drug Administration (FDA) has recently made it clear that there will be no further delays in enforcing the requirements for manufacturers’ track and trace verification systems under the Drug Supply Chain Security Act (DSCSA). Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), affirmed at the 2024 FDLI Annual Conference last week that these systems are expected to be operational by November.

Cavazzoni also confirmed the readiness of the FDA’s NextGen portal to receive DSCSA-related documents and that fully in-person meetings for the FDA committee will resume by September. Additionally, she discussed an upward trend in new drug applications that integrate artificial intelligence and machine learning technologies.

Since the DSCSA was enacted over a decade ago, the FDA has granted several delays of enforcement for compliance. However, the latest “stabilization period” ends in November 2024, and this time, we can rest assured there will be no further delays. If your company has not yet implemented an electronic, interoperable system for transmitting transaction information and statements as required by the DSCSA, now is the time to act. Systech is here to support your efforts with our UniTrace™ platform.

As the global leader in pharma serialization and product tracing, Systech provides the solutions and expertise needed to navigate the DSCSA compliance process. Our centralized, cloud-based solution enables the consolidation, sharing, management and reporting of product data from multiple sources. This helps to ensure transfer visibility and secure data exchange to achieve DSCSA compliance. Our solution includes trading partner connectivity, product tracking, recalls and returns, suspect product investigations, warranty management, materials provenance and more. Additionally, it delivers new insights and fosters digital trust.

It’s time to run the final stretch and ensure your readiness and resilience. Don’t delay, contact a DSCSA compliance expert today!