The Food and Drug Administration (FDA), in an announcement yesterday, October 9, 2024, is granting exemptions from specific requirements under the Drug Supply Chain Security Act (DSCSA). These exemptions apply to certain trading partners in the pharmaceutical supply chain. In August 2023, the FDA published policies to give companies more time to comply with the DSCSA’s security requirements for drug distribution. The rules include ensuring drug product traceability through electronic systems, as well as processes for verifying the authenticity of returned or suspect products. Below, we unpack what you should know about the DSCSA 2024 deadline extension.

What’s Happening Now 

Many companies have made significant progress in meeting these requirements by setting up systems for secure data exchange. However, some still face challenges in ensuring their systems are fully ready by the stabilization deadline of November 27, 2024. Specifically, they may be dealing with issues like missing or incorrect data, which could slow down the distribution of important medicines. 

In June 2024, the Partnership for DSCSA Governance (PDG) held a conference that was well attended by industry representatives and the FDA. The FDA shared at that time that there would be no further broad extension for the DSCSA required “interoperability” requirements. Individual exemptions could be obtained via the Wavers, Exceptions, and Exemption (WEE) process. Thus, if there was non-compliance, companies needed to apply. 

However, effective 10/09/2024, the FDA has again provided a broad-based enforcement waiver granted by trading partner type.  Clearly, the industry is still struggling with getting to full DSCSA interoperability compliance. 

What This Means 

The FDA recognizes that more time may be needed for companies that have already begun implementing these systems. They are offering exemptions to help avoid major disruptions in the supply chain, particularly for drugs that are in short supply. The FDA is extending the timeline for companies to fully meet drug tracing and verification requirements to ensure that drug distribution isn’t delayed due to technical issues with their data exchange systems. 

Key dates for this exemption include:  

• Manufacturers and repackagers: May 27, 2025 
• Wholesale distributors: August 27, 2025 
• Larger dispensers (26+ employees): November 27, 2025 

Trading partners who have initiated their systems and processes yet require these exemptions, due to challenges to full compliance to the DSCSA, do not need to notify the FDA.    

For trading partners who are not eligible for these exemptions but need additional time to meet the enhanced drug distribution security requirements by November 27, 2024, may request a waiver or exception. The FDA does expect trading partners to continue efforts to meet the requirements until further response.   

The FDA will update companies on further exemptions and guidance through official channels and its website. 

Need help?   

If you have any questions on the DSCSA 2024 deadline extension or DSCSA serialization requirements, Clarkston Consulting has experience with both the regulations and how to implement them. Our services extend from strategy, assessment, audit, and vendor selection through implementation. Connect with one of our serialization experts today.