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In new guidance from the U.S. Food and Drug Administration (FDA), the organization states it doesn’t intend to enforce the Enhanced Drug Distribution Security (EDDS) requirements of the U.S. Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2024.
However, the FDA strongly reiterated that the law has not changed and this guidance “should not be viewed as providing a justification for delaying efforts … to implement EDDS requirements.” So, what are the implications of the FDA’s guidance and what should pharmaceutical supply chain trading partners do next?
Watch this webinar to find out! Dan Walles, General Manager of Track and Trace/Compliance at TraceLink, provides insight into the FDA’s latest guidance, feedback from attendees at the recent HDA Traceability Seminar, and more. Topics include:
- What enforcement discretion means for manufacturers, wholesalers, and dispensers.
- How members of the industry, including manufacturers, wholesalers and dispensers, are responding to the announcement and what they expect from their trading partners.
- How to use the next year to stabilize systems and processes to meet the EDDS requirement before enforcement discretion ends.
- What the new timeline looks like for deploying and stabilizing systems.
- How TraceLink solutions offer the fastest and lowest-cost path to DSCSA compliance.
The clock is ticking and most pharmaceutical supply chain trading partners still have a lot of work to do. Watch the webinar today and get the answers you need to inform your pivotal next steps.
Featured Speaker
Dan Walles
General Manager
Track & Trace/Compliance
