Welcome to our October 2023 compliance update! It's a quick view of the most relevant news around DSCSA compliance, with tips for success and details on LSPedia's involvement across the industry.
Polish and test your systems. The FDA has published its DSCSA Stabilization policy, strongly emphasizing that the deadline under 582(g)(1) is still November 27, 2023 — and that the 12-month period should not be used as an excuse to delay your implementation. Rather, it's essential to use this time to polish and test your systems.
Read the FDA's EDDS guidance. As well, the FDA published EDDS guidance that includes detailed information on handling aggregation and data discrepancies. The guidance highlights the critical relationship between the physical product and the electronic data to be used to verify receipt of inventory and verification of product authenticity.
HDA Traceability Seminar. At the latest HDA Traceability Seminar, LSPedia CEO Riya Cao shed light on the topic, echoing the FDA's own statements that trading partners are at risk of regulatory penalties if they mistake the news to mean that they can delay DSCSA progress - and that even those who are implementing still have much to learn!
DSCSA Deadline Webinar Series. Not long afterward, we kicked off our DSCSA Deadline Webinar series! Tish Pahl explained current and future DSCSA requirements, and an expert panel delved into what trading partners across the industry need to do ahead of (and after) November 27, 2023. The #1 takeaway? "Don’t stop, don’t delay, we’ve got to keep moving."
DSCSA is a daily grind. If you're short on resources, you can benefit from PRG’s staff augmentation offering. Get expert help for trading partner connections, EPCIS onboarding, exceptions process, and more. Get in touch with PRG to learn more.
"Stopping or slowing efforts to get into compliance with 582(g)(1) puts a trading partner at risk of FDA enforcement." Read More