After the FDA’s November 27, 2023 deadline for the Drug Supply Chain Security Act, traceability will move from lot-level to package-level; data will need to accompany product every time it changes hands. With this change, there will be an explosion in EPCIS file exchanges, from 5,000 per day to 500,000 and beyond.
EPCIS data exchange is new to many trading partners, and errors are inevitable. Exceptions halt product movement, add complexity, and increase staff workloads, boosting labor and costs. As well, they can cause delays that keep medicines from being available to patients.
In anticipation of these problems, LSPediA is launching a pilot program to improve DSCSA exceptions management in the supply chain.
This pilot will provide agnostic exceptions solutions for the entire supply chain. Qualified participants are manufacturers, wholesale distributors, dispensers, and healthcare providers, including both LSPediA customers and non-customers.
The pilot covers a range of issues with EPCIS data, data exchanges, and logistics, incorporating HDA’s “Exceptions Guidelines for the DSCSA.” These include product without data, data without product, and other discrepancies.
The pilot will compile a comprehensive list of error scenarios, and design methods to resolve them. From there, it will develop metrics to evaluate each method, recommend best practices, and reach consensus on how they should be applied.
Pilot members will meet bi-weekly on Wednesdays at 2PM ET, starting on January 13, 2023. The program will conclude in May 2023.
This pilot is an opportunity to gain unique insights into some of the most difficult issues facing the pharmaceutical industry. As well, your team can learn and exchange ideas about exceptions management, DSCSA compliance, and pharmaceutical serialization, guided by top experts in the field. Qualified trading partners are welcome to join.
Sign up here to receive the pilot program documents.
And, as always, you can contact us online or write to dscsa@lspedia.com with any questions.
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