TraceLink Inc., a digital network platform company enabling product orchestration by connecting healthcare and life sciences entities through its B2N Integrate-Once network, is continuing its support of the Drug Supply Chain Security Act (DSCSA) 2023 via its partnership with GS1, a global, non-profit organization dedicated to global standards for efficient business communication, in the authoring the GS1 US Addendum Guidance and XML Examples for GS1 US DSCSA Implementation Guideline R1.3.

An early adopter of GS1 standards, TraceLink has exchanged over one million DSCSA-compliance EPCIS transactions between trading partners on the TraceLink network, with over 1,075 companies now being EPCIS-enabled for DSCSA compliance data exchange in preparation for November 2023 deadlines.

The latest implementation documents, published by GS1 US on May 26th, 2023, serve as an EPCIS serialized data exchange implementation blueprint for companies across the U.S. pharmaceutical and healthcare supply chain. The expanded documentation provides detailed descriptions of end-to-end trading partner event choreographies for serialized item traceability use cases under DSCSA.

As part of the collaborative effort, the GS1 Rx Secure Supply Chain Workgroup identified and documented 21 supply chain scenarios that encompass the majority of business use cases within the industry. Among these scenarios, 11 have been meticulously detailed with comprehensive business event choreographies and XML examples of electronic data exchange, including critical use cases for dropship, co-licensing, repackaging, and 340B programs. Leveraging its industry experience, including its leadership in the recent FDA pilot program on product tracing, TraceLink played a key role in spearheading the creation of 50 XML examples that effectively illustrate each of the 11 end-to-end trading partner message exchange choreographies for shipping and receiving products.

“Given the sense of urgency for November 2023, we want to jumpstart EPCIS implementations and demystify the technical “wirings” for orchestrating DSCSA exchanges for the industry’s most common supply chain choreographies,” said Elizabeth Waldorf, director, global traceability, and standards for TraceLink and member of the GS1 Healthcare US Executive Leadership Committee.