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GS1 US RELEASES NEW GUIDELINES FOR ITEM-LEVEL PHARMACEUTICAL TRACEABILITY
- Nov 16, 2016 -

GS1 US RELEASES NEW GUIDELINES FOR ITEM-LEVEL PHARMACEUTICAL TRACEABILITY

GS1 US has introduced a new release of its "Applying GS1 Standards for DSCSA and Traceability" guideline, designed to help the pharmaceutical industry prepare for Drug Supply Chain Security Act (DSCSA) serialization and item-level traceability requirements in 2017 and 2023, respectively. The new release, version 1.2, builds upon version 1.1 of the guideline and takes advantage of new features in GS1's Electronic Product Code Information Service (EPCIS) and Core Business Vocabulary (CBV) standards, to help trading partners share information regarding the physical movements and status of products as they travel throughout the supply chain, from business to business and ultimately to consumers.

EPCIS enables supply chain partners to capture and exchange information about supply chain events (for example, packing, shipping, receiving and dispensing) using a standard format. The U.S. Food and Drug Administration selected EPCIS as a method that can be used to comply with DSCSA data-exchange requirements. As a GS1 data-sharing standard, EPCIS provides the data attributes and message structure required for the information handling and retrieval provisions of the DSCSA law, the standards group reports.

"As industry completes its preparations to go live with DSCSA serialization requirements for 2017, pharmaceutical companies are increasingly focusing on the journey to DSCSA item-level traceability, which must be in place by 2023," said Greg Bylo, GS1 US's VP of health care, in a prepared statement. "The new release of the guideline provides the tools they need to plan, pilot and implement an EPCIS-based approach to address those requirements and supports the main goals of DSCSA—increased transparency and security in the pharmaceutical supply chain."

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