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GS1 US published new guidelines in preparation for the serialization and traceability requirements associated with DSCSA.
GS1 US published a new release of the guideline Applying GS1 Standards for DSCSA and Traceability (R1.2) on Nov. 9, 2016 to assist the pharmaceutical industry in preparing for the Drug Supply Chain Security Act (DSCSA). The new release builds upon version 1.1 of the guideline and takes advantage of new features in the GS1 Electronic Product Code Information Service (EPCIS) and Core Business Vocabulary (CBV), GS1 standards that enable trading partners to share information about the physical movement and status of products as they travel throughout the supply chain.
EPCIS enables supply chain partners to capture and exchange information about supply chain events (e.g., packing, shipping, receiving, dispensing) using a standard format. FDA 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 needed for the information handling and retrieval provisions of the DSCSA law.
“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, vice-president of healthcare, GS1 US in a 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.”
The guideline is being published in the new GS1 US DSCSA Implementation Suite, which also includes three reference documents containing additional guidance on business process applications. It was developed by the GS1 Healthcare US Secure Supply Chain Workgroup, where manufacturers, wholesalers, retail pharmacies, healthcare providers, government agencies, and industry associations worked together to examine how GS1 Standards can best be applied to support DSCSA and traceability. The new release of the guideline updates the EPCIS traceability event specifications based on the latest release of EPCIS and CBV standards, which were ratified in September 2016. Their work also produced updated and expanded supply chain choreographies and exception scenarios (including detailed diagrams, flowcharts, and XML examples) to show industry members how to apply and use the standards in business processes.