Pharma Prepares for DSCSA Item-Level Traceability Requirements

New release of GS1 US guideline helps pharmaceutical industry prepare for DSCSA item-level traceability requirements.

GS1 US has published a new release of the guideline, Applying GS1 Standards for DSCSA and Traceability (R1.2), 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 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 – from business to business and ultimately to consumers.

EPCIS enables supply chain partners to capture and exchange information about supply chain events (e.g., packing, shipping, receiving, dispensing, etc.) 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 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. “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 through the commitment and dedication of the GS1 Healthcare US Secure Supply Chain Workgroup, where leading 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.

Based on their work, 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.

GS1 US will continue working with industry to extend the guideline to support management of historical and transactional data, contract manufacturing, repackaging, exception processing, as well as lot- and item-level data management through the transition period. For more information and resources visit www.gs1us.org/dscsa.

GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to improve patient safety and supply chain efficiency. GS1 Healthcare US brings together members from all segments of the healthcare industry to address the supply chain issues that most impact healthcare in the United States. Facilitated by GS1 US, GS1 Healthcare US is one of more than 30 local GS1 Healthcare user groups around the world that support the adoption and implementation of global standards developed by GS1. www.gs1us.org/healthcare.

GS1 US, a member of GS1, is an information standards organization that brings industry communities together to solve supply chain problems through the adoption and implementation of GS1 Standards. More than 300,000 businesses in 25 industries rely on GS1 US for trading-partner collaboration and for maximizing the cost effectiveness, speed, visibility, security and sustainability of their business processes. They achieve these benefits through solutions based on GS1 global unique numbering and identification systems, barcodes, Electronic Product Code (EPC)-based Radio Frequency Identification (RFID), data synchronization, and electronic information exchange. GS1 US also manages the United Nations Standard Products and Services Code (UNSPSC). www.GS1US.org.