LAWRENCEVILLE, NJ – November 13, 2018 – GS1 US® has launched a new GS1 US Rx EPCIS Conformance Testing Program, designed to support the pharmaceutical industry in implementing the Electronic Product Code Information Services (EPCIS) standard to meet the data exchange requirements of the United States Drug Supply Chain Security Act (DSCSA). Conformance testing validates that an EPCIS event file follows the industry suggested format and structure for serialized item data exchange. Drummond Group is the first third-party conformance testing service provider to have been certified by GS1 US, and will administer EPCIS Rx Conformance tests.
To improve patient safety, DSCSA requires that by 2023 pharmaceutical trading partners share chain-of-ownership data in a manner that allows for serialized item traceability back to the product origin. Members of the U.S. pharmaceutical industry have been preparing their systems and business processes to meet DSCSA requirements and many have chosen to use EPCIS to support DSCSA data exchange. To aid their work, GS1 US established a program to evaluate EPCIS messages for their conformance to the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability, which was developed by industry and GS1 US and offers best practices for implementing EPCIS.
The GS1 EPCIS Standard enables supply chain partners to capture information about events such as commissioning, packing and shipping, and to share that information securely in near real-time. EPCIS events are discrete data files that record a pre-defined set of data about the movement and status of objects in the supply chain; they are generated by manufacturers, wholesalers/distributors, and solution providers. “Companies across the U.S. pharmaceutical industry are choosing to leverage EPCIS as they prepare their systems and business processes to meet 2023 DSCSA interoperability requirements,” said Siobhan O’Bara, senior vice president of industry engagement and services, GS1 US. “The goal of the conformance testing program is to support and streamline trading partner on-boarding with a mechanism that provides a level of confidence about readiness, implementation quality and consistency.”
More than 100 individuals in the U.S. pharmaceutical industry, representing nearly 50 organizations – including leading manufacturers, wholesalers, retail pharmacies, healthcare providers, government agencies and industry associations – have collaborated with members of the GS1 Healthcare US® Initiative to determine how the EPCIS Standard can best be applied to support DSCSA serialized item traceability. GS1 US continues to certify third-party testing services to administer the conformance tests. GS1 US will also continue to oversee the issuance of Trustmarks for EPCIS event generators and each role-based test scenario they pass.
Companies interested in becoming a GS1 US certified EPCIS conformance testing service should contact SPProgram@gs1us.org. For more information about how GS1 US supports DSCSA implementation, visit www.gs1us.org/DSCSA.
About GS1 Healthcare US
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®. For more information, visit www.gs1us.org/healthcare.
About GS1 US
GS1 US®, a member of GS1® global, is a not-for-profit information standards organization that facilitates industry collaboration to help improve supply chain visibility and efficiency through the use of GS1 Standards, the most widely-used supply chain standards system in the world. Nearly 300,000 businesses in 25 industries rely on GS1 US for trading partner collaboration that optimizes their supply chains, drives cost performance and revenue growth while also enabling regulatory compliance. They achieve these benefits through solutions based on GS1 global unique numbering and identification systems, barcodes, Electronic Product Code-based RFID, data synchronization, and electronic information exchange. GS1 US also manages the United Nations Standard Products and Services Code® (UNSPSC®). www.gs1us.org