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 U.S. 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.