DSCSA EPCIS — GS1 Track and Trace FAQs
The Drug Supply Chain Security Act (DSCSA) was enacted by Congress in November of 2013 and lays out steps for the development of systems to track and trace prescription drugs as they are shipped throughout the country. Implementation of the DSCSA regulations help the U.S. Food and Drug Administration (FDA) and law enforcement detect drugs that may be stolen, contaminated, or counterfeit.
GS1, the global leader in standards for business communication, has developed the EPC Information Services (EPCIS) standard which allows for disparate applications to share and transfer data, and has adapted it to meet the DSCSA requirements. In order to demonstrate that a company has correctly implemented the GS1 EPCIS messaging standards for DSCSA they must undergo conformance testing.
Drummond has developed an automated testing platform which will allow drug manufacturers, wholesalers, re-packagers, and dispensers to troubleshoot and test their EPCIS event messaging implementation. The Drummond track and trace testing platform will allow for companies to upload messages and receive immediate feedback if they meet the GS1 requirements for EPCIS messaging for DSCSA conformance. Successful completion will allow companies to receive a Trustmark indicating their conformance to the DSCSA messaging requirements.