DSCSA EPCIS — GS1 Track and Trace FAQs

The first upcoming deadline is for product serialization. Starting November 2018, manufacturers must affix a product identifier to their packages, and only transact in products correctly labeled. This requirement applies to manufacturers starting November 2019, and distributers November 2020. The final deadline arrives in November of 2023 when the entire supply chain must have complete unit level traceability and interoperability.
GS1 is a not-for-profit organization that develops and maintains global standards for business communication. GS1 has developed the standard for barcodes and Global Trade Item Numbers (GTIN) as well as the Electronic Product Code Information Services (EPCIS) standard which has been adapted to meet the DSCSA requirements for track and trace. You can find more about GS1 standards at https://www.gs1.org/standards
Electronic Product Code Information Services (EPCIS) is a global GS1 Standard for creating and sharing event data regarding the physical movement and status of products throughout the supply chain. EPCIS tracks individual supply chain business processes such as commissioning, packing, and shipping, and provides a standard format through which entities in the supply chain can communicate the business information about each step to trading partners. The current version of EPCIS is 1.2; however, Drummond offers testing for version 1.1 as well. You can get more information as well as the current standards at https://www.gs1.org/standards/epcis
GS1 has published their Implementation Guideline for Applying GS1 Standards for DSCSA R1.2 which details how to use the EPCIS standard to meet the DSCSA traceability requirements. The components of EPCIS align with the DSCSA requirements in the following ways.
  • Transaction information (TI) — EPCIS Events
  • Transaction history (TH) — EPCIS Event History
  • Transaction statement (TS) — EPCIS Document Header
Drummond is committed to the GS1 EPCIS testing program and has developed an automated conformance testing tool for EPCIS messaging compliance. The Drummond testing platform allows drug manufacturers, wholesalers, re-packagers, and dispensers to troubleshoot and test their EPCIS event messaging implementation.
Conformance testing consists of seven test scenarios for manufacturers and nine for wholesalers. Test variables cover scenarios for:
  • Single purchase orders
  • Multiple purchase orders
  • Purchase orders with and without aggregation
  • Shipments 24 hours after transaction
  • Direct purchases (manufacturers)
  • Drop shipments (wholesalers)
Conformance testing with the Drummond conformance tool allows supply chain entities generating EPCIS messages to validate those messages and ensure compliance with the DSCSA tracing requirements. Successful completion of a test scenario in the Drummond test tool will allow a company to receive a GS1 DSCSA Trustmark.
A Trustmark is a seal issued by GS1 that indicates successful completion of one or more of the GS1 test scenarios for EPCIS 1.2. A Trustmark is awarded for the set of test cases successfully completed. In order to be eligible a company must pass validation by the Drummond tool for at least one GS1 test scenario.
The Drummond tool is a web portal that allows entities in the drug supply chain and software vendors to assess their EPCIS messages for compliance with the DSCSA rule. The tool will analyze uploaded EPCIS documents and provide detailed feedback on their conformance with the GS1 Implementation Guideline for DSCSA.

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