"> DSCSA EPCIS — GS1 Track and Trace FAQs – Drummond Group

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.

  • Manufacturers, wholesale drug distributors, re-packagers, and dispensers in the drug supply chain must provide information about a drug and who handled it each time it is sold in the U.S. market. The DSCSA requires that the following be captured for each transaction. Transaction Information (TI): This consists of details about the drug and the specific transaction. The TI includes NDC code, lot and serial numbers, date, and business name and addresses. Transaction History (TH): The transaction history is the transaction information for each prior transaction through the supply chain. Each time a product changes hands — from manufacturer to wholesaler to dispenser — must be recorded in the transaction history. Transaction Statement (TS): The transaction statement is a statement that each party is authorized to ship or receive drugs as required by the DSCSA and did not knowingly ship or receive suspect or illegitimate product.

  • 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.

  • Get started by emailing dscsa_epcis@drummondgroup.com

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