Supply Chain Security

DSCSA EPCIS – GS1 Track and Trace

Drummond Group has developed an automated testing platform which will allow drug manufacturers, wholesalers, repackagers, and dispensers to troubleshoot and test their EPCIS event messaging implementation.

The Drug Supply Chain Security Act (DSCSA) lays out steps for the development of systems to track and trace prescription drugs as they are shipped throughout the country.  The DSCSA requires drug manufacturers, wholesalers, repackagers, and dispensers to develop interoperable systems for the exchange of commissioning, packaging, and shipping information.

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.

Where can I get more information?

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Drummond Group has developed an automated testing platform which will allow drug manufacturers, wholesalers, repackagers, and dispensers to troubleshoot and test their EPCIS event messaging implementation.  The Drummond Group 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.

Frequently Asked Questions

DSCSA and EPCIS Track and Trace

Who is Drummond Group?

Drummond Group is a global software test and certification lab that serves a wide range of vertical industries. In healthcare, Drummond Group tests and certifies Controlled Substance Ordering Systems (CSOS), Electronic Prescription of Controlled Substances (EPCS) software and processes, Electronic Health Records (EHRs), and EPCIS for DSCSA – designating the trusted test lab as the only third-party certifier of all four initiatives designed to move the industry toward a digital future. Founded in 1999, and accredited for the Office of the National Coordinator HIT Certification Program as an Authorized Certification Body (ACB) and an Authorized Test Lab (ATL), Drummond Group continues to build upon its deep experience and expertise to deliver reliable and cost-effective services. For more information, please visit https://www.drummondgroup.com.

What is the Drug Supply Chain Security Act (DSCSA)?

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. The DSCSA requires drug manufacturers, wholesalers, repackagers, and dispensers to develop interoperable systems for the exchange of commissioning, packaging, and shipping information. 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. Find out more at: https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/

What are the tracing requirements of the DSCSA?

Manufacturers, wholesale drug distributors, repackagers, 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.

What are the deadlines of the DSCSA?

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.

Who is GS1?

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

What is EPCIS?

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 Group 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

How Does EPCIS Meet the Requirements of the DSCSA?

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

What is conformance testing?

Drummond Group is committed to the GS1 EPCIS testing program and has developed an automated conformance testing tool for EPCIS messaging compliance. The Drummond Group testing platform allows drug manufacturers, wholesalers, repackagers, and dispensers to troubleshoot and test their EPCIS event messaging implementation.

What scenarios are tested in conformance testing?

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)

Why undergo conformance testing?

Conformance testing with the Drummond Group 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 Group test tool will allow a company to receive a GS1 DSCSA Trustmark.

What is a GS1 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.

What is the Drummond Group EPCIS DSCSA conformance tool?

The Drummond Group 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.

Where can I get more information?

Provide your information below and we will immediately send you our informative whitepaper.    
  

What other services does Drummond Group offer?

In healthcare, Drummond Group is the industry leader and DEA approver certification organization for Controlled Substance Ordering Systems (CSOS) and Electronic Prescription of Controlled Substances (EPCS) software, and an ONC Authorized Certification Body for Electronic Health Records (EHRs). Drummond Group also offers comprehensive security services including penetration testing, vulnerability assessments, and HITRUST, NIST, and SOC 2 auditing.

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