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New GS1 US Implementation Guideline Helps Pharmaceutical Industry Capture and Share Chain of Custody Data

Standards Support Serialization and Interoperability Requirements for DSCSA

Ewing, NJ – April 13, 2021 – GS1 US® has published a new guideline to assist the U.S. pharmaceutical industry in implementing the GS1 System of Standards to support chain of custody tracking, product serialization and item-level traceability for medications.

The document, “Applying GS1 System of Standards to Pharmaceutical Chain of Custody,” provides direction for communicating chain of custody events between supply chain partners using Electronic Product Code Information Services (EPCIS).

EPCIS is a GS1 Standard that allows companies to capture information about supply chain events (e.g., shipping, receiving, etc.) and to securely share that information with trading partners in near real time. EPCIS chain of custody event information can be used to help fulfill the traceability requirements of the U.S. Food and Drug Administration’s (FDA’s) Drug Supply Chain Security Act (DSCSA). As product moves across the supply chain, custody of that product changes from one trading partner to another. Event data exchanges with EPCIS help ensure that critical data fields are populated and transmitted, facilitating accurate, timely exchange of information that enables traceability.

The DSCSA requires pharmaceutical products to be serialized and labeled with standard product identifiers (Global Trade Item Numbers, or GTINs) on 2-dimensional (2D) barcodes (e.g., DataMatrix). Interoperable data exchange to support chain of custody tracking is encouraged for the contract manufacturers, contract packagers, third-party logistics providers and reverse logistics providers as suppliers to the U.S. pharmaceutical industry – all stakeholders for whom this guideline was developed.

The new implementation guideline was developed by GS1 US and the Rx Secure Supply Chain Workgroup, comprising manufacturers, wholesalers, retail pharmacies, healthcare providers, government agencies, industry associations and third-party logistics providers. The group worked together to analyze business processes and requirements, consider various options and map how GS1 Standards could best be applied for pharmaceutical chain-of-custody reporting across the industry. The document details all of the decision points, defining each event and data element needed to support track and trace, and outlines for industry members how to apply the standards to their own business processes.

“Serialization improves track and trace of products, wherever they are in the supply chain, and interoperable data exchange supports DSCSA requirements for traceability to improve patient safety,” said Angela Fernandez, vice president community engagement, GS1 US. “EPCIS event data provides crucial chain of custody information that can be shared and understood throughout the supply chain. The result is improved visibility that helps trading partners ensure timely distribution of the right medicine to the right patients at the right time and in the right location – the gold standard of patient care.”

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About GS1 US:
GS1 US®, a member of GS1 global, is a not-for-profit information standards organization that facilitates industry collaboration to help improve supply chain visibility and efficiency through the use of GS1 Standards, the most widely used supply chain standards system in the world. Nearly 300,000 businesses in 25 industries rely on GS1 US for trading partner collaboration that optimizes their supply chains, drives cost performance and revenue growth, while also enabling regulatory compliance. They achieve these benefits through solutions based on GS1 global unique numbering and identification systems, barcodes, Electronic Product Code (EPC®)-based RFID, data synchronization and electronic information exchange. GS1 US also manages the United Nations Standard Products and Services Code® (UNSPSC®). For more information, please visit