GS1 updates guidance for US drug traceability

Phil Taylor, 16-Nov-2016

With just 12 months to go until medicine packs in the US need to be serialized, standards body GS1 has published a new guide to help companies prepare.

The new version of the Applying GS1 Standards for DSCSA and Traceability document builds on the previous release by incorporating GS1's updated Electronic Product Code Information Service (EPCIS) and Core Business Vocabulary (CBV) standards that "enable trading partners to share information about the physical movement and status of products as they travel throughout the supply chain."

By November 27, 2017, drug manufacturers will have to mark packages with a product identifier, serial number, lot number and expiration date, using a 2D datamatrix barcode, and lot-level transaction information must be available electronically.

Serialization deadlines for repackagers, wholesalers, and dispensers follow in 2018, 2019 and 2020, although a full unit-level requirement to electronically track packs through the supply chain is not due to come into effect until 2023.

Adding the new EPCIS features to the guide is key to helping the supply chain partners prepare for these deadlines, says GS1. EPCIS can be used to capture and exchange information about supply chain events - packing, shipping, receiving, and dispensing, for example - using a standard format.

While the FDA hasn't issued any mandate on the transaction standards that need to be used, it has indicated that EPCIS complies with the DSCSA data exchange requirements. The new release of the guideline updates the EPCIS traceability event specifications based on the latest release of EPCIS and CBV standards, which were ratified in September 2016.

"As industry completes its preparations to go live with DSCSA serialization requirements for 2017, pharmaceutical companies are increasingly focusing on the journey to DSCSA item-level traceability, which must be in place by 2023," said Greg Bylo, vice president of healthcare, GS1 US.

"The new release of the guideline provides the tools they need to plan, pilot and implement an EPCIS-based approach to address those requirements and supports the main goals of DSCSA -increased transparency and security in the pharmaceutical supply chain," he added.