GS1 just updated their website with the newly updated versions of their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) which were ratified by the GS1 Board on Monday. Both carry the new version number “1.1”. The two standards are separate but intertwined because the core business vocabulary is used within the various EPCIS events, so the two standards are likely to always be updated at the same time, as in this case.
This update marks the culmination of several years worth of hard work by the team, co-chaired by Michele Southall of GS1 US and Andrew Kennedy of FoodLogiQ, facilitated by the great Gena Morgan of GS1 US and with Ken Traub serving as the Editor for both standards documents, under the GS1 Global Standards Management Process (GSMP).
WHY THIS IS SIGNIFICANT FOR THE PHARMA SUPPLY CHAIN
This is a significant event for pharma supply chains around the world, but particularly for the one in the United States. That’s because the new version of these standards provide lot-based event capabilities for the first time. Without that capability, EPCIS might not be very usable for meeting the Drug Supply Chain Security Act (DSCSA) since that law requires lot tracking through November 2023. Solution providers can now make use of the new lot-based features of EPCIS 1.1 and CBV 1.1 to implement solutions for meeting the DSCSA TI, TH and TS transaction data exchange requirements interoperably. That is, in a way that all competing commercial implementations can understand, as long as they all use version 1.1.
The new versions also include a new event type, known as “TransformationEvent”, that can be used by drug repackagers to document their repackaging operation in standard EPCIS events. This is critical for a small subset of drugs passing through the U.S. supply chain.
The publication of these new versions will trigger the publication of updated guidance from GS1 Healthcare US on how companies might meet the DSCSA using these updated standards. We should see that publication in a matter of days, now that the updated GS1 standards have been made public. Once that happens, I will have more to say about the combination of these updates.