Last July, the FDA revised its 2014 guidance with new standards for the data exchange necessary for product tracing. In addition to phasing out paper transaction records, the guidance made the long-awaited recommendation that pharmaceutical trading partners adopt GS1's Electronic Product Code Information Services (EPCIS) standard, citing its ability to ensure DSCSA compliance, its compatibility “with a range of technological approaches,” and its broad acceptance by trading partners across the industry. Further, it emphasized that pharma businesses ought to “make a collaborative effort” to follow the shared standard.
The guidance bolstered the pharma supply chain's transition to electronic information sharing by backing a secure, accessible, efficient, and uniform method for partners to confirm that the products they're exchanging are safe and genuine. It made clear that trading partners who ignored EPCIS were incurring risks to themselves and their partners.
As LSPedia CEO Riya Cao said in her comments to our Customer Advisory Board, “There’s no looking back. The FDA has confirmed it, and the industry has conformed.”
EPCIS is a standard designed to capture and share supply chain events in a common, interoperable way, providing visibility into a product from its creation to final end-user sale. It enables trading partners to share detailed product data between organizations, supporting accurate track-and-trace operations. Its data consists of events, records of changes that affect a physical item's status.
EPCIS data details what happened, where and when it happened, and other changes, such as:
EPCIS files record any number of events in detail. Attempting to review a single file manually, depending on its history, can take minutes of scrolling; yet another reason to automate as much of the process as you can. But not only are EPCIS files large and complex, they're increasing massively in volume.
In January, LSPedia found that total EPCIS exchange volume in the Test Environment -- where manufacturers test their EPCIS exchange with wholesale customers -- had increased by fifteen times the previous month. After an extended period where volume held steady at around 1,000 per month, the volume skyrocketed in December. The increase shows that upstream trading partners are getting on track now.
Item-level traceability, which goes into enforcement on November 27, 2023, means that each individual saleable unit will have its own file. Our estimate is that, overall, this change will increase overall file exchanges one hundred-fold.
Trading partners who aren't ready for that volume of EPCIS file exchanges are going to be at risk of expensive slowdowns. (And, of course, those who don't comply with DSCSA at all will be at risk of heavy costs, regulatory consequences, and generally being unable to do business). Businesses that haven't begun their DSCSA compliance journey yet have a fairly short time left to align with this transformational change.
With such massive increases in data complexity and data exchange volume, the industry is bracing for a commensurate increase in the transaction data errors known as exceptions. Every business in the pharma supply chain will need to be ready for these, and they can be unpredictable, particularly as new situations occur across all businesses following the switch to EPCIS. Without preparation, any pharma trading partner is vulnerable to problems that can be difficult and time-consuming to solve -- all while product is quarantined.
LSPedia can make DSCSA compliance easy and stress-free for any pharma trading partner. We can make sending and receiving EPCIS easy, but we can't slow down time, and the deadline's getting closer. Here area few places to start: