EPCIS is on the rise in 2023

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.”

A Quick Guide to EPCIS

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:

• Item identification: A unique identifier assigned to each product unit (serial number, GTIN, EPC)

• Event data: Information about the transaction, movement, or status of the product, such as transaction history, transaction information, and transaction statement. (Note: Transaction History is being phased out with the final serialization deadline of November 27, 2023.)

• Location and time data: Information about the location of the product, such as facility, warehouse, or retail, and when it was received, shipped, or transferred between sites.

• Business data: Information about the transaction associated with the product, including the parties involved, quantity of product, and terms of the transaction.

• Aggregation: Details on how the product has been aggregated to a case or pallet.

The EPCIS Explosion

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.

Getting On Board with EPCIS

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:

• LSPedia's industry-leading Investigator technology is built with hundreds of GS1 data rules, serialization algorithms, and integration APIs to automatically find problems, alert users to them, and guide the resolution process. Investigator is at the heart of the Exceptions Pilot, and it'll only get better over time.

• ‍‍If you're concerned about exceptions (and you should be),  check out LSPedia's Exceptions Pilot. Accompanied by numerous partners, our program (launched January 2023) is working to identify, understand, and create procedures to resolve the new exceptions that will start to become common in the months ahead.

• LSPedia's OneScan Pharmacy Solution is the industry's leading tool for dispensers, featuring an easy-to-use interface and quick implementation time of 1-3 days. With this solution, we can get a dispenser started on DSCSA compliance for as little as $2 a day.

• In addition to rolling out a DSCSA solution, you’ll need your team to know what it means at the level of everyday business, and to be equipped with solutions for EPCIS errors. You may want to consider creating your own in-house DSCSA experts via LSPedia’s two-day DSCSA training sessions. These classes offer interactive, hands-on experience under the guidance of experts in FDA compliance, with limited class sizes to enable them to specifically address your organization’s needs.

If you still have questions on how to get started, contact us today or write to dscsa@lspedia.com.