Expect an explosion in EPCIS files ahead of November 2023.

Is your organization ready for an explosion in EPCIS data? Find out what EPCIS is, why EPCIS volume is increasing massively, and how to be sure you're ready to handle a wave of exceptions.

Getting up to speed on EPCIS

In July 2022, the FDA revised its 2014 guidance with new standards for the information exchange necessary for product tracing. In addition to phasing out the use of paper transaction records, the guidance made the long-awaited recommendation that 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 existing uptake.

The FDA's guidance document emphasized that pharma businesses ought to “make a collaborative effort” to follow the shared standard. Though the release found it unreasonable to expect all trading partners to “rely upon a single technological approach” to achieve this, it recommended that they move forward by accepting the EPCIS standard, with additional systems and practices as necessary. The move supported 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.

This made an impact, clarifying that trading partners who ignored EPCIS risked damaging themselves and their partners. As LSPedia CEO Riya Cao said a few months after the release, “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:

• 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.

Now that we've reviewed what EPCIS is and why it's starting to be used across the prescription drug supply chain, get ready for:

A data 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 about to increase massively in volume, taking the pharma supply chain by storm.

In January, LSPedia found that total EPCIS exchange volume in the Test Environment -- where manufacturers test their EPCIS exchange with wholesale customers -- had increased fifteen-fold the previous month. Where volume had been steady at around 1,000 for months, suddenly 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 a file will be generated for each individual saleable unit. Our rough estimate is that, overall, this change will eventually increase overall file exchanges by 100 times.

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 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.

What to do next

Find effective resources, and find them soon! LSPedia’s mission is to make DSCSA compliance easy and stress-free for any pharma trading partner. Our team can get any business onboarded with EPCIS data -- and improve their operational efficiency -- but we can't extend the deadline or add more time before November 2023. Start early to save yourself some stress. Here's a few places to start:

• ‍‍If you're concerned about exceptions, it's a good idea to 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.

• Making this possible is LSPedia's industry-leading Investigator technology, 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.

• 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; we 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.