One of the biggest topics of conversation at the HDA’s 2022 Distribution Management Conference & Expo was the industry’s impending—and required—adoption of the Electronic Product Code Information Service (EPCIS) standard for exchange of certain data. Because EPCIS offers a way for trading partners to exchange more granular information about the products they ship to each other, it will be required for serial tracing as of November 2023.
When the Drug Supply Chain and Security Act (DSCSA) became U.S. law in 2013, the product-level serialization requirements it set for entities along the pharmaceutical supply chain all but required a move to EPCIS without actually naming it. At the time of the law’s passage, EPCIS was six years old and still on version 1.0. It progressed to version 1.2 by 2016, a version that included the capability of declaring when previous events it had tracked were erroneous. It led to the knowledge that EPCIS, for all its improvements over EDI, has a high error rate.
In 2021, the 20 manufacturers and five wholesalers using EPCIS reported a 36% error rate on the 7,720 files processed between them. This is not an acceptable rate of failure, regardless of what the law says. The DSCSA is explicit in this regard: no buyers may accept shipments with any EPCIS errors. And it’s in that gap between the reality of a 36% error rate and the requirement of a 100% success rate that’s at the heart of the conversation surrounding pharma’s move to EPCIS.
Time Keeps On Ticking…
Regardless of any reasons for past delays, there’s no getting around the upcoming deadline: November 27, 2023. Pharmaceutical companies have already had to contend with another deadline back in 2017; this was to get everyone onboard with EDI in order to comply with the DSCSA’s requirements around lot-level traceability. This deadline was far easier to meet, as EDI is a much older and more battle-tested standard. It didn’t hurt, also, that traceability is far less complex at the lot level than it is for individual products.
But it’s not just the need to identify drugs at an individual level of sale; the requirements laid out by the DSCSA are also more complex, and EPCIS is currently the only standard capable of meeting them. It isn’t just a matter of being able to trace a pill from point A to point B. With EPCIS, each discrete movement is traceable—and auditable. This digital paper trail is a crucial part of DSCSA requirements, but there are still plenty of companies that haven’t even bought the metaphorical paper required.
And the Deadline is Sooner Than You Think…
While these companies that are lagging have heard the warnings, the lack of movement suggests they aren’t looking at the complete picture. At the time of this writing—April May of 2022— with 18 months to go before the FDA’s deadline hits and consequences of non-compliance are enforced. Anyone still waiting to get started on EPCIS implementation likely hasn’t heard that the onboarding process for DSCSA compliance takes, at best, six to eight weeks to complete. But it’s more likely to take many more months than that, so we’re already too late to get an early start.
It’s a cliche, but there’s no time like the present to get started on EPCIS implementation. That’s because “the big three” AmeriSource Bergen, Cardinal Health, and McKesson—sent letters to their trading partners in late 2021 letting them know that due to government deadlines they’ll be expecting compliance a full year in advance – Your future is already spoken for.