HDA 2025 Traceability Seminar: Pharma Industry Shows Strong Readiness for DSCSA Enforcement

In a video interview with Pharma Commerce, Ullrich Mayeski, community engagement director of health with GS1 US, discussed how last month’s HDA Traceability Seminar received positive feedback from attendees, who emphasized both the quality of its organization and the timeliness of its content. The event, held annually, was noted for effectively addressing the current challenges facing the pharmaceutical supply chain. One of the greatest strengths of the seminar lies in its diverse audience, which brings together manufacturers, distributors, dispensers, solution providers, and professionals from varying organizational levels. This diversity facilitates meaningful conversations, both within sessions and informally, helping stakeholders compare challenges, share strategies, and build valuable relationships across the industry.

This year’s seminar differed from previous ones in tone, shifting toward a stronger sense of confidence and readiness. Manufacturers, in particular, appear to have made significant progress in providing data and resolving technical issues. Distributors also displayed greater assurance in their preparedness for the approaching regulatory requirements. While inbound processes seem relatively stable, outbound operations continue to present challenges, particularly in ensuring compliance on the dispenser side. Attendees observed that dispensers still benefit from certain exemptions, especially regarding the receiving of electronic data, which provides them additional time and flexibility.

The broader industry discussion is now less about uncertainty and more about refining readiness for enforcement. Attendees pointed to three major themes gaining traction: exception management, governance, and compliance execution. Exception management focuses on how companies will address inevitable discrepancies or system errors. Governance relates to setting consistent policies and practices across supply chain partners to ensure compliance. Overall, the event reflected an encouraging trend: the pharmaceutical supply chain is moving closer to readiness for the upcoming traceability enforcement deadlines, with conversations now centered on fine-tuning systems rather than questioning their feasibility.

In separate conversations, Mayeski also dives into panels they participated in at the conference; industry’s preparedness for DSCSA enforcement; best practices stakeholders should adopt to ensure secure, end-to-end traceability and interoperability; and much more.

A transcript of his conversation with PC can be found below.

PC: What do you believe industry’s preparedness is for DSCSA enforcement, now that exemptions have either already passed or are approaching?

Mayeski: From my perspective, I think it's actually pretty good. We’ve got to remember the industry has been at this for some period of time—over a decade together—collaborating on the best approach to capture this data, manage it, and then exchange it properly between the parties. Truly trying to get to a point where we've got interoperability, and I think generally, the industry has done a pretty good job with that.

I think the challenge will be making sure that the entire supply chain is at a consistent level of readiness. What I mean by that is manufacturers—they've already had their exemption that's passed. Distributors are in a pretty good place for the end of this month. But then there's this category of dispensers that physically, probably the largest category of folks, and so making sure that there's engagement on their level to understand the preparedness for where they are, so the partners in the supply chain can help with that, solution providers right there are a venue of folks that can assist with that.

Generally, I think based on the feedback from the sessions within the conference, folks generally felt pretty comfortable with the industry's level of preparedness. A lot of the issues that were talked about were what I would consider known issues, so something like barcode quality. A scanner that doesn't work properly, that doesn’t function properly, and can't scan something. Some of these are known issues that the industry already has steps to put in place.

There wasn't a lot of discussion about, hey, this is a new, novel issue that the industry has to tackle before—it's going to affect our preparedness. I think overall, it feels pretty good. I think the last thing I'd say on that is this industry has done a really nice job of keeping open lines of communication with each other. I haven't seen any evidence of that dissipating or slowing down. In fact, it's getting better, so how and through what medium partners connect with each other has been something that's been really well done within the industry.