HDA 2025 Traceability Seminar: Closing Gaps in Pharma’s Supply Chain

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 are some of the other critical interoperability gaps that you see in today’s pharma supply chain?

Mayeski: I think one of the areas where the industry has to make sure that they understand the gaps appropriately is really on the dispenser side of things. We've spent so much time with manufacturers and distributors, repackagers, and for good reason, but with dispensers, there are a lot of them, and they run the gambit in terms of size.

You have very small, independent dispensers, all the way up to large, complex hospital systems that have multiple locations. They all have to meet their requirements for compliance with the law. I think diagnosing the industry, diagnosing where there are gaps and challenges for this community, is going to be really important.

One of the things about the dispenser community is a lot of the folks that maybe do some of the DSCSA work inside of a pharmacy, for example, have other responsibilities. They may have to work on inventory, restock shelves. There are things that they have to do in addition to maybe some aspects of DSCSA compliance. These pharmacies, even though they might be small in size, can be fairly complex in their operation. The industry—understanding where there are potential gaps in interoperability at that level—I think will be important so that we can have smooth execution, all the way from the top to the bottom of the supply chain.

I think the last thing, and this was highlighted during the conference, specifically when the representatives from the various boards of pharmacy spoke, is that bad actors are going to attempt to test the system. They're going to attempt to introduce counterfeit or adulterated product into the system, and it's important for industry to be able to acknowledge that that's still going to happen, and that they remain vigilant in their efforts to combat that, to make sure that the product that's in the supply chain is authentic, meets the stated label requirements, in that the industry is working together to really prevent that from happening. I think that's something that's really important for the industry to keep their eyes on.