Kala Shankle, JD

HDA 2025 Traceability Seminar: A Final Push Toward Compliance and Future Regulatory Challenges

, Kala Shankle, JD,HDA’s vice president of regulatory affairs, discussed how this year’s Traceability Seminar brought together stakeholders from across the pharmaceutical supply chain, where the prevailing tone was one of pragmatic focus on the “last mile” of compliance implementation. Attendees concentrated on operational readiness ahead of upcoming regulatory milestones and discussed the real-world challenges that still stand between companies and full compliance with traceability standards.

While the FDA was unable to present formally, several former agency officials attended and contributed valuable insights, grounding the event’s discussions in current regulatory perspectives. One of the most well-received sessions featured representatives from various state boards of pharmacy, who detailed the tools and processes used in counterfeit drug investigations. In particular, they discussed the use of the HDA Verification Router Service as a key resource in identifying and mitigating threats to supply chain security.

Technical sessions also drew strong engagement, particularly those covering exception handling and barcode quality—issues that continue to cause friction in day-to-day operations. These conversations provided clarity on the ongoing technical and logistical barriers that stakeholders face as they work toward compliance.

Looking ahead, the seminar also explored what’s next for distributors and large dispensers beyond the 2024 deadlines. Discussions centered on the still-pending NDC Final Rule and the forthcoming national standards for wholesale and 3PL licensure, both of which are expected to introduce new operational complexities once finalized. These forward-looking conversations underscored a shared understanding across the industry: while compliance is within reach, regulatory evolution will continue to drive change—and collaboration—across the entire pharmaceutical supply chain.

Shankle also dove into industry’s overall preparedness for DSCSA compliance; how FDA guidance evolved in the lead-up to this exemption deadline; what distributors need to know about regulatory expectations for enforcement; and much more.

What was the general consensus on this year’s Traceability Seminar? Did any specific sessions catch your eye?

 I would say the overall tone of the attendees was very pragmatic and focused on the last mile of getting into compliance form. Unfortunately, the FDA couldn't present. They were in the audience, however, but we did have several recent FDA officials share current perspectives, which really kept the conversation grounded. 

You asked about standout sessions. There were several, I think that a lot of folks came away. We've had a lot of positive feedback from our members, but the some of the standout ones were we had representatives from various boards of pharmacy discuss the tools that they used, including aspects of HDA verification’s router service in counterfeit investigations. We also had lots of sessions on exceptions, handling, and barcode quality, which for the technical folks is something that really matters to them.

We really talked about where the real operational friction was, and then really there were questions about what's next, beyond this August for distributors and for bigger dispensers, in November of this year. That was really the NDC Final Rule, and the forthcoming and national standards for Wholesale and 3PL Licensure Final Rule, which neither have been finalized, but at some point, they will be, and they will present more conversations and more operational challenges for the entire supply chain. Those were also very well- attended sessions with lots of good conversation amongst stakeholders.

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Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how at this year’s seminar, attendees emphasized pragmatic approaches to achieving full compliance while anticipating upcoming FDA rules that could reshape wholesale and 3PL licensure standards across the pharma supply chain.

Kala Shankle, JD

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