HDA 2025 Traceability Seminar: FDA Emphasizes Readiness Over Perfection

In a video interview with Pharma Commerce, 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.

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

PC: How has FDA guidance evolved in the lead-up to this exemption deadline, and what do distributors need to know about regulatory expectations for enforcement?

Shankle: I don't work for the FDA, but I can kind of report the general vibe of what was said at Traceability and what's been said to us from the FDA over the past year, as these phased exemption periods have kind of expired out throughout the year. The FDA, just to back up, they've been holding these readiness town hall meetings for each of the different sectors about a couple months before each sector's exemption period expires. For manufacturers, their exemption period expired in May, they held it at some point in March. And for distributors, our exemption period will clearly expire on August of next week.

Our town hall was a couple months ago, and during that town hall, the general consensus from the FDA was, we expect readiness and we expect compliance, but they understand that compliance doesn't mean perfection, and those are actually pretty specific words for the FDA to use with stakeholders when we're talking about enforcement and inspections investigations.

They have said that they want to see you trying. One of our speakers at the Traceability Seminar, Abha Kundi, who was previously with the FDA not more than a month ago, actually spoke on stage. She had a great sort of poem or kind of mantra that she used, which was—and I'm probably going to get the words mixed up a little bit—but it was people, paper, and process. The idea was, are the right people in the know on what they need to know about DSCSA compliance and doing what they need to know? Do you have documentation? Do you have the paper that is setting up the SOPs, the processes that the people need to follow, and then are you actually following through on those papers? Are those people are actually doing what they say they're doing?

You can't just have documents. The FDA does not want to see you just have documents somewhere in the cloud that people kind of know is there when the FDA knocks on your door and you have to drag it down and go, oh yeah, but then nobody can explain how those documents work in practice. That's going to be a red flag for the FDA.