HDA 2025 Traceability Seminar: Pharma Supply Chain Nears Full DSCSA Compliance

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 prepared do you believe the industry is for DSCSA compliance overall?

Shankle: We've actually been able to track readiness fairly well here at HDA, at least between manufacturers and distributors. For over a year, we've been conducting what we call this monthly snapshot survey of our members, which really has been tracking just interoperable data exchange and the accuracy of that data exchange. And so this time last year—and I'm going to give you some rough numbers—we were around 75% of data coming from manufacturers to distributors was accurate data for a product, and it was at the purchase order level.

While that sounds maybe like a good number, that basically in practice, meant 25% of product did not have accurate data, and therefore could not move throughout the supply chain. So 25% of product not being able to move through the supply chain is a very, very big challenge. When the FDA granted exemptions close to this time last year, that gave the ability for the distributors and manufacturers to stabilize their data exchange and the accuracy of that data.

Every month, we kept seeing an increase in progress for the accuracy of that data. I can report as of June—which is the last time we took that snapshot survey—members were reporting somewhere around 97.5% of data coming from manufacturers—of course, this is a median—was accurate, so that is a very big jump in progress and compliance.

The overall tone at Traceability, and what we've heard from our members throughout this summer, is distributors are ready. There are always going to be challenges that are going to arise, but those challenges can be dealt with in an individual company basis. It is not something that we're seeing is industry or specific to the distributor sector. That's why you're not hearing a lot from HDA or its members on, you know, an extension needed for the exemption period that is going to expire on Aug. 27 so literally, next week. That’s a very good thing.

The other thing we heard at Traceability is that we did have some dispensers, specifically dispensers from larger chain pharmacies, participate in our series of panels that we had, and several of them noted too that while compliance challenges remain with data exchange coming from upstream, that they too are not interested in a sort of blanket extension of their exemption period, which would expire on Nov. 27 of this year. I even asked on my own panel that had these larger dispensers, do you think that you're going to need more time? Most of them said, we're going to work with our trading partners, but in terms of wanting to wait, that was not where they wanted to go as companies, that they wanted to, the phrase was, “go live.”

I think you're hearing the entire industry say it's ready to go live. There will be challenges. That is just the nature of law and regulations and enforcement of those laws and regulations, but the overall challenges of maybe 25% product not moving through the supply chain is not present at this time.