How DSCSA Compliance Is Unlocking Recall Efficiency

In a recent discussion with Pharmaceutical Commerce, Dan Walles, VP & GM, traceability and compliance solutions, TraceLink, explains that with the Drug Supply Chain Security Act (DSCSA) dispenser deadline fast approaching (Nov. 27), the divide between organizations that have fully operationalized serialized data exchange and those that are only minimally compliant is becoming increasingly clear. The strongest indicator of true readiness, he notes, is the ability to treat DSCSA processes as routine business operations rather than one-off implementation tasks.

Organizations that are well prepared have been working toward compliance for years, building DSCSA requirements directly into their standard workflows. For these companies, serialized data exchange is embedded into daily receiving procedures, supported by documented standard operating procedures (SOPs), robust training programs, and clearly defined exception-management pathways. Rather than treating exceptions as unusual events, these organizations expect them as part of normal operations and have established cross-functional awareness to ensure issues are resolved efficiently.

This level of integration, often referred to as “operationalization,” is the key differentiator. Mature organizations have moved beyond simply establishing system connectivity and instead, have focused on how people, processes, and technology work together to support DSCSA compliance at scale. Their teams are aligned, trained, and prepared for the day-to-day realities of serialized data exchange.

In contrast, companies that are only minimally compliant tend to focus almost exclusively on the technical connections required for DSCSA data transfer. Many of these organizations have only recently begun preparing, leaving little time to build the broader operational infrastructure needed for ongoing compliance. Without established SOPs, cross-functional training, or workflows for exception management, they risk facing significant disruptions when serialized data exchange becomes a daily expectation.

As the deadline draws near, the organizations that will succeed under DSCSA are those that understand compliance is not a checkbox, but rather, a fully integrated operational discipline.

He also shares the lessons he observed across thousands of dispenser go-lives, the definition of “true readiness,” and much more.

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

PC: As dispensers think about DSCSA compliance beyond the deadline, what ongoing processes or capabilities will be essential in the next phase of supply chain collaboration?

Walles: It's a question that leadership in a number of different companies have been asking their serialization and compliance teams for a number of years—is there business value that we can gain from the investment that they're making in compliance? I can tell you we're having some real fruitful discussions in that area.

The first area that I'll call out is recalls. I think in the area of recalls, and if you remember when DSCSA regulation was signed into law, part of the goal of the regulation was to give the industry the tools to execute recalls faster. The recall process today is fairly manual. It involves a lot of emails, postal mails, faxing—you name it—to try to inform the supply chain of when recalled products exist in the supply chain.

I think this will be the first area where you could start to see some real business benefit in being able to precisely identify where a recalled product might be in your organization. If you take a large health system or a large retail pharmacy who's doing receiving at a number of different locations, even for those organizations to identify have I received recalled product? If I have received it, where did I receive it?

Those are questions that before serialization and DSCSA were hard to answer, and usually required a team of individuals to go out into the warehouses or out to the pharmacy floor to see if any recalled product was there. Now, we have the tools and the scaffolding to first identify if recalled product has been received, identify, or at least narrow down the location as to where that product was received. We call it targeted recalls—being able to target the location more precisely of where recalled product might be, with the goal of retrieving that product off the shelf as fast as possible.