Is the Industry Ready for the DSCSA?

In a video interview with Pharma Commerce, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, describes how the HDA Distribution Management Conference (DMC) covers a broad spectrum of topics within the pharmaceutical supply chain, with a special focus on current regulatory and operational challenges. One of the major topics at this year’s conference was the Drug Supply Chain Security Act (DSCSA), which prompted several discussions and roundtable sessions.

The DSCSA has significant implications for the pharmaceutical supply chain, especially in terms of enhancing traceability, safety, and efficiency in drug distribution. At the DMC, various presentations and dedicated roundtable sessions were held to address its impact, compliance requirements, and the ongoing industry adaptations necessary to meet its mandates. These discussions provided insight into the challenges and solutions that stakeholders in the pharmaceutical supply chain are encountering as they work to ensure compliance with DSCSA regulations.

Overall, the DMC served as an important platform for exploring the evolving landscape of drug supply chain security, with the DSCSA at the forefront of many conversations. Given its complexity and importance, the conference highlighted the need for continued collaboration and knowledge sharing among industry professionals to navigate the regulatory landscape effectively.

Rowe also comments on where he believes the industry stands in terms of DSCSA readiness; some of the supply chain disruptions that stakeholders are reporting; and much more.

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

PC: Where do you believe the industry stands in terms of DSCSA readiness?

Rowe: The mood and sentiment from the conference this year was a little bit different in that most were saying that they were exchanging data at a much higher rate. Most of the distributors and manufacturers were saying, “we're fully connected with most, if not all, of our customers, and that data is actually moving,” so the pipes have been made. Data is moving through the pipes. Generally, the sense is that—again, not a formal survey—the success rate seems to be around 90% to 95%, so it's not only that data is moving, but it's moving at a much higher quality than what we saw this time last year.

The amount of improvement has been tremendous. I think the conference was less of an implicit plea to regulators, we need more time. We're going to be pitching for this delay. I think the sentiment was, we've got the delays that we needed. We have this phased exemption period moving throughout 2025, it's how do we now deal with the upcoming deadline. A 90% to 95% success rate is good on paper. When I was in school, that would have gotten you an A or an A-minus. That sounds pretty good.

When you put that in terms of the volumes in which we're dealing with in the US pharmaceutical supply chain, on a daily basis, that could mean 10s of 1000s of product potentially getting quarantined, and so there is still concern around the speed in which exceptions can get handled and fixed. That was a big part of the conversation at the conference as well, exception handling. It has been for years. I think it will continue to be the “hot topic” in our industry. I think there's acknowledgement that we're never going to get to 100%, but when an issue comes up, how do we quickly resolve it?