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Nicholas Saraceno is Editor of Pharmaceutical Commerce. He can be reached at nsaraceno@mjhlifesciences.com.
At the conference’s milestone 20th anniversary event in Boston, experts unpacked the final stages of DSCSA implementation, highlighting pharmacy compliance challenges, state-level variability, and the role of technology in securing the pharmaceutical supply chain.
This year marks a special occasion for LogiPharma USA—it’s 20th anniversary.
Day 1 of the conference from Boston kicked off yesterday afternoon, and it certainly did not disappoint. After moderating a fireside chat of my own on end-to-end visibility earlier in the day, I was able to attend a thought-provoking panel discussion on “DSCSA Readiness: Ensuring Compliance and Beyond.”1
Moderated by Rohit Kilaru, director of pharma life sciences supply chain, PwC, it featured several subject matter experts in the space including Matthew Hoover, director of pharmacy procurement and logistics, Cleveland Clinic; Ellyn Ensby, associate director of comparator sourcing, clinical supply chain, J&J Innovative Medicine; Rose Campasano, vice president of industry relations; LSPedia; Mark Karhoff, contract with the National Association Boards of Pharmacy (NABP); and Matt Campasano, founder and principal consultant, Criterion Consulting.
DSCSA stands for the Drug Supply Chain Security Act, and is enforced by the FDA. It was originally signed into law as part of the Drug Quality and Security Act (DQSA) in November of 2013 as a way to help bolster security and traceability of products passing through the pharma supply chain.1
Essentially, it was designed as a unified federal standard for pharmaceutical drug tracing, giving manufacturers, distributors, and dispensers steps to establish an interoperable electronic system to identify and trace prescription drugs at the package level to prevent harmful drugs from entering the US drug supply and protect healthcare providers and patients from counterfeit, unapproved, or potentially dangerous products.
On Oct. 9, 2024, the FDA issued an exemption for eligible trading partners that will continue to delay enforcement regarding compliance with the law’s final enhanced drug distribution security requirements. All of those deadlines have since passed, except that of dispensers with 26 or more full-time employees who have until Nov. 27, 2025, while small dispensers, are exempt until Nov. 27, 2026.
“Theoretically, deadlines have been happening all this year. The exemption periods are rolling out. … What we are seeing right now is pharmacies trying to figure out what manufacturers and distributors have known for quite some time, DSCSA is a compliance challenge,” explained R. Campasano. “There's a lot to know. There's a lot to learn. … It's an interesting dynamic that's happening, but the road has been long. It's been challenging for every part of the industry, and so now we're finally sitting there at that last stage that we have to get through.”
Having said that, the DSCSA panel touched upon quite a few different topics as it pertains to this legislation. The KOLs explored the final phases of implementation, with particular attention on pharmacy preparedness and compliance hurdles.
From the NABP perspective, given the federal and state regulations that come with it, the organization’s mindset was to adapt a “wait and see” approach of monitoring the FDA.
“I think first it was really kind of following the FDA, seeing what the FDA was doing with the guidances and these, exemptions, exceptions, and delays, but now, they're starting to step up a little bit. There really is quite a diverse set in terms of what the state does, what their policies are like, and how they regulate,” Karhoff explained. There is quite a variety—some states have a very established and central regulatory process. Pharmacies might have to comply with some of the inspections a year. Other states, it's a little bit undeserving. They don't have quite the budget. The other fascinating thing is, just seeing who controls the licensing within the state can be really varied a lot.”
According to M. Campasano, there have been various developments in the space now that did not exist previously, is the publishing of warning letters being published and seen downstream.
“The FDA and regulators are looking now, which also corresponds to the fact that your downstream trade partners, or at the pharmacy level, they are looking at the data. Now that's associated with DSCSA. Five months ago, three months ago, even two months ago, that wasn't the case really. The majority of my clients today are either wholesale or manufacturing, and they were sending data downstream, and that was it.”
As for clinical supply chain stakeholders, they are starting to better understand their responsibilities under evolving regulations. Questions around ownership, data management, and compliance, combined with manual, error-prone documentation processes, are reshaping how sponsors, sites, and partners view their roles.
“The thing that’s changing is partners in the clinical supply chain are recognizing that they have a role to play,” noted Ensby. “There's always an art and a way of reading a regulation and identifying your definitions and where you fit in and how it impacts you. What counts as that transaction? Where are we seeing a change in ownership? Who actually has responsibility for managing, maintaining, storing the data? Is that the sponsor of the clinical trial, is that the person or the entity doing the buying? Is it the receiving location? What are those obligations?
“The other thing that we see is a lot of the documentation in EPCIS file—the human readable report that you're getting—is based on a manual process that's human dependent, so not only garbage in, garbage out, but also humans made mistakes and so the likelihood that you're going to see those errors increases.”
Other main themes that were expressed throughout included:
The panelists also emphasized how solution providers can boost efficiency and traceability through technologies like AI and advanced analytics. The verification router service (VRS) was also cited as being critical for confirming product authenticity, while stressing the need for standardized SOPs to guide product tracing and suspect product management.
References
1. Kilaru R, Ensby E, Campasano R, Hoover M, Karhoff M, Campasano M. DSCSA Readiness: Ensuring Compliance and Beyond. September 29, 2025. LogiPharma USA 2025. Boston.
2. Saraceno N. Top Questions Regarding the DSCSA. Pharmaceutical Commerce. August 25, 2025. Accessed September 30, 2025. https://www.pharmaceuticalcommerce.com/view/top-questions-regarding-dscsa