LogiPharma USA 2024: Working Toward DSCSA Compliance
With the Nov. 27 deadline fast approaching, is the pharma supply chain ready for full data exchange?
We at Pharma Commerce take pride in reporting extensively on the latest surrounding the Drug Supply Chain Security Act (DSCSA), as it continues to gain more and more relevancy as the deadline for official enforcement—Nov. 27, 2024—is nearly upon us.
A keynote panel discussion at this year’s LogiPharma USA in Boston—which was centered around “Ensuring DSCSA Compliance for the November 2024 Deadline”—sought out to do exactly that. With Anshul Agarwal, principal at ZS Associates facilitating the discussion, he was joined by Riya Cao, founder and CEO, LSPedia; Elly Ensby, associate director, comparator sourcing, clinical supply chain, J&J Innovative Medicine; Sean Murphy, senior manager, manufacturer operations, Cencora; and Mark Karhoff supply chain & DSCSA consultant, National Association of Boards of Pharmacy (NABP).
At last year’s LogiPharma USA, the “stabilization period” had already been announced for several months, and industry was faced with the pressure of how to meet that timetable; now, the challenges have continued. Essentially, the FDA had said that the agency “does not intend to take action to enforce,” until Nov. 27, 2024, rules on exchanging product transaction data, reporting such data to regulators, or verifying salable returns against transaction data (apart from existing methods of verification), which has been referenced as a “stabilization period.”
How ready is the industry?
According to Cao, manufacturers are currently the most prepared and she illustrated as one moves further down the supply chain, the level of preparedness decreases. This signifies that dispensers who sit in the last mile of the functional supply chain arguably are the least ready for this regulation.
“The reason I say that is because every trading partner depends on their supplier to provide data,” she said. “We see this waterfall of less and less in that kind of fashion. But overall, the industry has been so much more active than what we've seen years ago, so I would encourage everyone to continue down the path of getting your training partners and data connections going, because we really have a single benefit. It provides visibility, and it really helps with understanding not only supplier performance, but getting that feedback from customers as well.”
Ensby, who was able to provide a clinical trial perspective, noted this chain reaction effect is very much a reality; it is a matter of being properly aligned with procedure. “It's a snowball effect—I think what’s important for us to see is, how we best collaborate, and how do we really quickly understand what the procedure is and what are business processes are for whoever's immediately before us on the supply chain, so that we can then align our processes,” she said.
Federal- and state-level nuances
Agarwal raised a great question directed toward Karhoff—what are some of the nuances in terms of regulation when it comes to the different levels of government?
“It was an education for me moving more to the pharmacy side; I started out with manufacturers early on in DSCSA, he said. “For anybody that hasn't worked with that side of the supply chain as directly, the state boards of pharmacies are critical. Obviously, there's different things to regulate depending on the state. Either some of them may have a branch for wholesalers, but they're critical in terms of them being the ones who are typically going into the pharmacies, doing the inspections. They all have different policies. They generally try to align on things. But what I've seen the last few years is that there's a huge uptick in terms of wanting to understand DSCSA, beginning to get ready for it, beginning to educate. There's a lot of education going on in a lot of the states right now, but it also depends on the state's resources.
“We've heard some of the states have really not even had regulators that long, because they weren’t within their budget. There are things that are out of their control. They also have to enable policies at their state level as well, which a lot of times, requires them going through their house and senates at that level.”
Murphy added an interesting point to be aware of: he explained that FDA has mentioned multiple times that they are prioritizing education over enforcement for the time being, but stakeholders need to be aware that that's not going to last forever; it’s best to ask them sooner rather than later if questions are arising.
Further, if members of the supply chain are concerned about compliance, a WEE, or Waiver, Exception, or Exemption (WEE) request, is also a valuable tool and those are evaluated by the FDA on a case-by-case basis.
As noted in previous conference coverage, a WEE should explain:
- What specific DSCSA requirements you need relief from
- What you’ve done so far/progress that’s been made
- Why you are requesting more time
- Why this specific request won’t create an issue for downstream trading partners.
- Ways to maintain supply chain security
Reference
Agarwal A, Cao, R, Ensby, E, Murphy S, Karhoff M. Ensuring DSCSA Compliance for the November 2024 Deadline. September 23, 2024. LogiPharma USA 2024. Boston.
