LogiPharma USA 2024: DSCSA Compliance Preparation

PC: You were just on a keynote panel discussion about insuring the DSCSA compliance deadline. What were the main highlights of the presentation?

Karhoff: So basically, it was to talk about the DSCSA, where we're at as an industry, what challenges are left, and also to educate people that maybe aren't as quite familiar with it. So, you have some people that aren't directly involved such as third-party logistics handlers and freight forwarders, things that may kind of touch it onto the side, but really it was just to spread some information around what's happening with DSCSA and how we look going into November.

PC: Where do things stand in terms of DSCSA compliance preparation?

Karhoff: I think it depends on what part of the supply chain you're in. As you think about manufacturers, they've been pretty prepared. From what we've heard from especially the whole the big wholesalers, I think they're all saying over 90% to 95% already. There are issues that they’re working through, but generally, the manufacturer side is prepared. There’s always going to be some outliers. The big distributors seem like they've done a lot. They've been working at it for a long time. I think on their inbound side, and things are coming up their outbound side. They’re trying to get data through their systems. I’ve heard numbers from 40% to 60% of data of data coming out the other side of their systems. When you think about secondary distributors, they are less prepared because they haven't been getting as much data from those primary distributors such as pharmacies.

The good news is that the big retailers and hospitals have been very present the last several years, and you're starting to see sort of smaller and smaller engaging now.

PC: Where do you think the FDA is at in reviewing waivers and exemptions?

Karhoff: They probably need to do something soon, because if they're going to issue exemptions, companies are going to need time to react to that, especially to let their trading partners know and get them ready. If they're not, it's making people more and more nervous, especially the ones that haven't been able to get ready because of trading partners and things like that. My hope is that in the next month, we'll hear something before we get out of October, hopefully not later. On the positive side, I think it has been applying pressure where it needed to. So, you are seeing more stakeholders engaging because they're realizing the state does not seem to be moving now. I think it is bringing attention to where it needs to be, but I think there's more people getting nervous.