HDA 2024 Traceability Seminar: Filing Waivers, Exceptions, and Exemptions

PC: You recently spoke on a panel regarding “Filing Waivers, Exemptions, Exceptions: Lessons Learned – and other HDA Perspectives on DSCSA Implementation and Readiness.” What was discussed during the session, and what questions did the audience raise?

Gallenagh: I did the panel—it was myself and also two of my colleagues, Tish Paul from OFW Law and Brian Waldman from ArentFox Schiff. We work together a lot on these issues, and have worked together for years. We talked about the WEE process, or waivers, exceptions, and exemptions process, just in terms of this being a tool that is written into the statute for DSCSA. It's something that's available. It's something that FDA has encouraged. We talked about the need for timely decisions about WEEs, as well as some of the complexities—even if a WEE is granted, there are also additional complexities with managing those, so in addition to the WEE process, WEEs themselves, and where FDA is on all of that, we talked a little bit about HDA’s positioning right now, given our members’ focus on implementation and what we're seeing in the industry, just at least in the distribution sector, which really does provide us with an eagle's eye view, both upstream and downstream.

That’s kind of unique. We really just wanted to share with the audience what we're experiencing. Then, we conducted some Q&A, where we got some good questions about some very technical things that folks are grappling with, such as transition or grandfathered product, SOPs, or what a pharmacy do when they have a patient in front of them and no data with their product transactions. It was pretty diverse in terms of the topic or subject matter. We originally started out doing just what we had planned—the WEEs—and then, as we got closer and closer to the date for the presentation, realized there was just so much going on right now.