HDA 2024 Traceability Seminar: Legal Advice for DSCSA Compliance Teams

PC: You have an upcoming panel on “Legal Perspectives for DSCSA Compliance Teams.” What hard-hitting points will be discussed during the session?

Bernstein: It's a panel of four lawyers in a room full of supply chain experts. We've identified a couple of different issues and really want to get at it at a very high level for them [compliance teams]. The first and foremost issue is how important it is that if you or your supply chain trading partner are not ready, that you should be applying for a WEE. A WEE is a Waiver, Exception, or Exemption, and for the most part, trading partners should be applying for an exemption if they know that there may be some problems in moving the data, receiving data, or transferring the data to their trading partner. It may be that they're ready, but their trading partners aren't. This also includes how important it is to get a WE, which is something that you apply to FDA for, you explain why you need an exemption from certain requirements of DSCSA in order to be able to keep drug moving through the supply chain because it's all about making sure the drug gets continues through the supply chain to the patients when they need it.

Another area that we're going to be focusing on is how important it is to have SOPs, standard operating procedures. This is a no brainer because most of these companies should have SOPs in place, but the law requires you to have systems and processes, and that's all about having those processes in place, having them written down, training your employees on them, making sure that they follow those SOPs, and then training them again. That's a really important aspect of why that is important, because when FDA or a state investigator comes in, they're going to ask and look at what you are doing, and you can show them your SOPs, which are documented of how you are complying with the law.

Another aspect that we're going to be talking about is there was a Supreme Court case that came down earlier this year that impacts a lot of what FDA does, and it could impact parts of DSCSA. For example, what the case did is it changed the standard that courts will look at when they're evaluating whether or not FDA has interpreted a law correctly. If the law doesn't spell out how FDA has to implement it, previously, FDA would take a reasonable, rational approach. What this new court case says is it's up to the courts to determine if the law was interpreted correctly, and so how does that impact the DSCSA? It could impact wholesale distributor licensure rules that are in preparation right now. A proposed rule was published two years ago, and FDA will be finalizing it soon. What this means is FDA is going to look really carefully to make sure that they get it right, because they don't want a court to second guess them, and so that we're going to talk a little bit about that as well.