Building It, Then Defending It: A Conversation With Patrick Carpenter, PharmD, JD

Building It, Then Defending It: A Conversation With Patrick Carpenter, PharmD, JD

Patrick Carpenter joined Boesen & Snow Law as an attorney this year, but his path to pharmacy law did not start in a law school classroom. It started on the floor of a compounding pharmacy he built from the ground up, where he learned firsthand what it feels like to need a lawyer who actually understands the business of pharmacy, and to struggle to find one.

Carpenter sat down with Boesen & Snow (BSL) to talk about that journey, the regulatory patchwork he now helps clients navigate every day, and what drew him to Boesen & Snow.

You started out as a pharmacist. What made you decide to also become a lawyer?

Patrick Carpenter: Honestly, it’s a feeling that followed me for a long time. I remember sitting in pharmacy school thinking, huh, should I have been a lawyer? That thought just stayed with me. Part of why I later got my master’s degree in drug regulatory affairs was that I thought understanding drug regulation more deeply would scratch that itch. It didn’t. If anything, it made me want to go to law school even more.

Two things really pushed me over the edge. The first was building a 503A compounding pharmacy from scratch and needing legal help I couldn’t find. I wasn’t connected to the pharmacy law community the way I am now, so I would call lawyers who said they were pharmacy law experts, and I’d spend most of the conversation getting them up to speed on things I felt like a real expert should already know. I remember thinking, if I can’t find a competent expert, maybe I have to become one myself.

The second thing was watching the industry live through one of those tragedy-then-legislation cycles that anyone in this field will recognize. The New England Compounding Center outbreak led directly to the Compounding Quality Act, which created the 503B outsourcing facility category and brought a wave of FDA scrutiny to state-regulated 503A pharmacies that hadn’t seen that kind of federal attention before. The number of compounding pharmacies in the U.S. dropped sharply in the years that followed. I was building a compounding pharmacy through all of it, so I wasn’t just reading pharmacy law history, I was living it. I wanted to be part of helping the industry implement that law, not just react to it.

Can you give an example of one of the complexities you help clients navigate?

Patrick Carpenter: Sterile compounding is a good one. Most states require 503A pharmacies to follow USP 795 and 797, and the current version of 797, specific to sterile, became official in November 2023. States phased in their own compliance deadlines, though. Florida, for example, didn’t require full compliance until November 2025.

So you end up with a pharmacy whose home state has one deadline, shipping product into a dozen other states that each have their own timeline and their own interpretation of the rules. That’s a recurring theme no matter what regulation we’re talking about, a patchwork of state-by-state requirements that makes compliance genuinely complicated. Very few compounding pharmacies today serve only their local, intrastate market. Most are shipping across state lines, which pulls in interstate commerce issues and FDA jurisdiction on top of the resident state’s rules and the destination state’s rules. I’ve seen a lot of clients get tripped up simply trying to answer the question, which version of the rule am I actually supposed to be following right now?

What advice would you give someone starting a compounding pharmacy today?

Patrick Carpenter: These are businesses, first and foremost, and running a compliant pharmacy and running a profitable one are not mutually exclusive. People do both, every day. The key is treating compliance as part of the business plan from day one, not something you bolt on later.

If you’re making a substantial investment in a 503A compounding pharmacy, or an even larger investment in a 503B outsourcing facility, you don’t want to find out eighteen months in, or after a few FDA inspections, that you’re facing a warning letter, a consent decree, or board of pharmacy discipline. Some states have mandatory suspension statutes. Virginia is one that comes to mind, where certain disciplinary actions in another state trigger an automatic suspension at home. That turns into a notification requirement potentially across every state where you’re licensed, it’s a hassle for a business, and it’s expensive.

I’d tell anyone opening a compounding pharmacy or outsourcing facility to keep compliance front of mind from day one. That’s what I did with the pharmacy I built, and I believe it saves money over the long run. It might cost a little more up front, but you have documented policies, your staff is trained to those policies, and there’s no guesswork when an inspector walks in the door.

Your bio talks about not wanting to just tell clients no. Can you unpack that philosophy?

Patrick Carpenter: That comes directly from my own experience looking for a pharmacy lawyer early on. I’d bring an idea to an attorney and the immediate reaction would be, no, you can’t do that. And that’s where the conversation ended. As a business operator, you’re left thinking, okay, so what can I do?

Pharmacy owners are running a business in one of the most heavily regulated industries there is, and at the end of the day, they care about patient care as much as anyone. My role isn’t to help anyone find a way around the law. It’s to help clients find the compliant path that actually gets them where they’re trying to go. If a client brings me an idea that isn’t compliant as written, I want to understand what they’re actually trying to achieve, because there’s almost always a way to get there, or close to it, while staying fully within the rules. There’s a perception that lawyers exist to say no. I think the more useful role is to be a business partner who helps clients build something that works, and that they can feel good about because it’s done right and their investment is protected for years.

You’ve been on both sides, the pharmacist getting advice and the attorney giving it. What’s a mistake you see clients make over and over?

Patrick Carpenter: It’s rarely about bad intentions. Even clients who do the right thing, who work with a compliance specialist or an attorney to build a compliant process and write it into a policy, often stop there. They treat the written policy like it’s the finish line, when really it’s the starting point. Writing the policy is the legal and regulatory piece. Training your staff to actually live it is the operational piece, and that’s where I see people fall short.

It’s one thing to have a policy. It’s another for your team to know how to act on it, and to be able to speak to it when an inspector walks in the door without it looking like the first time anyone on staff has ever read it. In an industry that’s inspected as often as this one, that gap between having a policy and living it day to day is where I see clients get hurt the most.

Why Boesen & Snow?

Patrick Carpenter: Mark and Allyson, honestly. I met Allyson at an American Society for Pharmacy Law conference, right after I’d been awarded a scholarship for my final year of law school. She reached out afterward, and we started talking. I was drawn to the entrepreneurial spirit at Boesen & Snow right away. I’ve always done well in small, entrepreneurial environments, and beyond that, Mark and Allyson are just an incredible resource. Between the two of them, they’re a storehouse of pharmacy law knowledge that’s genuinely hard to find anywhere else.

Boesen & Snow is one of a small number of firms doing this specific kind of pharmacy work at the level they do it. Given my operational background and my legal training, it felt like a natural fit. Practically, the work is broader here too. My focus used to be narrower, and now I’m getting exposure to more areas of pharmacy and healthcare law, which I think makes me a better, more holistic counselor for clients.

Who’s the client you’re the best fit for?

Patrick Carpenter: I do a lot, and I enjoy all of it. Telehealth prescribing and payment models. Import detentions for manufacturers and wholesale drug distributors. FDA 483 responses. State board of pharmacy responses. Questions for outsourcing facilities and wholesale drug distributors about who they can legally distribute product to. I do all of that and I like doing it.

But the question isn’t what can I do, it’s what am I the best at. Without hesitation, that’s sterile or non-sterile compounding pharmacy work. That’s the intersection of my operational background, my pharmacy education, and my legal training. If you’re a compounding pharmacy, whether you’re a 503A pharmacy starting with nonsterile bulk drug substance, a 503B outsourcing facility, or an infusion pharmacy mixing FDA approved products, Boesen & Snow should be your firm, and I should be on that legal team.

For pharmacy owners navigating FDA inspections, state board reviews, or the next round of compounding regulation, Carpenter’s message is straightforward: the law doesn’t have to be an obstacle. With the right counsel, it can be the thing that makes growth possible.

Want to connect with Patrick over a legal matter? CLICK HERE to schedule a consultation.