FDA Registered 503B Outsourcing Facility

Meet Epicur’s Advisory Council: Q&A with Ann Donoghue

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Combining her veterinary experience with nearly 10 years of regulatory consulting, Ann Donoghue brings a unique and valuable perspective to Epicur’s Advisory Council. We recently spoke with Ann to learn more about what she’s seeing in veterinary pharmaceuticals and what 503B outsourcing means for veterinary hospitals’ stocking and dispensing processes.

Ann, thanks for talking with us. Tell us a bit about your background.

I am a veterinarian and I’ve been working in the pharmaceutical industry my whole career. I’m doing product development, regulatory affairs, and quality assurance — everything from conducting clinical trials to writing the regulatory documents, interacting with FDA, and inspecting manufacturing facilities.

Since I’ve been on my own as a consultant — which is about 10 years now — I’ve been working primarily with small pharmaceutical companies and startups that don’t have their own regulatory group. I do all the interactions with FDA and help them set up their strategy for drug approval. I guide them through the right protocols, oversee studies, and then pull everything together for the submission and approval.

What are you seeing in the veterinary drug market this year?

Pharmaceutical development has been constant. I have been quite busy finishing up some big studies that are getting ready to be submitted for approval. Probably the biggest changes are the continuing consolidations of animal health companies.

How has 503B outsourcing impacted the veterinary pharmaceutical landscape?

It’s an exciting change, and manufacturers like Epicur are really embracing the concept. 503B means that these facilities are essentially functioning like real drug companies with full GMP, or good manufacturing practice, standards. It’s not a pharmacist in a back room with a single hot plate, a scale, and a few vials. There are a lot of big 503A pharmacies, but they aren’t held to the same sterility standards or testing requirements.

With 503B compounding, you’re going to know what you’re getting. You’re going to know how long it’s truly stable for, that it’s been packaged properly, and that it really is sterile. A 503B must prove sterility. That’s a bonus for the veterinarian who is looking for something compounded that needs to be sterile that they can’t otherwise get. They can trust 503B outsourcing facilities.

Another bonus of 503B manufactured drugs is the ability to pre-order — I will know the expiration, I know the quality, and I can have it on my shelf. This means that I can actually prescribe it and give it to my pet owner right there as they walk out the door.

How much awareness does the veterinary community have around 503B drug manufacturing?

I think 503B is a hidden gem. I don’t think many veterinarians understand the whole process of what it means to get a drug approved, or what it means to manufacture a drug under cGMP. I would guess most veterinarians write a script for a compounded drug, and don’t think much about the quality or the pharmacy where it will be compounded. They trust it’s going to be fine and the patient is going to get the drug they need. Unfortunately, that’s not the case with all pharmacies. As the 503B drug portfolio grows, this offers veterinarians a lot of high-quality options.

What trends are you watching in the industry?

I think the biggest change practices need to navigate is how you manage your patient visits, your owner client experience, and your employees. One of the top ones is curbside service and the challenge to do that well. The owner is not in the room with you, and you can’t talk to them in real-time. While you’re doing a physical exam, you’re frequently talking to the owner to gather more information about what’s happening with the pet. Even if it’s just a routine annual visit, you still do a full physical. Veterinarians are working hard to maintain their standard of care in a new model.

Thanks, Ann! – Continue following our blog to hear more from our Advisory Council.

For more guidance on why 503Bs make a difference in veterinary medicine, download our white paper:

The Importance of cGMP (503B) Compounded Drugs

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