Ann Donoghue, DVM, MS, a member of Epicur’s Advisory Council, shared her expertise and insights during a presentation at Illinois State Veterinary Medical Association Annual Conference, and now she’s sharing them on our blog!
Why does it matter where I get my patients’ veterinary drugs from? What do terms like cGMP and USP 800 mean? What’s the difference between a 503B outsourcing facility and a 503A traditional compounding pharmacy? Does any of this really impact my practice and standard of care? Epicur’s advisory council member, Ann Donoghue, DVM, MS, answered these questions and more in her Illinois State Veterinary Medical Association (ISVMA) Annual Conference presentation on June 3, 2021.
Ann combines her veterinary background with extensive experience in the pharmaceutical industry. She has 29 years working for pharmaceutical companies and almost 12 years of regulatory consulting experience. She is dedicated to helping veterinary organizations navigate the Food and Drug Administration’s (FDA) drug approval process, especially in product development, quality assurance, and managing regulatory affairs and interactions with the FDA.
We spoke with Ann recently, and she shared some insights into why it matters where veterinary hospitals and clinics get their compounded medications from and how it can impact patient care.
Is this a topic that you speak on regularly?
I’ve spoken twice on this topic. I’d love to talk about it more frequently because veterinarians just aren’t trained on this information—many aren’t familiar with how drugs are tested, evaluated, or approved, or how to determine if a drug is safe and sterile. It’s not part of a typical veterinary education program where the focus is primarily on what drug you need to use and why. There’s understandably a lot of confusion. The pharmacy can seem like a magic box and all these drugs just come out of it. But, how did the drugs get there in the first place? How do you know that the pill you’re giving today has the same potency as the pill you’re going to give tomorrow? As long as veterinarians can get the drugs they need, they might not think that where they get their drugs from impacts their practice, but it does.
So, why is it important to know where and how veterinary drugs are made? How can it impact a veterinary practice?
Well, compounding a drug is a bit like baking. Think about giving the same snickerdoodle cookie recipe to five different people. One batch of those cookies might be crispy, the other chewy; one batch might be overly brown, while another is undercooked; the amount of cinnamon coating might vary from batch to batch. If the recipe was doubled or tripled, the cookies may turn out very different because the recipe didn’t scale well. All of these people used the same recipe but got different results because their equipment and processes varied.
The same thing happens in drug compounding. How long did they mix the drug? Did they weigh it accurately, and is the scale calibrated correctly? Do they really know that what they’re putting together is the right amount of drug? If they’re making a larger batch of medication, did they modify the formulation appropriately? All of these factors can impact whether the drug will work as expected and may affect treatment outcomes.
When you have talked on this topic in the past, what has been surprising?
When I spoke at the American College of Veterinary Internal Medicine, I got questions about what compounding really is. What is the difference between a pharmaceutical from an FDA-registered facility versus a compounding pharmacy? 503B outsourcing facilities are completely new for the veterinary community and not fully understood. Not many know what is meant by cGMP, the current Good Manufacturing Practices required for FDA-registered facilities, either. cGMPs are the FDA regulations that all human and animal drugs are made under to achieve products that are safe, effective, and pure—503B outsourcing facilities must follow these regulations, but 503A compounding pharmacies do not.
Terms like 503A, 503B, cGMP, and USP can be confusing. What do veterinarians need to know?
503A compounding pharmacies compound prescriptions specific to individual patients; they can’t compound large batches for office use. They have to comply with state Board of Pharmacy regulations and guidelines set by the United States Pharmacopeia (USP), including USP <795> Pharmaceutical Compounding—Nonsterile Preparations and USP <797> Pharmaceutical Compounding—Sterile Preparations.
503B outsourcing facilities are different in that they can manufacture large batches with or without prescriptions to be sold to healthcare facilities for office use and administration. Like 503A compounding pharmacies, they are licensed or registered by state regulators, but 503B manufacturers follow cGMP and are held to a higher standard of compliance with the FDA’s regulations:
- These facilities are regularly inspected by the FDA.
- They must test to prove the potency and stability of every batch.
- They need to determine the beyond use date on their drugs instead of just referencing scientific literature.
- Environmental contaminant monitoring must be performed during every production shift in their primary compounding areas as opposed to every six months for 503A compounding pharmacies.
What do you hope your audience gained from your presentation?
I want people to come away with more concern and awareness about the safety and efficacy of compounded drugs. I hope they retain basic knowledge of what an FDA-approved drug is, and why knowing where you get your veterinary drug is important, so you can personally judge safety, potency, integrity, quality, and purity. I hope they won’t take for granted that what they’re getting from their neighborhood compounding pharmacy is what they think it is. Instead of just writing a script, having it filled, and ignoring it beyond that. If you’re using a compounding pharmacy, it’s important to know some things about it:
- When was the pharmacy last inspected? What kind of findings were there?
- Have you talked with them about whether they are testing their batches—do they really know that what they’ve compounded actually has the right amount of drug in it? Do they know if it’s really stable for the time period stated on the label?
How can veterinarians put these takeaways into practice?
One key step is for veterinarians to call the pharmacist where they most often get their drugs and plan a visit. Get to really know the pharmacist and develop a relationship. Ask them what kind of procedures they have in place and what processes they use when they compound your most frequently prescribed drugs. Get a tour and make sure they run a clean shop. If a veterinarian lives in an area with several pharmacies, develop a relationship with one or two that you trust and recommend those pharmacies to your clients.
Next, go online and check out their inspection results. Ask the pharmacist when their last inspection was and what the findings were. This is public knowledge for both 503A compounding pharmacies and 503B outsourcing facilities, so it should be readily shared.
Finally, remember that you’re obligated to prescribe the fully FDA-approved drug first. If that’s not available, for example, if you need a medication for tiny dogs, go with a 503B outsourcing facility, like Epicur Pharma, because they also have to follow all of the FDA’s requirements. Every single one of those drugs is tested—you KNOW that if the label says 5 mg per pill, it’ll be 5 mg +/- 10%.
If the outsourcing facility can’t meet your needs, then you go to the compounding pharmacy with whom you’ve established a relationship, so you have knowledge of what they’re doing and how well they’re doing it. There’s a lot of data showing that many compounding pharmacies are not doing a good job—their drugs have 20% too much of the active pharmaceutical ingredient, or 50% less than what should be there, or at levels that could be toxic. You really need that relationship with the compounding pharmacy to know they’re doing a good job; most try, but it’s really hard to make a drug.
Thanks, Ann! Follow our blog and social media accounts for future interviews and more insights.
Want to learn more about the differences between 503B outsourcing facilities and 503A traditional compounding pharmacies and why those differences matter for your practice? Catch Ann’s presentation at New York State Veterinary Medical Conference, October 1-3.