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Protecting Our Pets
Guidance for Industry #256: Compounding pharmacy fills many unique niches and unmet needs for both patients and providers. A good majority of that business is the creation of prescription products for animal purposes. Elephant suppositories, eye drops for eagles, antidepressants for wolves, the list goes on and on as animals require many of the same drug products that people do. The FDA has recognized this and approved many drugs for use in animals, but the wide variety of animal species make it a very hard thing to standardize. As this market grows, the grumbling begins from those who realize a bunch of animals are getting medicine that the FDA has not anointed.
Let’s get into an example: gabapentin is a very common medication used for nerve pain in both people and animals. It comes in several FDA-approved forms; capsules and tablets ranging from 100-800mg and a liquid product with a concentration of 250mg/ml. For humans, these products can cover almost every script that a doctor may write. When it comes to dogs though, a much lower dose is usually needed.
Most gabapentin prescriptions for canines are written for doses of 50mg or lower unless it’s a particularly large breed. This makes the commercially available and FDA-approved capsules useless since we cannot split them. Now you could easily make this dose with the liquid product, but the problem is most commercially made liquid gabapentin contains xylitol as an ingredient. Xylitol is FDA approved for humans as a food additive/sugar substitute but is extremely toxic to dogs. A small amount can lead to hypoglycemia and liver failure. Due to these reasons, compounded gabapentin is a frequent request either into lower dose capsules or a xylitol-free liquid.
For many moons, that is exactly what happened. Pharmacies compounding custom prescriptions for these animals from pure bulk gabapentin powder. The animals were happy, the veterinarians were happy, the pet owners were happy, heck, even the pharmacy was happy to fill a prescription that they would not lose money on at the end of the day. Now, good things don’t last and soon, one drug manufacturer, Greenstone, would figure out that there was money to be made with a xylitol-free gabapentin liquid. Once this FDA-approved product was available, those prescriptions now must be filled for the commercially available product by law unless the prescriber clearly annotates an acceptable reason not to use it.
Without xylitol as a sweetener, the taste can be rather off-putting and bitter, making it very difficult to administer to animals. There is one advantage though: the commercial product is more cost-effective, assuming you can get the animal to take it. If the animal refuses, well, now you’re stuck calling your veterinarian and asking them to send in a new prescription with proper annotations that would legally allow me to compound it. The patient is then stuck paying for the medicine a second time, but at least now I can flavor it like bacon.
That story illustrates that the FDA has the drug manufacturers’ financial interest above the patients’. The reason, of course, is that almost half of the FDA’s funding comes from drug manufacturers and the fees they pay to have their drugs approved. Like everything else, it is a pay-to-play operation: manufacturers scratch the FDA’s back, and in return, they are given the full power and protection of federal law to guarantee their market exclusivity. Essentially this same tale plays out with every drug, but unlike gabapentin, the market is rarely large enough to justify a drug manufacturer jumping in like Greenstone did with their liquid product.
When we compound something, it is the industry standard to use a bulk drug product, imagine a large jar of pure amoxicillin powder. If I did not have that available or if we’re going to throw it back old school and compound with whatever we have on hand, it can be done, but it will be more time-consuming for the compounder and thus more expensive. It will also be far inferior in taste and consistency because of all the additional inactive ingredients. I can spend hours grinding tablets in my pestle to achieve as fine a powder as possible and I still won’t get it anywhere near that pure powder. To really simplify this, imagine baking bread but instead of using flour we just rip up yesterday’s muffins and bake it again. Despite this being the most expensive, onerous, and inferior product, that is exactly what the recent FDA guidance document recommends should be done.
This has been brewing for years. GFI 230 first broached the topic in 2015, only to be thrown out and rolled into the new GFI 256 in 2020, but it has still faced intense pushback from the industry. It was supposed to take effect this past October, but that has currently been delayed until April of 2023. The FDA frames this as a safety concern; bulk products are not FDA-approved and therefore could never satisfy the requirements of the Food, Drug, and Cosmetic Act and thus are deemed unsafe. Perhaps you have read articles out there about sudden pet death from poorly compounded medicine, the sheer amount of hamster corpses the compounding industry leaves in its wake must have finally spilled over that fence protecting DC.
Or alternatively, hurting people’s pets is bad business and the insinuation that the standard of care veterinarians and pharmacists have been providing for decades is unsafe is horribly insulting to these professions. If there is an adverse event associated with animal compounded medications, the proper reporting involves filling out FDA Form 1932a. I have reached out to the FDA’s CVM (Center for Veterinary Medicine) to see if they could provide any information on just how many of these forms are submitted, because that will tell us if we have a problem or if they are simply gaslighting bureaucrats. They have not responded.
If the guidance document gets finalized, prescribers will have to up their prescription writing game and write on the face of every prescription the justification for not using the FDA-approved version. Acceptable things here are allergies to ingredients like dyes, binders, or preservatives. Unacceptable things, according to them, are costs or personal preference; economic considerations or personal preferences are not a valid medical rationale per this guidance. In reality, of course, if your patient cannot afford medicine, then they can’t obtain it, so in my opinion, it certainly can be — but not to the FDA. Don’t forget: just because you are the end consumer does not mean you are the customer. You could argue the FDA is simply trying to protect its customers and not even your pets are safe.
Jacob Hyatt Pharm D.
Father of three, Husband, Pharmacist, Realtor, Landlord, Independent Health and Medicine Reporter
https://substack.com/discover/pharmacoconuts
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Further Reading and References
https://www.fda.gov/media/132567/download
Published in General
Other than preventing vet prescribed drugs ending up in people, who cares what drugs are prescribed for pets? I trust my vet to be cautious and conservative in prescribing drugs for my dog; if you don’t trust your vet, get a different vet. I am sure my vet makes mistakes, but in general my dog has gotten great care. Most vets won’t prescribe shady stuff; if the vet does make a mistake only an animal dies, but the vet gets a bad reputation and looses customers.
A local compounding pharmacy supplied my horse de-wormer. Each capsule was appropriately dosed corresponding to my, er, horse’s body weight.
I have administered pills to unwilling dogs, cats, horses, cattle, and goats. The bacon flavoring is a wonderful idea. Also, carrot or alfalfa flavor.
What a racket. I expect animals are harder to diagnose and prescribe for in some cases. And when you find what you need suddenly you can’t get it.
The FDA cares nothing for lives or health or costs. It exists to stop people,getting treatment.
For those who have never had the joy of administering pills to large animals, Here is the commonly used Balling Gun. The one pictured is 27″ long.
The animal is held still (somehow) and the nose is raised to straighten the throat. The Balling Gun, with a large pill in the end, is inserted down the unhappy animals throat, to a point beyond which it can be spit up or coughed out.
Of course, at the other end of scale, one can use a finger to pill a cat. In either case, be prepared for collateral damage.
Best finger to use? Someone else’s.
Did you read the whole piece?
This is about when a person cannot get the normal meds needed by their animal to be accepted by the animal that needs them.
At that point, a compounding pharmacy needs to be called into play.
I have had many pets in my adult life, and out of maybe 12 animals I have owned, only one has needed a compounded pharmacy’s product. So it might not affect the average pet owner, but maybe one pet out of 12 or 15 or 20…
As Jacob explains: “If the guidance document gets finalized, prescribers will have to up their prescription writing game and write on the face of every prescription the justification for not using the FDA-approved version. Acceptable things here are allergies to ingredients like dyes, binders, or preservatives. Unacceptable things, according to them, are costs or personal preference; economic considerations or personal preferences are not a valid medical rationale per this guidance.”
This new legislation coming into play will go into effect late Spring 2023.
I have owned dogs through much of my adult life. I currently have two labrador retrievers. My policy has always been to minimize their exposure to vets and medications, in general. Vaccinations for the various ailments dogs are subject to being the exception. I have no trust in the FDA or any other federal agency, but over the years, my trust in vets has also declined.
Anyone who owns a dog knows that what were once reasonable charges for vet services have become staggeringly more expensive. Additionally, vets, like a lot doctors, are subject to fashionable trends. The latest trend is to be fixated on your dogs’ weight. However, they also find ways to increase the number of visits you make with your dog to up the costs.
I recently took my younger lab in for her rabies vaccine. The doctor claimed to have noticed an infection in her ear. He prescribed and sold me a bottle of Zymox for double what I could get it for on Amazon. Over the next four weeks he performed a number of procedures including putting a waxy substance in her ear to deliver a slow dose of whatever med he was using. He had to sedate her to get that in, and charged me accordingly. After the four weeks and somewhere in excess of $400 in fees, I decided that I was being taken for a ride. I bought the Zymox from Amazon and treated her regularly for a week after which she showed no signs of irritation of infection.
There is a reader board out in front of the vets office which I pass often on my rides. He changes the message weekly, and they all seem to suggest that your dog or cat needs to be tested for one imaginary problem or another. Most recently telling people that they should bring their dogs in to be tested for fleas. We are currently under the effects of a 8″ snowfall. There are no fleas anywhere to be found in the fields or lawns or anywhere else. If you don’t have them in the house, they aren’t going to show up on your pet for at least the next six months. In my opinion, the drug companies, the FDA, and the vets are all of the same stripe and colluding to make their businesses more profitable at the expense of foolish pet owners.
Dogs are remarkably tough creatures. They heal well from injuries if allowed to do so. Properly vaccinated they are resistant to all sorts of diseases and parasites. Babying them and worrying over every little problem is excessive and silly.