Dispelling Myths on Compounding

Confused about the various communications you’ve seen about what AVMA is or is not doing on compounding? We wanted to take a moment to dispel myths about compounding, as well as update you on the AVMA’s current activities on the subject.

• The AVMA is not being pressured by outside groups to take any actions on compounding. Veterinarians “in the field” (many of whom are practitioners) who serve on AVMA’s volunteer governance groups are discussing the current legal status of bulk compounds and reviewing AVMA’s policies on the topic. Part of that discussion is with various groups – including compounding pharmacy groups – to understand their perspectives.
• Catalyzed by recent human health concerns related to compounding, there is a sense of urgency to this issue due to Congressional interest in introducing and passing compounding legislation this year. Our Governmental Relations Division veterinarians utilize AVMA’s policies in communicating with members of Congress about legislation.
• The Food and Drug Administration (FDA) says nothing in its regulations permits compounding from bulk (raw pharmaceutical ingredient) drugs. It also has a Compliance Policy Guide on the subject. Some pharmacists might say otherwise, but AVMA is going by the FDA’s rules since they’re the federal authority.
• Compounding is necessary sometimes, but be cautious. We believe veterinarians should know that compounding, including formulation in a novel drug delivery system (e.g. transdermal), may impact the absorption and depletion of a drug. This may result in drug concentrations that are above or below the therapeutic range and lead to the development of an adverse drug event, including therapeutic failure.
• Compounds are not generics. Some compounds are manufactured and might even look like a generic drug, but could very well be an unapproved manufactured mimic (i.e., an ever-so-slightly different version) of an FDA-approved drug. There is typically a New Animal Drug Application (NADA) number or Abbreviated New Animal Drug Application (ANADA) number on FDA-approved animal drugs to help you determine whether a drug is approved or not.
• Clearly there are situations in which the need for therapy from compounding is great and the risk is small. Along with many other factors, liability is one to consider when contemplating use of a compound. For example, use of a mimic (a drug that looks like it’s approved, but really isn’t) could expose you to unnecessary liability.

Stay tuned as the AVMA’s volunteer governance groups continue discussing this topic that is so important in the daily lives of practicing veterinarians.

11 thoughts on “Dispelling Myths on Compounding

  1. I use compounded medications for my small mammal patients primarily. If they were not available, we would not have very many options for treatment. It is pretty difficult to pill a rabbit. I think the FDA has no idea what we do and the challenges we face getting medication into our patients. Even dogs and especially cats can be difficult to medicate, so having options at our disposal is imperative for us to be able to successfully treat our patients.

  2. With the FDA backorder problems, there should be a way to dispense bulk drugs to patients that require treatment. We use few compounded drugs, but we do use them and they have value. It is really difficult when the drugs we use are permanently backordered for whatever reason. The FDA and big Pharma should have an obligation to keep these products available or allow bulk product to be compounded until they are once again available through commercial channels.

    We also need to separate out compounding for individual animals needs and routinely used products that are removed from the market for whatever reason. It is two distinct issues and should be handled separately.

  3. Funny how no vet seems to be in favor of this. I’m sure this is going to lead to another government regulation with the state purpose of keeping us “safe”, when the true purpose is to line the pockets of big pharma. Sorry AVMA, I don’t buy it and neither do most vets. If you take this position against the wishes of most vets, then we’ll know where your loyalties lie.

  4. This is clearly another over reach from the FDA and big pharma. We all rely on compounding pharmacies to work around back orders and drug shortages. And the transdermal and flavor preps are something our clients appreciate and have come to expect. We use quality and proven compounding pharmacies, usually local or regional. I would caution the AVMA against supporting any restriction or limitation on the legal and judicious use of API’s.

  5. What are our options when a drug like prednisolone is on long term backorder? Our feline asthmatics would probably die without the daily compounded flavored tablets from a compounding pharmacy. Our practice was lucky when the phenobarbital backorder happened as we coasted through on 1000 count bottles. Then we ordered new bottles at 4x the cost. Our in State compounder for buprenorphine was out of production for 6 weeks from a knee jerk State Board of Pharmacy surprise inspection. Luckily they passed this ordeal with a great inspection. Our cats with chronic pain issues that cannot take NSAIDS had to buy the human product at 6x the cost.
    The worst and most wasteful of all the redtape is the reditribution of a leftover compounded drug to a patient that it was not made for. For example a 10ml vial of buprenorphine ordered for a cat spay (ahead of the surgery) which only requires 2.5mls total means the 7.5ml must be disposed of as Black box hazardous waste. To not use a pain reliever means the cat suffers and the State Vet Practice act is violated. You really want to fix this compounding issue than look at relaxing redistribution of a compounded drug within the practice that ordered it! As it is we are criminals for using the leftover and still good compounded drug in another pet. Maybe the AVMA can start to see the “in the trenches” problems going on with governments running wild.

  6. It is imperative that the AVMA not abrige the right of practioners to utilize the services of compounding pharmacies. Over the last few years there have been many instances where comonly used drugs have been unavailable do to backorder issue. Wihtout of the availablity to obtaincompounded replacements aniamls would suffer and possbily die. There are also instances where only compounded drugs will work. One example is food allergic dogs that need to be no heartworm preventive. With no unflavored preventives currnely on the market the option is to let the dogs be puritic or subject hem to the risk of heartworm infection. Another example is one a durg needs to be titered to the speciifc needs of the patient. I recnetly had a case with a small dog that needed to be on phenobarb, Teh pill sizes available did not meet the need to get his blood level in the proer range without resorting to splitting pills into eighthes. There hav ebeen many cases where owners were unalbe to get their cats to takes pills that have required our local pharmacy to compound a liquid suspension in order to save the cat’s life.

  7. We depend on compounded meds for the cats, especially. You all know that. I’m simply writing to say that I order compounded meds for cats at least 50% of the time I prescribe any medication. I remember cutting those 250 mg metronidazole pills in quarters, wrapping them in cream cheese and shoving down my cats’ throats (forget it if you don’t get it down the first time). And then there are those lovely doxycycline pills that cause esophagitis… I do tell everyone to follow any pill with a couple ccs of water, but the only way to guarantee that the stuff won’t get stuck in their esophagus if to have it in liquid form. And then there are the hyperthyroid kitties on methimazole who won’t take pills… And the kitties who won’t take ANY meds by mouth. What would we do without the transdermal meds, huh, huh? It ain’t broke and it don’t need fixin’!

  8. As a veterinary professional who treats dogs, cats, and exotics, I often rely on compounded preparations to meet the medical needs of patients. Limiting the list of bulk APIs available for use hinders my ability to provide medications that my patients can receive. Safety and bioavailability are of utmost importance. I rely on my well educated compounding pharmacists to provide the best compounds for the special patients that need them. I always use our local compounding pharmacy, not an out of state one. I believe it is important to have a close relationship with pharmacists who are addressing the unique needs of some of our patients. We have toured their facility and have met their staff. I emplore the AVMA to support continued judicial use of bulk APIs without limitations.