In recent days and weeks veterinarians have received communications from compounding pharmacies
regarding Congressional consideration of legislation on drug compounding. We, the Animal Health
Institute (AHI), have been prominently mentioned and mischaracterized in those communications. This
letter is an attempt to explain what Congress is contemplating and the policy positions we have taken.
Background
Animal drug compounding is the customized manipulation of an approved drug or drugs by a
veterinarian or pharmacist upon the prescription of a veterinarian to meet the needs of a particular
patient. AHI supports legitimate animal drug compounding.
Animal drug compounding from bulk active ingredients is not legal. While compounding pharmacies
dispute this fact, the law is clear, FDA has stated it is illegal and three federal appeals courts have ruled
that compounding animal drugs from bulk substances is clearly illegal. For a thorough discussion of why
it is illegal, see (our legal analysis).
Nevertheless, FDA does exert what is called “enforcement discretion” to allow some animal drug
compounding from bulk substances. This is generally necessary when there is a need for a specific
active ingredient and there is no approved human or animal drug with that active ingredient. AHI also
recognizes and supports these limited exceptions to the law in the interest of patient health.
In recent years, however, compounding pharmacists have performed drug manufacturing under the
guise of compounding. Using bulk substances they have compounded preparations in large quantities
and advertised them as cheap alternatives to approved drugs. They have compounded drugs that mimic
those of FDA-approved drug products. This widespread illegal activity has resulted in animal deaths –
including 21 polo horses in Florida in 2009 – and has undercut the FDA approval process. It is difficult to
justify the expense ofmillions of dollars and many years to get a drug approved by FDA only to find
compounders will circumvent the drug approval process andmake it from bulk so they can sell it
cheaply.
We also believe this activity places veterinarians, and more importantly their patients, at some risk.
Animal drugs compounded from bulk substances are illegal and they do not come with the proof of
safety and efficacy that approved drugs do. Both published research and FDA inspection reports have
documented inconsistenciesin potency and amounts of active ingredient in compounded products as
well as lack of sterility testing of these products.
Legislative proposal
AHI has asked Congress to consider a proposal that is more permissive than current law. It would legalize a certain amount of needed compounding from bulk active ingredients. It would do nothing to restrict current legal compounding – the pharmacy manipulation of approved drugs under a veterinary prescription to meet the needs of a particular patient. It would also provide a mechanism for medically necessary compounding from bulk substances where there are no approved products that will meet a medical need.
We have asked Congress to legitimize necessary compounding from bulk substances by directing FDA to create and maintain a list of products or substances that can be compounded from bulk while making it clear that all other, non-listed compounding from bulk remains illegal.
We have stated that we support exempting drugs compounded for minor species from this requirement, because we recognize there are so few approved drugs for these species and often their size and other factors makes treating them unique. We are not singling out any species as has been alleged. We also believe, as do other stakeholders including FDA, that compounding for food animals should be more restrictive than for companion animals due to the food safety implications.
There is great confusion in the marketplace today about the legality and use of animal drugs compounded from bulk substances. This confusion threatens animal health, creates unrecognized liability for veterinarians and subverts the FDA approval process. We believe Congress should address this situation by recognizing changes to current law are needed and AHI has suggested changes that we believe recognize current animal health needs.
You can find more information about drug compounding on our website. In addition, we are happy to talk about this issue with you and can be reached at 202-637-2440.
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