The American Veterinary Medical Association’s (AVMA) Executive Board recently approved three new policies to provide guidance on compounding to veterinarians and also legislators on Capitol Hill currently considering legislation on the issue.
“These policies are very important to our members and the animals they treat because veterinarians need compounded preparations in order to provide treatments to animals when drugs approved by the Food and Drug Administration (FDA) cannot be used,” explains Dr. Douglas G. Aspros, president of the AVMA. “Our staff in Washington is currently meeting with members of Congress to ensure that compounded preparations are available to our patients when they need them. These policies will help in that educational process, not only by providing guidance to legislators considering compounding issues and legislation, but by informing our members on what is currently legal.”
Compounded preparations are commonly used in veterinary practices across the country. Examples of drug compounding include mixing two injectable drugs, preparing
an oral paste or suspension from crushed tablets, or adding flavoring to a drug to get a patient to accept the medication. These compounds can be created at the veterinary practices or through a prescription by a pharmacist. However, there is clear differentiation between compounding that is medically necessary in non-food patients and the very limited compounding that is used in food animal patients.
The Executive Board passed one new policy on veterinary compounding, in general, and two on compounding from bulk unapproved raw active ingredients. The new, general policy on veterinary compounding offers recommendations on how to compound in a way that minimizes the risk for adverse events, but also advocates for additional uses of compounded drugs. For example, the new policy recommends allowing veterinarians to maintain compounds in their office stock of drugs for urgent and emergent needs.
The other two policies, which address compounding from bulk unapproved substances, state that there are certain circumstances when bulk compounded drugs are useful and necessary. The policies establish very clear differentiation between medically necessary compounding needs in non-food animals from the very limited compounding in food animals.
The FDA and federal courts have held that compounding from bulk unapproved raw active ingredients is prohibited under federal drug law. The AVMA’s two new policies on bulk compounding suggest how bulk compounding could be useful for veterinarians: