New policies offer guidance to legislators considering human/veterinary compounding laws
(SCHAUMBURG, Illinois) June 20, 2013—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:
● Compounding from Unapproved (Bulk) Substances in Non-Food Animals states that compounding from bulk is medically necessary in certain situations and should be allowed when the approved product is not commercially available (for example, during a drug shortage); when the approved product cannot be used to make the needed compound (for example, if the patient is allergic to the FDA-approved drug); or when there is no approved product from which to compound the needed preparation (for example, cisapride used for megacolon therapy in cats).
● Compounding from Unapproved (Bulk) Substances in Food Animals states that compounding from bulk should be allowed specifically for and limited to euthanasia, depopulation and poison-antidote compounding. If adequate scientific information is not available to determine a withdrawal time, which is the known duration of time it takes for a drug to adequately clear an animal’s system, the compound cannot be used in a food animal or the treated animal cannot enter the food supply.
The new AVMA policy on Veterinary Compounding replaces the Association’s previous policy on the issue, and the Association’s two new policies on Compounding from Unapproved (Bulk) Substances replace a previous policy on compounding from bulk substances.
For more information AVMA policies, please visit https://www.avma.org/KB/Policies/Pages/default.aspx, and for more information about veterinary compounding, visit https://www.avma.org/KB/Resources/Reference/Pages/Compounding.aspx.