Regulatory Brief

 Bulk drugs

The practice of compounding drugs for use in animals: a complex issue that has been scrutinized more closely over time by various audiences including legislators and the media.

AVMA Response:

The AVMA recognizes there are not enough available drug products approved by the Food and Drug Administration (FDA) to treat all the medical needs of various animal patients across a wide range of species.

Compounding of FDA-approved drugs, when done in accordance with FDA's Extralabel Drug Use Rules, is legal. Compounding of bulk drugs (ie, raw active ingredients) is not allowed except for a limited number of poison antidotes listed within the FDA's Compliance Policy Guide on Compounding of Drugs for Use in Animals.

In an effort to help identify bulk drugs that are medically necessary to relieve animal pain and suffering in non-food animals, the AVMA Council on Biologic and Therapeutic Agents (COBTA) consulted its Clinical Practitioners Advisory Committee (CPAC) and AVMA allied veterinary medical associations, and provided some current thinking for the FDA regarding therapeutic drugs that, in limited medical circumstances in non-food animals, it believes may be appropriate for compounding from bulk substances if no FDA approved drugs are available and medically appropriate for the needed use.

It is important to realize that the needs for veterinary therapeutics are dynamic areas of veterinary medicine. That wide variety of domestic and non-domestic species treated by veterinarians and the diverse biology and physiology of these animals are routinely studied and therapeutic recommendations are often modified based on the individual clinical scenario. Therefore, omission of a therapeutic from the COBTA list should not be interpreted that use of bulk ingredients other than those listed is imprudent.

It is also essential that the COBTA's list of drugs is not considered all inclusive, as the list may change with time. COBTA recognizes that new animal drugs could be approved by the FDA, which could render components of the above list to be outdated. Circumstances may also exist in which an FDA approved drug may not be appropriate for compounding due to a variety of reasons including, but not limited to: concentration, solubility, concurrent ingredients, palatability, and availability. It is important to iterate that economics is not a justification for using bulk ingredients over FDA approved drugs.

Background Documents:

The AVMA responded on April 22, 2011. (PDF)