Compounding of Animal Drugs

In general, compounding an animal drug from an active pharmaceutical ingredient (bulk drug) is not permitted by the Act unless covered by an approved new animal drug application. This is true even if the compounder is a veterinarian or a pharmacist. However, CVM acknowledges the medical need for compounding may exist within certain areas of veterinary practice. The contemporary practice of veterinary medicine requires products to treat hundreds of conditions and diseases in dozens of species. Business and market realities in the animal health industry can only provide a fraction of products necessary for these indications. Consequently, veterinarians continue to require products to treat diseases or conditions in animals for which no FDA-approved product is available. Veterinarians must by necessity on occasion utilize products that are compounded to meet a specific patient’s medical need. Thus, the agency may exercise its enforcement discretion in not objecting to compounding from bulk drugs under certain conditions. Additional information on the FDA policy regarding animal drug compounding can be found in Compliance Policy Guide, Section 608.400, “Compounding of Drugs for Use in Animals,” (http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html).

Animal drugs may be legally compounded from FDA-approved animal drugs and FDA-approved human drugs if the compounding practices are in conformance with the provisions of the regulation on the Extra-label Use of FDA-approved drugs (See Next Section).