Sunday, September 9, 2012
FDA's Position on 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. Consequently, veterinarians continue to require products to treat diseases or conditions in animals for which no FDA-approved product is available. Generally, FDA will defer to state authorities regarding the day-to-day regulation of compounding by veterinarians and pharmacists of animal drugs. In limited circumstances, the agency may not object to compounding from specific bulk drugs under specific conditions. However, FDA will consider enforcement action when the activities of veterinarians and pharmacists are clearly outside the bounds of traditional pharmacy practice and are instead more akin to those of a drug manufacturer. 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."
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.
Quoted from FDA website found here.