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 Animals5."
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 drugs6.
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