Compounding, consistent with the Food and Drug Administration (FDA) Extra-Label Drug Use regulations, is the customized manipulation of an approved drug(s) by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient. Common examples of appropriate compounding in veterinary practice are mixing two injectable drugs, preparing an oral paste or suspension from crushed tablets or adding flavoring to a drug. Compounded preparations are required to be prepared from FDA-approved animal or human drugs. The FDA and federal courts have held that federal drug laws prohibit compounding from bulk chemicals or raw pharmaceutical ingredients as such compounds are unapproved new animal drugs. For more information on compounding from bulk drugs, see AVMA policies on “Compounding from Unapproved (Bulk) Substances in Food Animals” and “Compounding from Unapproved (Bulk) Substances in Non-Food Animals.”
Compounding 101Compouding: Are you playing by the rules?