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Compounding is a form of extralabel drug use. Therefore, the Animal Medicinal Drug Use Clarification Act (AMDUCA) and its regulations govern compounding for animals. Additionally, FDA shares it current thinking via a Compliance Policy Guide (pending revision).
In addition to these federal rules, state compounding rules apply.
For example, prescriptions for compounded drugs should be patient-specific. However, some states have a provision for in-office use of compounded products. These states allow pharmacists, under limited conditions, to fill a veterinarian's request for a non-commercially available compounded product if the product is to be administered by the veterinarian in his/her office. Those same states often prohibit a veterinarian from dispensing such drugs or selling the product to other veterinarians. Other states have no provision for in-office use or ban the preparation of products entirely for office use. Veterinarians should contact their state boards of pharmacy and veterinary medicine to determine their requirements.
Alternatively, your state veterinary medical association may have researched specific requirements. Find out how to contact your state veterinary medical association.
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= AVMA/SAVMA Members Only
