Types of Animal Compounding Activities that May Result in FDA Enforcement Action; If you have already violated any of these, you should consult an attorney for advice

 

What types of compounding activities could result in FDA enforcement action?



• Compounding a veterinary drug if an approved veterinary or human drug

exists to treat the diagnosed condition,



• Compounding drug products that are copies of commercially available FDA approved

drug products,



• Compounding when there is no valid Veterinarian-Client-Patient relationship,



• Compounding from unapproved drug products or bulk drug substances,



• Compounding veterinary drugs in anticipation of receiving prescriptions,



• Compounding of drug products in bulk using commercial scale manufacturing

equipment,



• Compounding drugs for use when the health of the patient is not threatened or

suffering or death may result from failure to treat,



• Compounding a veterinary drug from a human drug that has been removed


from marketing due to human safety concerns. For example, cisapride, which


is only available under a restricted distribution system.



• Compounding from a human drug for food-producing animals if an approved


food animal drug can be used. Due to food-safety issues, the FDA prohibits


the extralabel use of some drugs in food-producing animals. A list of these


restricted drugs can be found in 21 CFR 530.41.



• Offering compounded drug products at wholesale to other state-licensed


persons or commercial entities for resale,



• Labeling a compounded drug with a withdrawal time established by the

pharmacist and not the prescribing veterinarian,

 • Compounding veterinary drugs without regard to state pharmacy laws

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