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U.S. Department of Health and Human Services

Animal & Veterinary

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Illegal Compounding of Clenbuterol

FDA Veterinarian Newsletter 2002 Volume XVII, No II

In 1998, FDA approved a new animal drug application (NADA) for Ventipulmin® Syrup, which contains a small amount of clenbuterol, as a restricted use prescription-only drug for treating horses affected with airway obstruction. When FDA approved the NADA for Ventipulmin® (sponsored by Boehringer Ingelheim Vetmedica, Inc.), several controls were put in place to ensure that this drug would not be misused in food-producing animals.

Ventipulmin® is the only clenbuterol drug product approved for use in the U.S. Ventipulmin® may only be used in horses not intended for food. FDA has special concern with clenbuterol, a beta-agonist drug that has been used illegally in the U.S. to enhance production of food animals. The use of clenbuterol in other countries has resulted in documented adverse reactions in humans who ingested meat containing residues of clenbuterol.

In recent years, availability of illegal clenbuterol formulations, produced as "compounded" drug product has increased steadily. The Animal Medical Drug Use Clarification Act (AMDUCA) permits compounding under very limited circumstances. Compounding must be done only on the order of a licensed veterinarian, based upon a valid veterinarian/client/patient relationship from approved human or veterinary drugs. In addition, other criteria must be met including establishing the need for a compounded product, and prohibitions against use of some drug products in food-producing animals. AMDUCA does not permit compounding from bulk drugs. Bulk clenbuterol should only be available for use by Boehringer Ingelheim Vetmedica, Inc. in the production of the approved clenbuterol product.

When an approved product is available, a compounded product is not permitted to be used unless it meets the criteria in AMDUCA. Since there is an approved clenbuterol product available, only limited compounding from approved Ventipulmin® is permitted. Clenbuterol products that mimic the approved product are unapproved new animal drugs and are not legal for preparation, sale, and use.

Veterinarians and animal owners should be aware that these unapproved clenbuterol products have not been shown to be safe and effective and may not be prepared under conditions that are controlled to produce a consistent, quality product. Prescribing, purchasing, or distributing "compounded" clenbuterol is in violation of Federal law. Veterinarians ultimately assume responsibility for the efficacy, safety, and composition of drugs prescribed in this manner.

During the past two years Boehringer Ingelheim Vetmedica, Inc., working cooperatively with the FDA, has been investigating this activity and has provided information demonstrating the existence of compounded clenbuterol products are merely copies of the safe and effective FDA approved veterinary drug product readily available to veterinarians. FDA will consider enforcement action for any preparation, advertising, sale, and use of unapproved clenbuterol.

Responsible compounding pharmacies have the potential to provide a necessary service to veterinarians and their clients by providing useful drug formulations in the absence of FDA-approved pharmaceuticals that meet the specific therapeutic needs of the patient. While some compounded drugs may have a place in veterinary practice, compounded clenbuterol, except in very limited circumstances, does not. A FDA-approved clenbuterol hydrochloride product is available.