Extra-Label Drug Use

Published on: 10:19AM Feb 06, 2012

A recent announcement by the Food and Drug Administration (FDA) regarding antibiotic use has led to some confusion among cattle producers. Effective April 5, 2012, veterinarians can continue to prescribe extra-label drug use of any cephalosporin product as long as it is the same dosage, used through the same route of administration and in the same species as its FDA-approved label.

An earlier ruling was put on hold after concerns were raised by industry organizations. The new ruling will not drastically affect cattle producers who administer antibiotics prudently. The cephalosporin most used in beef cattle is Excede, and it will continue to be used metaphylactically and for treatments per label instructions. Extra-label use is also still permitted, as long as the dosage does not veer from the approved route of administration or species.

Follow the label. The Animal Medicinal Drug Use Clarification Act of 1994 made extra-label drug use an FDA-regulated veterinary medical activity, allowing veterinarians this option when the health of an animal is threatened, or when suffering or death may result from failure to treat an animal. Some drug classes have more stringent guidelines; extra-label use of fluoroquinolones, for example, is prohibited. Prohibitions may take the form of a general ban on the extra-label use of a drug or class of drugs or be limited to a specific species, dosage form, route of administration or combination of these factors.

To date, extra-label use of the following drugs is prohibited in food-producing animals: chloramphenicol; clenbuterol; diethylstilbestrol (DES); dimetridazole; fluoroquinolones; furazolidone; glycopeptides; ipronidazole and other nitroimidazoles; nitrofurazone; phenylbutazone in female dairy cattle 20 months of age or older; and sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine and sulfaethoxypyridazine).

As stewards of the industry, it is important that we continue to use antibiotics properly to improve the well-being of the animals we care for.