Zoetis: Heritage Feeds Tomorrow. Pride. Commitment. Purpose. Values to carry you

Just a Reminder – No Extra-label use of Baytril® in Swine

October 12, 2010 — 

When the U.S. Food and Drug Administration (FDA) approved the use of enrofloxacin (Baytril®) in swine, the drug found itself in a somewhat unique position. While there are approved uses for the product in swine, the fluoroquinolones as a class are banned by the FDA for extra-label use. This is an important distinction, and one easily forgotten. There is no legal option to prescribe or use Baytril® in any extra-label manner in food-producing animals.

What this means is that it is only legal to use Baytril® in food-producing animals in the manner stated on the product label. The product may only be used at a single-injection dosage of 7.5mg/kg of body weight administered by subcutaneous injection behind the ear for the treatment and control of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis. Animals intended for human consumption must not be slaughtered within 5 days following injection.

The list of other drugs and drug classes banned from extra-label use can be found at 21 CFR Part 530.41. Currently, this list includes:

  1. Chloramphenicol;
  2. Clenbuterol;
  3. Diethylstilbestrol (DES);
  4. Dimetridazole;
  5. Ipronidazole;
  6. Other nitroimidazoles;
  7. Furazolidone;
  8. Nitrofurazone;
  9. Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine);
  10. Fluoroquinolones;
  11. Glycopeptides;
  12. Phenylbutazone in female dairy cattle 20 months of age or older;
  13. The following drugs, or classes of drugs, that are approved for treating or preventing influenza A, are prohibited from extralabel use in chickens, turkeys, and ducks:
    1. Adamantanes;
    2. Neuraminidase inhibitors.

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) governs the use of drugs in an extra-label manner in food-producing animals and defines the circumstances prohibiting such use. Remember, ultimately the veterinarian is legally responsible for the proper administration of products prescribed for use in food-producing animals.