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U.S. Department of Health and Human Services

Animal & Veterinary

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Extralabel Drug Use – Clarification

FDA Veterinarian Newsletter July/August 2003 Volume XVIII, No 4

In answering a question regarding extralabel drug use in its “Ask CVM” section in the May/June issue of the FDA Veterinarian, the Center stated its position on extralabel use in a potentially confusing manner. The answer derived from a statement in the “FDA and the Veterinarian” booklet which is, unfortunately, also somewhat obscure.

It appears that CVM was trying to draw a distinction between preventive use in which a thoughtful decision is made by a veterinarian regarding the likelihood of harm to animals in the absence of prophylaxis and “preventive” use when such is not the case—calling the latter “routine prevention”. However, all aspects of extralabel use require the thoughtful determination of potential harm in the absence of treatment or control or prevention and, in that context, all of these uses are acceptable under the regulations. Therefore, there is no reason to single out preventive use in this regard and lump some ill-defined portion of it in with production claims as prohibited.

The phrase “routine prevention” will be removed from the “FDA and the Veterinarian” booklet at the next printing and readers are advised to discount it in the meantime.

We also note that the list of drugs prohibited from extralabel use that accompanied the answer discussed above failed to include some recent changes. The current list follows:

  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; and
  12. Phenylbutazone in female dairy cattle 20 months of age or older.