FDA may prohibit the extralabel use of an approved new animal or human drug or class of drugs in animals if FDA determines that:
- An acceptable analytical method for residue detection needs to be established and such method has not been established or cannot be established, or
- The extralabel use of the drug or class of drugs presents a risk to public health.
A prohibition may be a general ban on the extralabel use of the drug or class of drugs or may be limited to a specific species, indication, dosage form, route of administration, or combination of factors. To date, the ELDU of the following drugs has been prohibited in food-producing animals, regardless of whether or not the criteria for ELDU are met:
- Chloramphenicol;
- Clenbuterol;
- Diethylstilbestrol (DES);
- Dimetridazole;
- Ipronidazole;
- Other nitroimidazoles;
- Furazolidone;
- Nitrofurazone;
- Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfamethoxypyridazine);
- Fluoroquinolones;
- Glycopeptides;
- Phenylbutazone in female dairy cattle 20 months of age or older.
- Cephalosporin (excluding cephapirin) use in cattle, swine, chickens and turkeys:
-Using cephalosporin drugs at unapproved dose levels, frequencies, durations or routes of administration is prohibited
-Using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals);
-Using cephalosporin drugs for disease prevention
The following drugs, or classes of drugs, approved for treating or preventing influenza A in humans, are prohibited from ELDU in chickens, turkeys, and ducks regardless of whether or not ELDU criteria are met:
- Adamantanes;
- Neuraminidase inhibitors.
- Extralabel use of drugs in treating food-producing animals for improving rate of weight gain, feed efficiency, or other production purposes is prohibited under AMDUCA.
