AVMA - Animal Medicinal Drug Use Clarification Act (AMDUCA)

Extralabel drug use algorithm

Yes:Does a drug labeled for food animals exist which fulfills all of the following?...
No:Is there a drug approved for animals which could be used extralabelly?
No:Is there a human drug or drug approved for non-food animals which could be used extralabelly?
If compounding of approved drugs will prevent animal pain and suffering, refer to FDA Compliance Policy Guide for compounding guidance. ***

***Compounding of bulk drugs is illegal

†Drugs Prohibited for Extralabel Use in Food Animals (Current as of April 2012. Check for updates on the FDA Web site at www.fda.gov/cvm)

  • Chloramphenicol
  • Clenbuterol
  • Diethylstilbestrol (DES)
  • Dimetridazole
  • Fluoroquinolones
  • Furazolidone, Nitrofurazone, other Nitrofurans
  • Glycopeptides (ex: vancomycin)
  • Ipronidazole
  • Other Nitroimidazoles
  • Sulfonamide drugs in lactating dairy cows (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine).
  • Phenybutazone in female dairy cattle 20 months of age or older.
  • Adamantane and neuraminidase inhibitor classes of drugs that are approved for treating or preventing influenza A are prohibited therapy in chickens, turkeys, and ducks.
  • Cephalosporin (excluding cephapirin) in cattle, swine, chickens, or turkeys
    • Using cephalosporin drugs at unapproved dose levels, frequencies, durations or routes of administration is prohibited;
    • Using cephalosporin drugs in cattle, swine, chickens, or turnkeys 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.