Animal Medicinal Drug Use Clarification Act (AMDUCA)

Extralabel drug use algorithm

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Yes: Does a drug labeled for food animals exist which fulfills all of the following?...
No: Is there a drug approved for food animals which could be used extralabelly?
No: Is there a human drug or drug approved for non-food animals which could be used extralabelly?
No: If compounding of approved drugs will prevent animal pain and suffering, refer to FDA Compliance Policy Guide for compounding guidance.***
 
​YES
Proceed with extralabel use of human or non-food animal drug. Establish extended withdrawal time. Ensure food safety. Maintain required records.* Label drug appropriate.** ​ 
 
* and ** - See record and label requirements. 

* RECORD REQUIREMENTS

  • Identify the animals, either as individuals or a group.
  • Animal species treated.
  • Numbers of animals treated.
  • Conditions being treated.
  • The established name of the drug and active ingredient.
  • Dosage prescribed or used.
  • Duration of treatment.
  • Specified withdrawal, withholding, or discard time(s), if applicable, for meat, milk, eggs, or animal-derived food.
  • Keep records for 2 years.
  • FDA may have access to these records to estimate risk to public health. 

** LABEL REQUIREMENTS

  • Name and address of the prescribing veterinarian.
  • Established name of the drug.
  • Any specified direction for use including the class/species or identification of the animal or herd, flock, pen, lot, or other group; the dosage frequency, and route of administration; and the duration of therapy.
  • Any cautionary statements.
  • Your specified withdrawal, withholding, or discard time for meat, milk, eggs, or any other food.

​†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. 
  
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