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Aquatic Veterinary Medicine
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Animal Medicinal Drug Use Clarification Act (AMDUCA)
Extralabel drug use algorithm
a drug labeled for food animals exist which fulfills all of the following?...
there a drug approved for food animals which could be used extralabelly?
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.***
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
Furazolidone, Nitrofurazone, other Nitrofurans
Glycopeptides (ex: vancomycin)
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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