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| Reference > Miscellaneous > AMDUCA > Extralabel drug use algorithm |
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| 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? |
YES
Proceed with extralabel use of food animal drug. Establish extended withdrawal time. Ensure food safety. Maintain required records.* Label drug appropriately.** |
*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.
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**LABEL REQUIREMENTS
- Name and address of the prescribing veterinarian.
- Established name of the drug.
- Any specified directions 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.
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†Drugs Prohibited for Extralabel Use in Food Animals (Current as of June 2003. Check for updates on the FDA Web site at www.fda.gov/cvm)
- Chloramphenicol
- Clenbuterol
- Diethylstilbestrol (DES)
- Dimetridazole
- Ipronidazole
- Other Nitroimidazoles
- Furazolidone, Nitrofurazone, Other Nitrofurans
- Sulfonamide drugs in lactating dairy cows (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine)
- Fluoroquinolones
- Glycopeptides (example: vancomycin)
- 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 (Effective: June 20, 2006)
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American Veterinary Medical Association
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= AVMA/SAVMA Members Only