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| Reference > Miscellaneous > AMDUCA > Extralabel drug use algorithm |
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| Extralabel drug use algorithm |
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| No: There are few restrictions on extralabel use in non-food animals. Does an animal drug exist which fulfills all of the following?... |
NO
Proceed with extralabel use of an animal drug, if available. Maintain required records.* Label drug appropriately.** |
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*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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American Veterinary Medical Association
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