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Extralabel drug use algorithm
 
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.**
Or
*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 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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