AVMA - Animal Medicial Drug Use Clarification Act (AMDUCA)

Extralabel drug use algorithm 

 

NOThere 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

* 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.