Specific guidelines describe what should be included in the record, on the label, and how to maintain records involving ELDU. These are listed below:
Record Requirements:
- Identify the animals, either as individuals or a group;
- Species of animal(s) treated;
- Numbers of animals treated;
- Medical 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 products;
- Records must be kept for a minimum of 2 years after treatment;
- The FDA must be allowed 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 restricting use to a licensed veterinarian (“CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian”);
- Your specified withdrawal, withholding, or discard time for meat, milk, eggs, or any other food product originating from the treated animal(s).
