| Requirements for Use |
- ELDU is permitted only by or under the supervision of a veterinarian.
- ELDU is allowed only for FDA approved animal and human drugs.
- A valid Veterinarian/Client/Patient Relationship is a prerequisite for all ELDU.
- ELDU for therapeutic purposes only (animal’s health is suffering or threatened). Not drugs for production use.
- Rules apply to dosage form drugs and drugs administered in water. ELDU in feed is prohibited.
- ELDU is not permitted if it results in violative food residue, or any residue which may present a risk to public health.
- FDA prohibition of a specific ELDU precludes such use.
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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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