21 C.F.R. § 530.12 Labeling.
Title 21 - Food and Drugs
Any human or animal drug prescribed and dispensed for extralabel use by a veterinarian or dispensed by a pharmacist on the order of a veterinarian shall bear or be accompanied by labeling information adequate to assure the safe and proper use of the product. Such information shall include the following: (a) The name and address of the prescribing veterinarian. If the drug is dispensed by a pharmacy on the order of a veterinarian, the labeling shall include the name of the prescribing veterinarian and the name and address of the dispensing pharmacy, and may include the address of the prescribing veterinarian; (b) The established name of the drug or, if formulated from more than one active ingredient, the established name of each ingredient; (c) Any directions for use specified by the veterinarian, including the class/species or identification of the animal or herd, flock, pen, lot, or other group of animals being treated, in which the drug is intended to be used; the dosage, frequency, and route of administration; and the duration of therapy; (d) Any cautionary statements; and (e) The veterinarian's specified withdrawal, withholding, or discard time for meat, milk, eggs, or any other food which might be derived from the treated animal or animals.
Title 21: Food and Drugs
PART 530—EXTRALABEL DRUG USE IN ANIMALS
Subpart B—Rules and Provisions for Extralabel Uses of Drugs in Animals
§ 530.12 Labeling.
