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e-CFR data is current as of February 24, 2021

Title 21Chapter ISubchapter EPart 530Subpart B → §530.12


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.

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.

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