---
kind: "section"
citation: "21 C.F.R. § 530.12"
title: "21"
number: "530.12"
heading: "Labeling."
url: "https://uscodex.org/cfr/21/530.12"
---

# §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.

## Notes

### Authority

Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 379e.

### Source

Source: 61 FR 57743, Nov. 7, 1996, unless otherwise noted.