[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR530.12]

[Page 335]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 530_EXTRALABEL DRUG USE IN ANIMALS--Table of Contents
 
 Subpart B_Rules and Provisions for Extralabel Uses of Drugs in Animals
 
Sec. 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.