[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR530.20]

[Page 334]
 
                        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 C--Specific Provisions Relating to Extralabel Use of Animal and 
                  Human Drugs in Food-Producing Animals
 
Sec.  530.20   Conditions for permitted extralabel animal and human drug use in food-producing animals.


    (a) The following conditions must be met for a permitted extralabel 
use in food-producing animals of approved new animal and human drugs:
    (1) There is no approved new animal drug that is labeled for such 
use and that contains the same active ingredient which is in the 
required dosage form and concentration, except where a veterinarian 
finds, within the context of a valid veterinarian-client-patient 
relationship, that the approved new animal drug is clinically 
ineffective for its intended use.
    (2) Prior to prescribing or dispensing an approved new animal or 
human drug for an extralabel use in food animals, the veterinarian must:
    (i) Make a careful diagnosis and evaluation of the conditions for 
which the drug is to be used;-
    (ii) Establish a substantially extended withdrawal period prior to 
marketing of milk, meat, eggs, or other edible products supported by 
appropriate scientific information, if applicable;
    (iii) Institute procedures to assure that the identity of the 
treated animal or animals is carefully maintained; and
    (iv) Take appropriate measures to assure that assigned timeframes 
for withdrawal are met and no illegal drug residues occur in any food-
producing animal subjected to extralabel treatment.
    (b) The following additional conditions must be met for a permitted 
extralabel use of in food-producing animals an approved human drug, or 
of an animal drug approved only for use in animals not intended for 
human consumption:
    (1) Such use must be accomplished in accordance with an appropriate 
medical rationale; and
    (2) If scientific information on the human food safety aspect of the 
use of the drug in food-producing animals is not available, the 
veterinarian must take appropriate measures to assure that the animal 
and its food products will not enter the human food supply.
    (c) Extralabel use of an approved human drug in a food-producing 
animal is not permitted under this part if an animal drug approved for 
use in food-producing animals can be used in an extralabel manner for 
the particular use.