[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: 21CFR530.21]

[Page 336]
 
                        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. 530.21  Prohibitions for food-producing animals.

    (a) FDA may prohibit the extralabel use of an approved new animal or 
human drug or class of drugs in food-producing animals if FDA determines 
that:
    (1) An acceptable analytical method needs to be established and such 
method has not been established or cannot be established; or
    (2) The extralabel use of the drug or class of drugs presents a risk 
to the public health.
    (b) A prohibition may be a general ban on the extralabel use of the 
drug or class of drugs or may be limited to a specific species, 
indication, dosage form, route of administration, or combination of 
factors.