[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: 21CFR530.22]

[Page 336-337]
 
                        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. 530.22  Safe levels and analytical methods for food-producing animals.

    (a) FDA may establish a safe level for extralabel use of an approved 
human drug or an approved new animal drug when the agency finds that 
there is a reasonable probability that an

[[Page 337]]

extralabel use may present a risk to the public health. FDA may:
    (1) Establish a finite safe level based on residue and metabolism 
information from available sources;
    (2) Establish a safe level based on the lowest level that can be 
measured by a practical analytical method; or
    (3) Establish a safe level based on other appropriate scientific, 
technical, or regulatory criteria.
    (b) FDA may require the development of an acceptable analytical 
method for the quantification of residues above any safe level 
established under this part. If FDA requires the development of such an 
acceptable analytical method, the agency will publish notice of that 
requirement in the Federal Register.
    (c) The extralabel use of an animal drug or human drug that results 
in residues exceeding a safe level established under this part is an 
unsafe use of such drug.
    (d) If the agency establishes a safe level for a particular species 
or category of animals and a tolerance or safe concentration is later 
established through an approval for that particular species or category 
of animals, for that species or category of animals, the safe level is 
superseded by the tolerance or safe concentration for that species or 
category of animals.