[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: 21CFR530.23]

[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 C--Specific Provisions Relating to Extralabel Use of Animal and 
                  Human Drugs in Food-Producing Animals
 
Sec.  530.23  Procedure for setting and announcing safe levels.

    (a) FDA may issue an order establishing a safe level for a residue 
of an extralabel use of an approved human drug or an approved animal 
drug. The agency will publish in the Federal Register a notice of the 
order. The notice will include:
    (1) A statement setting forth the agency's finding that there is a 
reasonable probability that extralabel use in animals of the human drug 
or animal drug may present a risk to the public health;
    (2) A statement of the basis for that finding; and
    (3) A request for public comments.
    (b) A current listing of those drugs for which a safe level for 
extralabel drug use in food-producing animals has been established, the 
specific safe levels, and the availability, if any, of a specific 
analytical method or methods for drug residue detection will be codified 
in Sec.  530.40.