[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: 21CFR530.25]

[Page 335-336]
 
                        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.  530.25  Orders prohibiting extralabel uses for drugs in food-producing animals.

    (a) FDA may issue an order prohibiting extralabel use of an approved 
new animal or human drug in food-producing animals if the agency finds, 
after providing an opportunity for public comment, that:
    (1) An acceptable analytical method required under Sec.  530.22 has 
not been developed, submitted, and found to be acceptable by FDA or that 
such method cannot be established; or
    (2) The extralabel use in animals presents a risk to the public 
health.-
    (b) After making a determination that the analytical method required 
under Sec.  530.22 has not been developed and submitted, or that such 
method cannot be established, or that an

[[Page 336]]

extralabel use in animals of a particular human drug or animal drug 
presents a risk to the public health, FDA will publish in the Federal 
Register, with a 90-day delayed effective date, an order of prohibition 
for an extralabel use of a drug in food-producing animals. Such order 
shall state that an acceptable analytical method required under Sec.  
530.22 has not been developed, submitted, and found to be acceptable by 
FDA; that such method cannot be established; or that the extralabel use 
in animals presents a risk to the public health; and shall:
    (1) Specify the nature and extent of the order of prohibition and 
the reasons for the prohibition;
    (2) Request public comments; and
    (3) Provide a period of not less than 60 days for comments.
    (c) The order of prohibition will become effective 90 days after 
date of publication of the order unless FDA publishes a notice in the 
Federal Register prior to that date, that revokes the order of 
prohibition, modifies it, or extends the period of public comment.
    (d) The agency may publish an order of prohibition with a shorter 
comment period and/or delayed effective date than specified in paragraph 
(b) of this section in exceptional circumstances (e.g., where there is 
immediate risk to the public health), provided that the order of 
prohibition states that the comment period and/or effective date have 
been abbreviated because there are exceptional circumstances, and the 
order of prohibition sets forth the agency's rationale for taking such 
action.
    (e) If FDA publishes a notice in the Federal Register modifying an 
order of prohibition, the agency will specify in the modified order of 
prohibition the nature and extent of the modified prohibition, the 
reasons for it, and the agency's response to any comments on the 
original order of prohibition.
    (f) A current listing of drugs prohibited for extralabel use in 
animals will be codified in Sec.  530.41.
    (g) After the submission of appropriate information (i.e., adequate 
data, an acceptable method, approval of a new animal drug application 
for the prohibited extralabel use, or information demonstrating that the 
prohibition was based on incorrect data), FDA may, by publication of an 
appropriate notice in the Federal Register, remove a drug from the list 
of human and animal drugs prohibited for extralabel use in animals, or 
may modify a prohibition.
    (h) FDA may prohibit extralabel use of a drug in food-producing 
animals without establishing a safe level.