[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: 21CFR530.11]

[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 B_Rules and Provisions for Extralabel Uses of Drugs in Animals
 
Sec. 530.11   Limitations.

    In addition to uses which do not comply with the provision set forth 
in Sec. 530.10, the following specific extralabel uses are not 
permitted and result in the drug being deemed unsafe within the meaning 
of section 512 of the act:
    (a) Extralabel use in an animal of an approved new animal drug or 
human drug by a lay person (except when under the supervision of a 
licensed veterinarian);
    (b) Extralabel use of an approved new animal drug or human drug in 
or on an animal feed;
    (c) Extralabel use resulting in any residue which may present a risk 
to the public health; and
    (d) Extralabel use resulting in any residue above an established 
safe level, safe concentration or tolerance.