[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: 21CFR530.3]

[Page 333-334]
 
                        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 A_General Provisions
 
Sec. 530.3  Definitions.

    (a) Extralabel use means actual use or intended use of a drug in an 
animal in a manner that is not in accordance with the approved labeling. 
This includes, but is not limited to, use in species not listed in the 
labeling, use for

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indications (disease or other conditions) not listed in the labeling, 
use at dosage levels, frequencies, or routes of administration other 
than those stated in the labeling, and deviation from the labeled 
withdrawal time based on these different uses.
    (b) FDA means the U.S. Food and Drug Administration.
    (c) The phrase a reasonable probability that a drug's use may 
present a risk to the public health means that FDA has reason to believe 
that use of a drug may be likely to cause a potential adverse event.
    (d) The phrase use of a drug may present a risk to the public health 
means that FDA has information that indicates that use of a drug may 
cause an adverse event.
    (e) The phrase use of a drug presents a risk to the public health 
means that FDA has evidence that demonstrates that the use of a drug has 
caused or likely will cause an adverse event.
    (f) A residue means any compound present in edible tissues that 
results from the use of a drug, and includes the drug, its metabolites, 
and any other substance formed in or on food because of the drug's use.
    (g) A safe level is a conservative estimate of a drug residue level 
in edible animal tissue derived from food safety data or other 
scientific information. Concentrations of residues in tissue below the 
safe level will not raise human food safety concerns. A safe level is 
not a safe concentration or a tolerance and does not indicate that an 
approval exists for the drug in that species or category of animal from 
which the food is derived.
    (h) Veterinarian means a person licensed by a State or Territory to 
practice veterinary medicine.
    (i) A valid veterinarian-client-patient relationship is one in 
which:
    (1) A veterinarian has assumed the responsibility for making medical 
judgments regarding the health of (an) animal(s) and the need for 
medical treatment, and the client (the owner of the animal or animals or 
other caretaker) has agreed to follow the instructions of the 
veterinarian;
    (2) There is sufficient knowledge of the animal(s) by the 
veterinarian to initiate at least a general or preliminary diagnosis of 
the medical condition of the animal(s); and
    (3) The practicing veterinarian is readily available for followup in 
case of adverse reactions or failure of the regimen of therapy. Such a 
relationship can exist only when the veterinarian has recently seen and 
is personally acquainted with the keeping and care of the animal(s) by 
virtue of examination of the animal(s), and/or by medically appropriate 
and timely visits to the premises where the animal(s) are kept.