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e-CFR data is current as of March 5, 2021

Title 21Chapter ISubchapter EPart 530Subpart A → §530.3


Title 21: Food and Drugs
PART 530—EXTRALABEL DRUG USE IN ANIMALS
Subpart A—General Provisions


§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 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.

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