Subpart AGeneral Provisions
Sec. 530.1 Scope.
This part applies to the extralabel use in an animal of
any approved new animal drug or approved new human drug by
or on the lawful order of a licensed veterinarian within
the context of a valid veterinary-client-patient relationship.
Sec. 530.2 Purpose.
The purpose of this part is to establish conditions for extralabel
use or intended extralabel use in animals by or on the lawful
order of licensed veterinarians of Food and Drug Administration
approved new animal drugs and approved new human drugs. Such use
is limited to treatment modalities when the health of an animal is
threatened or suffering or death may result from failure to treat.
This section implements the Animal Medicinal Drug Use Clarification
Act of 1994 (the AMDUCA) (Pub. L. 103-396).
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
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 drugs 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
(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 drugs
(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
(i) A valid
veterinarian-client-patient relationship is one in which:
- 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;
- 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
- 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.
Sec. 530.4 Advertising and promotion.
Nothing in this part shall be construed as permitting the advertising or
promotion of extralabel uses in animals of approved new animal drugs or
approved human drugs.
Sec. 530.5 Veterinary records.
(a) As a condition of extralabel use permitted under this part, to permit
FDA to ascertain any extralabel use or intended extralabel use of drugs
that the agency has determined may present a risk to the public health,
veterinarians shall maintain the following records of extralabel uses.
Such records shall be legible, documented in an accurate and timely manner,
and be readily accessible to permit prompt retrieval of information. Such
records shall be adequate to substantiate the identification of the animals
and shall be maintained either as individual records or, in food animal
practices, on a group, herd, flock or per-client basis. Records shall be
adequate to provide the following information:
(b) A veterinarian shall keep all
required records for 2 years or as otherwise required by Federal or State
law, whichever is greater.
- The established name of the drug
and its active ingredient, or if formulated from more than one ingredient,
the established name of each ingredient;
- The condition treated;
- The species of the treated animal(s);
- The dosage administered;
- The duration of treatment;
- The numbers of animals treated; and
- The specified withdrawal, withholding
or discard time(s), if applicable, for meat, milk, eggs, or any food which
might be derived from any food animals treated.
(c) Any person who is in charge, control,
or custody of such records shall, upon request of a person designated by FDA,
permit such person designated by FDA to, at all reasonable times, have access
to, permit copying, and verify such records.