|(a) Extra-label or off-label use is the actual or intended
use of a drug in an animal that is not in accordance with the approved
labeling, and includes, but is not limited to:
(1) compounded drugs;
(2) use in species not listed in the labeling;
(3) use for diseases or other conditions not listed
in the labeling;
(4) use at dosage levels, frequencies, or routes of
administration other than those stated in the labeling; and
(5) deviation from the labeled withdrawal time based
on these different uses.
(b) A veterinarian must use his or her discretion in
the off-label use of drugs for animals. In exercising such discretion,
a veterinarian shall consider, to the extent possible:
(1) whether the off-label use of a drug meets the community
standard of humane care and treatment set out in §573.22 of this
title (relating to Professional Standard of Care);
(2) the established safety of the off-label usage;
(3) the inclusion of a drug in a standard veterinary
(4) analyses of off-label usage in the veterinary medical
literature and in articles and commentaries written by the veterinarian's
peers in the veterinary medical profession;
(5) information provided by the drug's manufacturer,
vendor or the FDA as to whether off-label usage of a drug may present
a risk to public health; and
(6) any other sources of pertinent information.
(c) If anticipated off-label use of a drug is not commonly
accepted or used by average veterinarians in the community in which
the veterinarian practices or if the off-label usage does not have
an established safety record, the veterinarian shall orally or in
writing inform the client that the off-label usage is not commonly
accepted or used in the veterinary community and that such usage could
pose a risk to the health of the animal. Any oral notification shall
be recorded in the patient records.
(d) Extra-Label Drug Use in Food-Producing Animals.
(1) For animals intended for human consumption, a veterinarian
must establish an extended withdrawal interval sufficient to ensure
food safety. The withdrawal period must be supported by scientific
information, and the veterinarian shall note the method used to determine
the withdrawal interval in the patient records.
(2) A veterinarian shall not prescribe an extra-label
drug in a manner that will result in violative food residue, or any
residue that may present a risk to public health.
(3) Veterinarians shall ensure that procedures are
in place to maintain the identity of treated animals, and shall note
those procedures in the patient records.