Page 116 - Microsoft Word -Cow Book 10-06-09 final update.doc

Extra Label Use:

Extra Label Use means actual use or intended use of a drug in animals in a
manner not in accordance with its approved labeling.

Only a veterinarian may use a drug in an extra-label manner. Such extra-label
use of drugs is provided for under the parameters described in FDA's Animal
Medicinal use Clarification Act (AMDUCA) regulations in 21 CFR part 530. The
AMDUCA allows veterinarians to prescribe FDA approved animal and human drugs
for extra label purposes in their treatment of animals. Certain restrictions do apply
such as no ELU in or on animal feed and certain drugs are prohibited from ELU in
food animals. (See section on Prohibited Drugs).

Under AMDUCA, veterinarians must label all drugs used for extra label purposes to
comply with the PMO drug labeling requirements.

Veterinarian-Client-Patient Relationship (VCPR), a major parameter for veteri-
nary extra-label use:

An appropriate VCPR must exist before a veterinarian prescribes a drug for an
extra-label use in food producing animals. A VCPR exists when:

1. the veterinarian has assumed the responsibility for making judgments regard-
ing the health of the animal(s) and the need for medical treatment, and the
client (owner or caretaker) has agreed to follow the instructions of the
veterinarian; and when,

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). This means that the veterinarian has recently seen and is
personally acquainted with the keeping and care of the animal(s) by virtue of
an examination of the animal(s), and/or by medically appropriate and timely
visits to the premises where the animals are kept; ........and when,

3. the practicing veterinarian is readily available for follow-up in case of adverse
reactions or failures of the regimen of therapy.

106