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![handle is hein.animal/fdavt0007 and id is 1 raw text is: I ~J ;J Fe ru r 1992JU fL.
MAR 9 1992 Jnuary/Feray19
n UMETS OFVol. VII, No.I
#FDfl J.94 R N RN
DISCU4glON OF EXTRA-LABEL DRUG USE
E xtra-label drug use has become an
issue of interest to many veterinar-
ians, food animal producers, and even
some consumer groups. The FDA
Veterinarian talked to Center Director,
Gerald B. Guest about the issue, and
asked him to explain why CVM con-
siders extra-label drug use to be an im-
portant topic for consideration.
FDA Vet: What does FDA mean by
the term extra-label drug use?
Dr. Guest Extra-label use occurs
when the user of an animal drug
product does not follow the directions
that are on the labeling of the drug.
This includes use in species or for indi-
cations (disease or other conditions)
not listed in the labeling, and use at
dosage levels higher than those stated
on the label.
FDA Vet Why is extra-label drug use
considered illegal?
Dr. Guest: Extra-label drug use is a
violation of the Food, Drug, and Cos-
metic Act [Section 512(a)(1)(B)]. I think
some individuals in the veterinary med-
ical community may be confused about
this aspect of the law. They may think
that since the Federal law does not
prohibit medical doctors (physicians)
from prescribing as they wish in hu-
mans, it must allow veterinarians to
use drugs as they wish in animals. This
is not the case. In fact, the law for
animal pharmaceuticals insists on strict
adherence to the label.
FDA Vet: Why does FDA have an
extra-label drug use policy?
Dr. Guest: The so-called extra-label
drug use policy is actually a Compli-
ance Policy Guide (CPG). CPGs are
used to provide guidance regarding
regulatory initiatives and enforcement
priorities to FDA field and headquarters
personnel. We recognize that a veteri-
narian, on occasion, will find the need
to use an approved animal drug in a
manner that does not appear on the
label. This use could occur when an
animal's health is immediately threat-
ened and suffering or death would
result from failure to provide effective
treatment. The Center developed this
compliance policy guide to assist in
defining enforcement priorities. A
primary objective of the policy is to as-
sure that the public health is protected.
The policy states that regulatory action
will not -ordinarily be considered
provided certain criteria are met and
precautions observed. These criteria in-
clude a careful medical diagnosis made
by the attending veterinarian within the
context of a valid veterinarian/cli-
ent/patient relationship. In addition, the
policy requires that no other specifically
labeled drug is marketed or available to
treat the disease condition or if there
is, the label dosage is not clinically ef-
fective in the animals to be treated. The
treated animals must be identified and
an extended drug withdrawal period or
milk discard period must be assigned.
(Continued, next page)
POLICY ON DISTRIBUTION
OF HUMAN DRUGS FOR
USE IN ANIMALS
In the July/August, 1991 issue of the
FDA Veterinarian (see page 6) we in-
cluded an article about human drugs
which are distributed to veterinarians
for treating animals. The article de-
scribed an FDA policy which had been
issued as Compliance Policy Guide
(CPG) 7125.35 in March, 1991. CVM
has received correspondence and tel-
ephone calls from veterinarians, phar-
macists, distributors, and others
regarding the policy, and it was dis-
cussed at CVM's Veterinary Medicine
Advisory Committee (VMAC) meeting
on October 31, 1991.
In the CPG, FDA stated that the
Agency is aware that human drugs are
being promoted and distributed by
manufacturers and or distributors for
use in animals, and that they are being
prescribed, dispensed, and adminis-
tered by veterinarians for animal use.
The Federal Food, Drug, and Cosmetic
Act (the Act) contains no provision for
use of human drugs for treating ani-
mals. However, CVM recognizes that
there are instances in which there sim-
ply are no approved animal drugs for
conditions in animals needing treat-
ment, particularly for companion ani-
mals, and human-labeled drugs are the
only reasonable alternative. Conse-
quently, the Agency recognizes that it
is not always reasonable to enforce the
law under every circumstance. The
(Continued, page 4)
In This Issue:
Antidote Availability Discussed . . . 3
New VMAC Chairman and
Committee Members ........ 5
1990 ADR Summary ........ 1-21
Codex Committee Meets ...... 8
U.S. DEPA
FOOD AND DRUG ADMINISTRATION
RTMENT OF HEALTH AND HUMAN
PUBLIC HEALTH SERVICE
SERVICES
CENTER FOR VETERINARY MEDICINE
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