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An
effective health plan should be a part of every feeder or
producer’s program. However, even the best preventive
program will not eliminate the need for at least occasional
individual treatments. It is here that a residue problem is
most likely to occur. Consult your veterinarian in
developing or changing treatment regimes to eliminate the
chance of residue occurrence.
In the
industry’s efforts to prevent violative drug residues, it is
essential to comply with label directions for administration
and withdrawal times. Any deviation from label directions
requires a veterinarian’s prescription and compliance with
additional precautionary steps discussed later in this
section. The
Withdrawal Time Chart sets forth a list of most FDA approved medications used for
individual treatments. This list is for reference only as
label directions can provide complete instructions that
should be followed when administering any drug. If you have
any questions regarding the use of specific drugs, consult
your veterinarian.
Use of a
medication other than in strict compliance with label
directions, including use in species or for indications not
listed on the label, or used at dosage levels higher than
those stated on the label and failure to observe the stated
withdrawal time is commonly referred to as "extra label drug
usage." It is in this area that you are most likely to
encounter violative drug residue problems. The Center for
Veterinary Medicine (CVM), a division of the FDA, has
revised its policies concerning extra label drug use. For
such usage, the CVM of the FDA specifies that the following
criteria must be met.
1. A
careful diagnosis is made by an attending veterinarian
within the context of a valid veterinarian-client-patient
relationship. (Section 9)
2. A
determination is made that: (a) there is no marketable drug
specifically labeled to treat the condition diagnosed, or
(b) treatment at the dosage recommended by the labeling was
found clinically ineffective.
3.
Procedures are instituted to assure that identity of the
treated animal is carefully maintained.
4. A
significantly extended period of time is assigned for drug
withdrawal prior to marketing of the treated animal, steps
are taken to assure the assigned time frames are met and no
harmful residue occurs.
The
issue of drug withdrawal for extra label drug use is unclear
at best. A veterinarian is the only one who can determine
the withdrawal time for a drug used extra label or across
species. These time periods must be based on the
veterinarian’s professional judgment of the drug action and
the conditions for which the drug is administered. Because
the role of the veterinarian is so critical in extra label
drug usage, the CVM has established guidelines to determine
when a veterinarian-client-patient relationship exists.
These criteria are:
1. The veterinarian has assumed the responsibility for
making clinical judgments regarding the health of the animal
and the need for medical treatment, and the client has
agreed to follow the veterinarian’s instructions.
2. The veterinarian has sufficient knowledge of the
animal to initiate at least a general or preliminary
diagnosis of the medical condition of the animal. This
means the veterinarian has seen and is personally acquainted
with the keeping and care of the animal by virtue of
examination of the animal or by medically appropriate and
timely visits to the premises where the animal is being
kept.
3. The veterinarian is readily available for follow up
evaluation in the event of adverse reactions or failure of a
treatment regimen.
The
veterinarian must make a professional judgment as to the
withdrawal time required for a drug used extra label. The
participant must maintain proper records to demonstrate that
the veterinarian’s prescription instructions have been
followed.
It is
only through proper records that you can hope to establish
liability with the proper party for a residue
contamination. The recordkeeping systems at the end of this
section were developed from systems that are working well
for many facilities. If you have a system that is working
for you and accomplishes the same results, there is no need
for change. However, if your system is not adequate, the
examples at the end of this section will provide ideas to
develop a system that will work for you.
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