1/5/2017 12:00:00 AM
A CATTLEMEN'S GUIDE TO THE VETERINARY FEED DIRECTIVE
about the use of antibiotics in the feed of food animals was first expressed
back in the 1960s. Since then there have been multiple reports and evaluations
by different groups around the world. Our use of antibiotics to prevent,
control, and treat bacterial disease in food animals is currently under great
scrutiny, with pressure to describe and reduce our use. In 2003, the FDA Center
for Veterinary Medicine began to require the evaluation of the microbial safety
of antibiotics that were being approved for food animals through their release
of Guidance for Industry (GFI) #152. This was followed by a second
document related to microbial safety, GFI # 159.
two documents set new standards for evaluating how antibiotic use in food
animals might have an effect on the ability to treat infectious disease in
people, and on the ability for a resistant bacteria to proliferate and cause
disease in our own intestinal tract.
2012, the FDA Center for veterinary medicine released another final document,
GFI #209. In this document the FDA asked for voluntary compliance with two
major changes in the way we use antibiotics in food animals. The first change
was that pharmaceutical companies would voluntarily remove growth promotion
claims for any medically important antibiotics used in the feed of food
animals. Secondly, they asked that all remaining uses of medically
important antibiotics in the feed or water of food animals be only under the
supervision of a licensed veterinarian. The veterinarian has been put in charge
of antibiotic stewardship for medically important antibiotics in food animals.
In feed, this takes the form of a veterinary feed directive. In water, this
takes the form of a prescription just as you would need to purchase a
prescription injectable product.
second document related to the requested label changes, GFI #13, was released
in 2013. This document is the roadmap for pharmaceutical companies to get to
where GFI #209 asked them to go. The pharmaceutical industry is complying with
these requests, with anticipated completion of all of the label changes by
is a page on the FDA CVM website where it is possible to see the progress of
all the listed labels which are affected by this change. Of the 283 affected
labels, some have been withdrawn by the sponsor and others are in the process
of being changed. The mechanism for rolling out the new labels later this year
has not been finalized as of this writing, but we may expect that we will have
sufficient time to understand the new labels and get a VFD in place for use in
food animals prior to January 1, 2017.
was some confusion when the final veterinary feed directive rule went into
effect October 1, 2015. The confusion came about when producers and
distributors heard that the final VFD rule had been passed and assumed that
this was now required for all medically important antibiotics. The requirement
for veterinary feed directive authorization for the remainder of the medically
important antibiotics used in food animals will begin when their final labels
take effect January 1, 2017. All of these drugs are also medically important
veterinary feed directive rule puts forth the regulations under which a
veterinarian may authorize, a distributor may distribute, and a producer may
use a feed requiring veterinary feed directive authorization. Currently there
are only three drugs which require a veterinary feed directive for their use.
These are all medically important antibiotics. They include the feed version of
tilmicosin (Micotil®) in both swine and cattle as well as the feed version of florfenicol
(Nuflor®) in fish.
Medically important means that this antibiotic, or another member of this
drug's class, is important for therapy of bacterial diseases in humans. This
list includes the following (with examples of antibiotics in this group with
uses in food or water in cattle).
(chlortetracycline, oxytetracycline, tetracycline)
* Sulfas (sulfamethazine, sulfadimethoxine)
* Macrolides (tylosin, tilmicosin)
* Aminoglycosides (neomycin)
are many other medically important groups used in food animals, such as the
cephalosporins (ceftiofur), the fluoroquinolones (enrofloxacin, danofloxacin),
and the phenicols (florfenicol), but they do not have feed or water labels for
use in cattle.
important antibiotics will require a veterinary feed directive for any label
use in feed, and will require a prescription for any use in water. A very
important point to understand is that any extra label use of a drug in the feed
for food animals is illegal. There is no gray area to this part of the
regulations. If it is not on the label, it cannot be used in that manner. This
includes duration of administration, dose, and indication for use. In contrast,
a veterinarian may prescribe extra label use of a medically important
antibiotic in the water if they have met the requirements of the Animal
Medicinal Drug Use Clarification Act (AMDUCA) regulations.
is also a group of antibiotics used in food animals which are classified as not
being medically important. These antibiotics will not require a veterinary feed
directive to be used in the feed of food animals. Examples of non-medically
important antibiotics, or other drugs not classified as antibiotics, used in
the feed of cattle are as follows.
(monensin, lasalocid, laidlomycin)
* Decoquinate (not an antibiotic)
* Amprolium (not an antibiotic)
is one exception: if non-medically important antibiotics are fed concurrently
with a medically important antibiotic, their concurrent feeding will have to be
authorized in the veterinary feed directive for the medically important
antibiotic. For example, monensin may be legally fed concurrently with the
medically important antibiotic tylosin. When fed by itself, monensin would not
require a VFD. When fed with tylosin, the VFD authorizing the use of tylosin
must authorize the concurrent feeding of monensin with tylosin.
can confirm that an antibiotic to be used in the feed of your animals requires
a VFD by looking for the following wording on the label. "Caution: Federal
law restricts medicated feed containing this veterinary feed directive drug to
use by or on the order of a licensed veterinarian."
you and your veterinarian agree that a medically important antibiotic is
appropriate to use in the feed of animals under your care, then your
veterinarian will provide you with a veterinary feed directive.
veterinary feed directive is a written (nonverbal) statement issued by a
licensed veterinarian in the course of the veterinarian's professional practice
that orders the use of a VFD drug or combination VFD drug in or on an animal
feed. The VFD rule is clear that this authorization must take place
within a valid veterinary-client-patient relationship, and that the
veterinarian must be licensed in the state where the animals receiving the VFD
feed are located.
A VFD may be either hard copy or electronic, but the regulations are clear that
the authorization cannot be only in verbal form. Your veterinarian will
keep the original copy and provide a copy to both you and the distributor of
the VFD drug. The veterinarian may choose to provide the VFD in either
electronic or hard copy form.
are some general requirements that are clearly defined in the VFD final rule.
The first is that animal feed bearing or containing a VFD drug or a combination
VFD drug (a VFD feed or combination VFD feed) may be fed to the animals only by
or upon a lawful VFD issued by a licensed veterinarian. Secondly, a VFD feed or
combination VFD feed must not be fed to animals after the expiration date on
the VFD. Third, use of feed containing this veterinary feed directive (VFD)
drug in a manner other than as directed on the labeling (extra label use) is
VFD final rule includes 15 specific informational inclusions in a VFD. The
expiration date is how long the authorization to feed the VFD feed is in
effect. This period may be stated on the label, or if the label is silent as to
the duration of the authorization, the veterinarian may authorize this use for
up to six months.
veterinarian will also specify the approximate number of animals to be fed the
VFD feed by the expiration date of the VFD, the duration over which the VFD
drug is to be fed, and the level of VFD drug in the VFD feed. Your veterinarian
has no other option than to adhere to the label in authorizing these uses.
are still some uncertainties as to specific details of the process, but
producers should not interpret this as meaning we will fail in our efforts to
institute this new system. The biggest thing producers can do today is to start
the conversation with their veterinarians about what medically important
antibiotics they are using in the feed or water. If a veterinarian doesn't
immediately come to mind, your first order of business is to establish a
relationship. Be prepared that this will be a discussion and not an automatic
authorization of your current practices.
Michael D Apley, DVM, PhD
Kansas State University