Beginning on January 1, 2017, the Food and Drug
Administration has new rules that will apply to
the use of certain antimicrobials in animal
feed.
Antimicrobials that are important for human
medicine, also known as medically important
antimicrobials, will be available for use in feed
only when authorized by a licensed veterinarian
under the Veterinary Feed Directive rule, or VFD
rule.
Medically important antimicrobials will no
longer be available "over the counter" for use in
feed.
The VFD rule permits FDA to approve animal drugs
that can be used in or on feed only when ordered by
a licensed veterinarian.
Animal drugs in this category are called VFD
drugs.
When VFD drugs are in or on feed, the feed is known
as VFD feed.
Another change as of January 1, 2017 is that
the labels of medically important antimicrobials
for use in animal feed will no longer include the
statement that these drugs can be used to promote
growth or increase feed efficiency.
The animal drug industry, in cooperation with FDA,
is voluntarily removing those claims from the
labels.
Why the changes?
To address the issue of antimicrobial resistance.
Bacteria develop resistance to the
antimicrobial drugs used to fight them.
That's what's meant by the term "antimicrobial
resistance".
It's not just an issue in human medicine.
It's an issue in veterinary medicine, too.
Antimicrobial resistance poses a threat to both
human and animal health.
And FDA has a responsibility to address
the risks to humans and to animals.
So here's how the VFD regulation works: Under
this regulation, FDA requires your veterinarian
to be engaged in a veterinarian-client-patien
t relationship - or VCPR - with you and with the
animals to be treated.
The VCPR is a set of requirements for the
working relationship the veterinarian has with the
client, who is the animals' owner or
caretaker, and it requires the veterinarian to have
sufficient knowledge of the animals to order, or
authorize, the treatment, control, or prevention of
disease in those animals.
The veterinarian will make a diagnosis of the disease
status of the specific group of animals and, if
it's appropriate, issue a veterinary feed directive,
or VFD, that authorizes use of an approved VFD
drug, or an approved combination VFD drug, in
feed for your animals.
The VFD rule requires several pieces of
information on the VFD, including identification
of the veterinarian; of you, the veterinarian's
client; the animals to be treated; the VFD drug to
be used; and directions for use of the VFD feed--
which includes the level of the drug in the VFD
feed and the length of treatment.
The VFD will also give the expiration date, which is
the last date the VFD feed covered by the order can
be fed.
If further treatment is required, ask your
veterinarian to assess the health of your animals and
the need for another VFD.
The VFD will include a statement saying that use
of the VFD feed "in a manner other than as
directed on the labeling" is not permitted.
Using the feed in ways not on the label is using the
feed in an "extra-label" fashion.
Examples of extra-label use for VFD feeds include
feeding animals for a period longer than
specified on the order, or feeding a VFD feed with a
VFD drug at a level different than what's
specified on the label.
The veterinarian may issue a VFD order on paper or
electronically.
If it's on paper, the veterinarian will give you
a copy, along with a second copy for you to
give to the VFD feed distributor.
Or, the veterinarian will give you a copy and send
another copy directly to the VFD feed distributor.
If the veterinarian issues and signs the VFD
electronically, you and your distributor will
receive a copy electronically.
You must keep a copy of the VFD order for at least
2 years from the date it was issued.
You can obtain the feed once the distributor has
received a copy of the VFD order.
In fact, the distributor cannot release a VFD feed
to you unless it has received a copy of the
signed VFD order from your veterinarian.
Some animal producers can obtain a VFD drug in the
form of a Type A medicated article, which is used to
manufacture a Type C medicated feed.
A VFD is not required for you to obtain the Type A
medicated article, but you will be required to have a
VFD order from your veterinarian prior to
feeding the VFD feed made with the Type A article to
your animals.
Feeding VFD feed without an order from a
veterinarian is unlawful.
In addition, you would be required to manufacture
the VFD feed in compliance with the VFD drug approval
as well as the medicated feed Current Good
Manufacturing Practice requirements.
If the VFD drug, Type A medicated article is
Category Two, then a VFD feed from such a drug can
be manufactured only at a licensed feed mill.
Licensed feed mills are required to manufacture
medicated feed in compliance with the
Current Good Manufacturing Practice requirements for
licensed feed mills.
If you'd like to see more information and other
videos about VFD feeds, please come to CVM's safe
feed web page at www.fda.gov/safefeed.
Thank you.