The Food and Drug Administration is
announcing changes to the status of many
antimicrobials used in animal feed.
As of January 1, 2017, many antimicrobials that
previously were available to animal producers "over
the counter" will require an order from a
veterinarian before they can be fed, because
they'll become Veterinary Feed Directive drugs, or
VFD drugs.
This is one of the ways FDA is addressing the
issue of antimicrobial resistance.
The change is intended to reduce overuse and misuse
of antimicrobials, which could contribute to the
development of antimicrobial resistance,
a risk to human as well as animal health.
The change applies only to those antimicrobials that
are important in human medicine - medically
important antimicrobials.
Another change, also designed to limit overuse
or misuse of antimicrobials, is that
drug sponsors have voluntarily agreed, as of
2017, to remove the terms "growth promotion" or
"feed efficiency" - known as production claims -
from the labels of medically important
antimicrobials.
The use of these antimicrobials for these
production purposes will no longer be legal.
Medically important antimicrobials will still
be available for use in animal feed to treat
animals, but only under the VFD rule.
Under that rule, FDA will require that a
veterinarian be involved in making decisions about
when to use medically important antimicrobials.
As of January 1, 2017, animal producers must have
an order from a veterinarian to use these
antimicrobials in feed.
The VFD rule is not new, but FDA has modified it to
make it more workable to accommodate the changing
status of medically important antimicrobials
used in feed.
The VFD rule applies to drugs used in animal feed,
but the use of antimicrobial drugs in
water for animal production will also
require a veterinarian's authorization starting on
January 1, 2017.
These products will require a prescription to
authorize a medically important antimicrobial
for use in water for animals.
What is the VFD rule?
Simply, it's a rule that permits FDA to approve
animal drugs for use in or on feed, but only when
such use is ordered by a veterinarian.
All animal drugs for use in feed come as a Type A
medicated article, or Type B and Type C medicated
feed.
Type A medicated articles are not medicated feeds.
Instead, they are drug sources used to
manufacture medicated feeds.
Type B and Type C products are medicated feeds.
But only Type C medicated feeds can be given to
animals.
Type B medicated feeds are intermediate products used
to make Type C feeds.
Type C feeds can also be made from other Type C
medicated feeds.
Type B and Type C medicated feeds that
contain a VFD drug or a drug combination, are VFD
feeds.
So why can't a veterinarian simply
prescribe the use of a drug in feed?
Because state pharmacy laws would make the
process unworkable.
Those laws require a pharmacist to dispense
prescription drugs.
The pharmacist would have to travel to the feed
manufacturer each time the veterinarian prescribed
the addition of a drug to feed.
The VFD rule permits the veterinarian to order the
use of the VFD drugs and a VFD feed distributor to
supply the feed to the producer with no
involvement by a pharmacist.
Here's how the VFD regulation works: Before
you, the veterinarian, can lawfully authorize a use
of a VFD feed, you must be acting within the scope of
a veterinarian-client-patien
t-relationship, or VCPR.
If you decide a VFD feed is appropriate, you will
issue an order for its use - a VFD order.
The order must be in writing.
It cannot be given orally.
And you - and only you - must sign it, either by
signing a paper copy, or by providing an electronic
signature if you meet the requirements for using an
electronic signature.
The VFD rule specifies what information you need
to include on the order.
It's your responsibility as the veterinarian, to
ensure that the VFD order contains all of the
required information, and that the information about
the use of the drug is accurate and consistent
with the VFD drug's approval.
Many drug sponsors will create VFD order forms for
you to use.
But you can create your own, as long as it
contains all the information required by
the VFD rule.
Be sure to include a statement on the order
saying that the use of the feed containing a VFD drug
in a manner other than as directed on the labeling -
which would be considered extra-label use - is not
permitted.
Extra label drug use is defined in FDA regulations
as "actual or intended use of a drug in an animal in
a manner that is not in accordance with the
approved labeling."
To find out exactly what information is required on
the VFD order, go to the FDA Website, click on the
"Animal and Veterinary" navigational tab, and then
search for the Veterinary Feed Directive page.
There you can find brochures and other
material explaining what information must be
included on the order.
When you issue a VFD order, keep the original,
and give a copy of the order to your client - the
animal producer.
If the VFD is issued on paper, you can provide the
client with two copies: one for the client to keep
and one for the client to hand over to the VFD feed
distributor.
Or, you can provide one copy to the client and
send the other directly to the VFD feed distributor.
Your client can obtain the feed only after the
distributor has received the signed VFD order.
The veterinarian, the VFD feed distributor and the
livestock producer all must keep a copy of the
VFD order for at least 2 years from when it was
issued.
In this video, we wanted to provide you with only a
summary of the VFD rule.
The ultimate source of information required on
the VFD order is in the text of the rule, which
you can find in the Code of Federal Regulations,
Title 21, Part 558.6.
For additional information about the VFD rule, please
go to www.FDA.gov/SafeFeed.
We also have several other VFD videos posted there.
Thank you.