The Food and Drug Administration is
announcing changes to the use of many antimicrobial
drugs in animal feed.
Where you've previously been able to sell
medicated feed containing certain antimicrobials
over-the-counter to animal producers, beginning on
January 1, 2017, you will not be able to, unless the
producers have an order, called a veterinary feed
directive or VFD, from a licensed veterinarian for
that feed.
There are also additional requirements for
distributors of VFD feed.
These changes won't apply to all antimicrobials -
just those that are also used in human medicine.
These antimicrobials are known as medically
important antimicrobials.
Also, by the beginning of 2017, you'll see changes
to the labels of medically important antimicrobials
for use in feed.
Gone will be the statements that the
antimicrobial promotes growth or feed efficiency.
The drug sponsors, working with FDA, are voluntarily
removing those claims from the labels.
With those statements gone from the labels, the use
of the antimicrobials for those purposes will no
longer be legal.
Why these changes?
To address the issue of antimicrobial resistance.
Antimicrobial resistance means that bacteria
develop resistance to the antimicrobial drugs used
to fight them.
This is a serious health concern in both human and
veterinary medicine, and FDA has taken these steps
to help address this issue.
The change in the way medically important
antimicrobials are provided to animal
producers means the distribution and use of
these drugs will now be under the Veterinary Feed
Directive, or VFD, rule.
Implemented by FDA, this rule permits veterinarians
to authorize the use of certain drugs - drugs that
FDA's Center for Veterinary Medicine, or
CVM, has approved as VFD drugs - in or on animal
feed.
Beginning on January 1, 2017, medically important
antimicrobials will switch from their
over-the-counter status to VFD drug status.
The VFD rule specifies the roles and responsibilities
of the three parties involved in the process of
authorizing, distributing, and feeding VFD feeds -
the veterinarian, the VFD feed distributor, and the
animal producer client.
CVM believes it's important to involve
veterinarians in making decisions about the use of
antimicrobials.
They have the medical training necessary to
diagnose disease and identify the appropriate
antimicrobial for specific situations.
Their involvement is expected to ensure
judicious use of antimicrobials and help
reduce any misuse or overuse.
If you distribute VFD feeds, you are subject to
the VFD rule.
You are a VFD feed distributor if you
distribute a feed that contains a VFD drug to
another person, such as an animal producer, or even
to another distributor.
It makes no difference whether you manufacture
the VFD feeds you distribute, or you
distribute VFD feeds manufactured by someone
else.
If you're a VFD feed distributor, there are
some key points about VFD medicated feeds you need
to know.
First: Before filling your first VFD feed order, you
must send a one-time notification letter to
CVM, notifying the Center of your intent to
distribute VFD feeds.
The distributor notification needs to
include your complete business name and address,
your signature or the signature of your
authorized agent, and the date the notification was
signed.
You need to send the distributor notification
only once.
However, if there's a change in your business,
such as a change in the company's ownership or
their address, you need to send notification of that
change to CVM within 30 days after the change
occurs.
Second: You are not permitted to release a VFD
feed to an animal producer until you receive a lawful
VFD for the VFD feed, issued by a licensed
veterinarian.
A lawful VFD will include several pieces of
information, such as identification of the
veterinarian, the client, and the animals to receive
the VFD feed.
For more information about what's required on the
order, please go FDA's Safe Feed web page,
www.FDA.gov/safefeed <http://www.FDA.gov/safefe
ed>
requirements.
In some cases the animal producer can bring a copy
of the VFD to you.
In other cases, the veterinarian can send the
copy directly to you.
The VFD can be on paper, or it might be issued
electronically.
Either way, it must be completely filled out and
signed by the veterinarian.
The veterinarian can sign an order issued
electronically if the veterinarian can meet the
requirements for an electronic signature.
Note, you must receive a written VFD.
An order issued orally is not a lawful VFD.
Keep a copy of the VFD for 2 years from when it was
issued.
If you're shipping a VFD feed to another
distributor, you must first receive an
acknowledgment letter from that distributor.
This letter must indicate that the other distributor
has complied with the notification requirements;
that the distributor knows not to provide the VFD
feed to an animal producer without a VFD; and knows
not to ship the feed to another distributor
without receiving an acknowledgement letter.
You must keep the acknowledgement letter for
2 years from the date of the last shipment of feed.
VFD drugs come as Type A medicated articles.
Type A medicated articles are not medicated feeds.
Instead, they are drug sources used to
manufacture medicated feeds.
Type A medicated articles are then mixed into Type B
or Type C medicated feeds.
Only Type C medicated feeds can be fed to
animals.
Type B medicated feeds are intermediate products used
to make Type C medicated feeds.
Type C feeds can also be made from other Type C
medicated feeds.
Type B and Type C medicated feeds containing
a VFD drug, or a drug combination, are VFD
feeds.
All VFD drugs or feeds, regardless of whether they
are Type A, B, or C, must be correctly labeled.
Their labeling and advertising must include
this statement: "Caution: Federal law restricts
medicated feed containing this veterinary feed
directive drug to use by or on the order of a
licensed veterinarian." If you'd like to see more
information and other videos about VFD feeds,
please visit CVM's safe feed web page at
www.fda.gov/safefeed.
Thank you.