The following is a message from
FDA's Center for Veterinary Medicine
If you manufacture or mix feed, you play an
important role in food safety and animal health.
When manufactured properly, animal feed,
particularly medicated feed, will help protect
food safety and animal health.
And to properly make medicated feed, you need
to know and follow the rules.
What is a medicated feed?
Simply, it's any feed that has a drug in it.
Any time you mix a drug in feed, you are producing a
medicated feed.
Some feed mills making medicated feed are
required to have an FDA license, because they mix
drugs into feed that have a higher risk to human
health if residues of the drug end up in food
derived from animals.
But most feed mills do not need an FDA license.
Yours might not need one.
Regardless of whether you have a license or not, if
you mix medicated feed, you need to know that
there are rules you must follow.
And it doesn't matter if you run a business with
several manufacturing sites, or just a single
mill.
It doesn't matter if you mix medicated feed for
commercial sale, or simply for your own on-farm use.
If you manufacture or mix any form of medicated
animal feed, you need to know and follow the rules,
because they apply to you.
What are the rules?
One very important rule is the Current Good
Manufacturing Practice for Medicated Feeds, which is
often referred to as the GMP regulation.
The GMP regulation covers aspects of feed production
that are important for the production of safe
medicated feed.
The regulation has separate sections covering
these facility requirements: buildings
and grounds, equipment, and work areas and storage
areas.
The regulation also addresses product quality
assurance with sections on drug components,
laboratory assays, and equipment cleanout
procedures.
And it addresses labeling and records.
Accurate labeling is critical to making and
using feed safely.
The label must indicate whether the feed is
medicated; it must identify the drug and say
how much of it is in the feed; and the label must
state the intended purpose of the feed.
Labels also must present any warning and caution
statements for medicated feeds.
For example, feed containing Monensin must
carry a caution statement saying that it should not
be fed to horses.
It is toxic to horses and could kill them.
Having this information on the label should help
prevent this misuse of the cattle feed.
Another example of an important warning
statement, this one related to food safety, is
the statement giving the withdrawal period, often
expressed as a number of days, that a medication
must be taken away from the animal before that
animal can be slaughtered, or produce some other type
of human food product.
The withdrawal period prevents the presence of
unsafe drug residues in food.
While not all animal drugs have withdrawal periods,
many do, and it's important that you make
sure the withdrawal period is on the label to prevent
food safety problems.
So what does it mean to FDA that you are in
compliance with GMP rules?
The regulation is written to help ensure that the
medicated feed contains the right amount of the
drug.
This is important.
If the medicated feed has too little of the drug, it
might not work as it should.
If it has too much, it could create unsafe
residues of the drug in food produced from an
animal given that medicated feed.
This could create a food safety issue and a public
health threat.
Too much drug could also reduce animal performance
or even cause animal deaths.
We at FDA believe that medicated feed
manufactured according to GMPs should not raise
issues of safety to animals or people.
On the other hand, when you are not in compliance,
we could believe that you are not doing an
acceptable job of controlling your
operation.
That is, the facilities, equipment, operating
procedures, and records you are using may not be
adequate to ensure the medicated feed has the
identity, strength, and quality characteristics
needed for the drug.
In fact, if you're not following GMPs, we could
view your operation as lacking the control needed
to manufacture safe medicated feed, and
therefore, we could consider enforcement
action against the feed you produce or against
your operation.
Getting a copy of the GMP regulation is easy.
Look for the Code of Federal Regulations on the
Internet and go to Title 21, Section 225.
That's the current Good Manufacturing Practice for
medicated feeds.
The first section, applying to FDA-licensed
feed mills, is more comprehensive and detailed
than the second section, which applies to non-FDA
licensed mills.
And, if you want more information about how the
GMPs apply to your non-FDA-licensed feed
mill, go to our website, www.fda.gov
look under the Animal and
Veterinary tab, and search the guidance documents
area for Guidance for Industry number 72.
Feed manufacturers with FDA licenses are subject
to GMP inspections every two years.
Feed manufacturers that aren't required to have an
FDA license are not usually inspected as
frequently.
However, many state feed control offices conduct
regular GMP inspections of feed mills that are not
required to have a license from FDA, especially those
commercial feed mills that sell the medicated feed
they make.
Federal and state inspectors use the GMPs as
a tool to determine whether an operation is in
control.
You can use GMPs that way, too.
A valuable exercise for you is to conduct your own
self-inspection, to make sure your operation is in
compliance with the GMPs.
It will help you be sure that your products are
safe.
You have a key role in food and feed safety.
Your job is important.
Regardless of whether you need an FDA license to
manufacture medicated feed, you are required to
follow the medicated feed rules.
Read them.
Implement them.
They will help you make safe medicated feed, and
help keep food safe.
Thank you.