**120**

Guidance for Industry

Veterinary Feed Directive Regulation

This guidance is intended to notify pertinent federal/state employees
and members of the feed industry regarding the publication of the final
rule dealing with Veterinary Feed Directives.

Comments and suggestions regarding this guidance document should be
submitted to the Dockets Management Branch (HFV-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All
comments should be identified with the exact title of the document.

For general questions regarding this guidance document, contact Zoe Ann
Gill, Center for Veterinary Medicine (HFV-222), Food and Drug
Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6667;
email: <zgill@cvm.fda.gov>.

For scientific questions regarding this guidance document, contact Jo W.
Gulley, Center for Veterinary Medicine (HFV-226) Food and Drug
Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0170;
email: <jgulley@cvm.fda.gov>.

######### U.S. Department of Health and Human Services

######### Food and Drug Administration

**Center for Veterinary Medicine**

**March 1, 2001**

**What is a Veterinary Feed Directive?**

This final guidance represents our current thinking on this matter. It
does not create or confer any rights for or on any person and does not
operate to bind us or the public. An alternative approach may be used as
long as it satisfies the requirements of the applicable statute and
regulations.

A Veterinary Feed Directive (VFD) [Order]{.underline} refers to a
written authorization for use.

A Veterinary Feed Directive (VFD) [Drug]{.underline} refers to a new and
specific category of drugs.

# Background

Prior to 1996, FDA had only two options for regulating the distribution
of animal drugs: 1) over-the-counter (OTC), and 2) prescription. We
determined certain new animal drugs, vital to animal health, should be
approved for use in animal feed but only if these medicated feeds were
administered under a veterinarian's order and professional supervision.
For example, veterinarians are needed to control the use of certain
antimicrobials. Control is critical to reducing unnecessary use of such
drugs in animals and to slowing or preventing any potential for the
development of bacterial resistance to antimicrobial drugs. Safety
concerns relating to difficulty of diagnosis of disease conditions, high
toxicity, or other reasons may also dictate that the use of a medicated
feed is limited to use by order and under the supervision of a licensed
veterinarian. The VFD category will maintain public health protection
while allowing producers to obtain needed drugs efficiently and cost
effectively.

# Which drugs qualify as VFD drugs? 

When a new animal drug application is submitted to the Center for
Veterinary Medicine for approval, the appropriate division determines
whether a drug will be an OTC (over-the-counter), a prescription or a
VFD drug. A practicing veterinarian may not write a VFD order for an OTC
drug nor may he/she write a VFD order to be used contrary to the FDA
regulation for that drug. A veterinarian may only write a VFD order for
drugs approved for that category and only under the context of a valid
client-patient relationship (VCPR) as defined in Title 21, Code of
Federal Regulation 530.3(i).

# How many drugs have been approved under this category?

To date, only one drug has been approved under the category. The drug
Tilmicosin is approved as an antimicrobial for use in the control of
swine respiratory diseases.

# How does the veterinarian obtain a form for a VFD drug?

While it is not mandatory that the VFD drug sponsors provide copies of a
form for use by the veterinary profession, we believe the sponsors will
make the forms available in triplicate for the sake of efficiency and
completeness of the veterinarian's VFD order transmissions.
Nevertheless, we continue to give the veterinarian the option of
creating his/her own form for a VFD drug.

# 

# What specific information does the VFD form require?

-   Client's name, address and telephone and facsimile number;

-   Identification and number of animals to be treated/fed the medicated
    feed, including identification of the species of animals, and the
    location of the animals;

-   Date of treatment, and, if different, date of prescribing the VFD
    drug;

-   Approved indications for use;

-   Name of the animal drug;

-   Level of animal drug in the feed, and the amount of feed required to
    treat the animals;

-   Feeding instructions with the withdrawal time;

-   Any special instructions and cautionary statements necessary;

-   Expiration date of the VFD order;

-   Number of refills (reorders) if necessary and permitted by the
    approval;

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-   Veterinarian's license number and the name of the state issuing the
    license; and

-   The statement: "Extra-label use, (i.e., use of this VFD feed in a
    manner other than as provided for in the VFD drug approval) is
    strictly prohibited".

-   Any other information required by the VFD drug approval regulation.

# What is the responsibility of the feed distributor if the VFD form is not completely filled out? 

The feed distributor should not fill an order that does not have all
required information. The responsible veterinarian should be notified
that the order may not be filled until all the necessary information on
the VFD order is provided.

# Is there an alternate method by which a VFD order can be transmitted to the feed distributor?

We believe we must accommodate those situations where prompt hand
delivery of a VFD order is not possible, but immediate delivery of a VFD
feed is necessary. To accomplish this, transmission by facsimile or
other electronic means is permitted provided safeguards are in place to
prevent misuse. The industry must provide assurances these technologies,
as appropriate, are in compliance Title 21, Code of Federal Regulations,
Part 11. The distributor must receive an original signed VFD order
within 5 working days of receipt of the facsimile or electronic
document. Telephone orders are not allowed.

Who is held responsible, the veterinarian, the client (feeder) or feed
distributor if the actual VFD order is not properly distributed?

While all bear responsibility, the veterinarian is most in control.
Thus, we believe it is the veterinarian's obligation to assure that the
original VFD order is distributed to the feed distributor with the
timeliness required.

Is a feed mill or feeder permitted to distribute or feed an unapproved
drug product that is requested by a veterinarian in a VFD order?

A feed mill may not fill a VFD order and the client may not feed a VFD
feed to his/her animals that is in violation of FDA drug approval

What mechanisms are in place to discourage the producer from faxing the
order to multiple feed mills, thus abusing the drug?

While the possibility exists that a client may submit a copy of the VFD
order to several distributors to obtain additional VFD feed, the
distributor will become aware of the irregularity when the original VFD
order does not arrive within 5 days as required by the regulation.

Does the manufacturer of a medicated feed containing a VFD drug require
a feed mill license?

Yes. Classifying a drug as Category II adds additional regulatory
controls because feed manufacturing facilities must possess a medicated
feed mill license and be registered with FDA in order to manufacture a
Type B or Type C medicated feed from a Category II, Type A medicated
article. Registered feed mills are required to be inspected at least
every 2 years. Such inspections will help the agency ensure that VFD
requirements are met.

Explain the Distributor Notification Process.

All distributors must notify the Center for Veterinary Medicine of their
intent to distribute medicated feed containing a VFD drug. This is a
one-time only occurrence. Distributor, in this case, means any person
who distributes a medicated feed containing a VFD drug to another
distributor or to the client-recipient of the VFD. A distributor
notification must include the name, address (both physical and mailing,
if different) and be sent to: Center for Veterinary Medicine, HFV-226,
7500 Standish Place, Rockville, MD. 20855.

Under what circumstances would I be requested to submit an updated
notice to the FDA?

An updated notice is required within 30 days of any change in name or
business address.

# What is a notification letter and how is it different than an acknowledgement letter? 

A notification letter is a one-time notice by an individual or company
of its intent to distribute a medicated feed containing a VFD drug. An
acknowledgement letter is sent to the distributor by a purchaser, who is
not the ultimate user of the feed stating it will sell the VFD feed only
to a producer with a valid VFD order, or to another distributor who
provides a similar acknowledgment letter.

How does this regulation deal with refills, reorders or the length of
time a VFD order is valid?

We believe there are situations when refills and expiration dates,
possibly of several months, are appropriate to medicate multiple
production groups and provide efficient treatment of sick animals. We
further believe allowances of this type will vary considerably. Since we
cannot predict what types of drugs and disease situations will be
presented in the future, the issue of refills and reorders and the
duration of time a VFD order is valid will be considered on a
drug-by-drug basis as part of the new animal drug approval process.

If a VFD order is written for refills and the subsequent orders are
filled at a different establishment than the first, how do both
establishments retain the original order?

It is possible the VFD order may be required by one distributor first
and later by another for refill. The regulation requires that a feed
establishment retain the original copy of the order for two years,
thereby making it impossible to forward the original VFD order to
another establishment. In these situations, the client should contact
the issuing veterinarian and request a new supplemental VFD order.

## Veterinarian's Responsibility

-   Be appropriately licensed

-   Writes order for VFDs only under the context of a Valid Client
    Patient Relationship (VCPR) as defined in 21 CFR 530.3

-   Prepares and signs a written VFD order in triplicate providing all
    requested information

-   Provides the feed distributor with the original VFD order

-   Gives copy to producer

-   Retains copy for his/her records for a minimum of two years

-   Provides VFD orders for review and copying by FDA during inspection.

## Producer's Responsibility

-   Contacts the veterinarian to diagnose and treat the animals

-   Agrees to follow the veterinarian's recommendations

-   Administers the feed to the animals

-   Provides the original VFD order to the feed supplier if not
    previously done

-   Maintains copy of the VFD order a minimum of two years

-   Provides VFD orders for review and copying by FDA during inspection.

## Feed Mill/Distributor Responsibility

-   Retains original VFD order supplied by the veterinarian/producer for
    two years from date of issuance

-   Provides VFD order forms for review and copying by FDA during
    inspection

-   Files one-time notice with FDA of intent to distribute VFD drugs

-   Requires an acknowledgement letter from all consignees who
    distribute but are not the ultimate user of the feed

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-   Assures all labeling and advertising must prominently and
    conspicuously display the following cautionary statement:
    \`\`Caution: Federal law limits this drug to use under the
    professional supervision of a licensed veterinarian. Animal feed
    bearing or containing this veterinary feed directive drug shall be
    fed to animals only by or upon a lawful veterinary feed directive
    issued by a licensed veterinarian in the course of the
    veterinarian\'s professional practice.\'\'