[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Rules and Regulations]
[Pages 31707-31735]
[FR Doc No: 2015-13393]

Vol. 80

Wednesday,

No. 106

June 3, 2015

Part III

Department of Health and Human Services

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 Food and Drug Administration

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21 CFR Parts 514 and 558

 Veterinary Feed Directive; Final Rule

Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 514 and 558

[Docket No. FDA-2010-N-0155]
RIN 0910-AG95

Veterinary Feed Directive

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its animal
drug regulations regarding veterinary feed directive (VFD) drugs. FDA's
current VFD regulation established requirements relating to the
distribution and use of VFD drugs and animal feeds containing such
drugs. This amendment is intended to improve the efficiency of FDA's
VFD program while protecting human and animal health.

DATES: This rule is effective October 1, 2015.

FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of Final Rule

    The purpose of this rulemaking is to revise FDA's VFD regulations
to improve the efficiency of the VFD program while continuing to
protect public health (human and animal health).
    In 1996, Congress enacted the Animal Drug Availability Act (ADAA)
(Pub. L. 104-250) to facilitate the approval and marketing of new
animal drugs and medicated feeds. In passing the ADAA, Congress created
a new regulatory category for certain animal drugs used in or on animal
food (animal feed) called veterinary feed directive drugs (or VFD
drugs). VFD drugs are new animal drugs intended for use in or on animal
feed which are limited to use under the professional supervision of a
licensed veterinarian. Any animal feed containing a VFD drug can only
be fed to animals based upon an order, called a veterinary feed
directive (VFD), issued by a licensed veterinarian in the course of the
veterinarian's professional practice. FDA published final regulations
implementing the VFD-related provisions of the ADAA in 2000 (see Sec.
558.6 (21 CFR 558.6)) (65 FR 76924, December 8, 2000). In the decade
since FDA published its VFD regulations, various stakeholders have
informed the Agency that the existing VFD process is overly burdensome.
In response to those concerns, FDA published several documents inviting
public input on ways to improve the VFD process, including an advance
notice of proposed rulemaking (ANPRM) (75 FR 15387, March 29, 2010)
(March 2010 ANPRM); draft regulatory text for proposed regulation (77
FR 22247, April 13, 2012) (April 2012 draft proposed regulation); and a
notice of proposed rulemaking (NPRM) (78 FR 75515, December 12, 2013)
(December 2013 NPRM).
    The VFD rule is the third of three core documents that FDA is using
to announce and implement its policy framework for the judicious use of
medically important antimicrobial drugs in food-producing animals. The
first document, Guidance for Industry (GFI) #209, entitled ``The
Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals,'' published April 2012, set forth FDA's framework
for instituting several key measures for ensuring the appropriate or
judicious use of medically important antimicrobial drugs in food-
producing animals. These measures include eliminating the feed and
water use of medically important antimicrobial drugs for production
purposes in food-producing animals and bringing all remaining
therapeutic uses under the oversight of licensed veterinarians. The
second document, GFI #213, entitled ``New Animal Drugs and New Animal
Drug Combination Products Administered in or on Medicated Feed or
Drinking Water of Food-Producing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use Conditions with GFI
#209,'' published December 2013, outlined a detailed process and
timeline for implementing the measures identified in GFI #209. Once GFI
#213 is fully implemented, affected feed-use antimicrobial drugs are
expected to transition from over-the-counter (OTC) to VFD marketing
status. Given that most of the products affected by this effort are
feed-use antimicrobial drugs this VFD regulation plays an important
role since it outlines the requirements associated with veterinary
authorization, distribution, and use of VFD drugs in animal feed.
    The VFD drug process as outlined in this final rule includes
important controls regarding the distribution and use of VFD drugs. In
addition to providing accountability, this final rule also updates the
VFD requirements to improve the efficiency of the process. These
regulatory enhancements are important for facilitating the transition
of a large number of OTC feed-use antimicrobial drugs to their new VFD
status.
    FDA intends to use a phased enforcement strategy for implementation
of this final rule as OTC drugs become VFD drugs under GFI #213. FDA
first intends to provide education and training for stakeholders
subject to this final rule such as veterinarians, clients (animal
producers), feed mill distributors and other distributors. Such
education and training efforts are important for supporting effective
implementation and compliance with the final rule. FDA will then engage
in risk-based general surveillance, as well as for-cause inspection
assignments. FDA intends to use information such as history of VFD use
and the volume of VFD feed being produced to focus inspectional
resources within the industry based on risk. FDA anticipates that it
will utilize various sources for obtaining such information including
such sources as FDA food and drug registration information, feed mill
licensing information, the VFD distributor notifications FDA receives,
and VFD distribution records maintained by drug sponsors and VFD
distributors.
    The provisions included in this final rule are based on stakeholder
input received in response to multiple opportunities for public
comment, including the March 2010 ANPRM, April 2012 draft proposed
regulation, and the December 2013 NPRM.

Summary of Major Provisions

    This final rule makes several important changes from the proposed
rule and several major changes to the current VFD regulations in part
558 (21 CFR part 558):
     The definition of ``Category II'' in part 558 is revised
to remove the automatic Category II designation for VFD drugs. Instead,
the categorization of VFD drugs will be determined on a case-by-case
basis based on the likelihood that the particular drug at issue will
produce an unsafe residue in edible products derived from treated
animals, as is currently the case for non-VFD feed use drugs.
     The definition of veterinary feed directive (VFD) drug is
revised to simply refer to the statutory definition to provide further
clarity.
     The proposed definition of combination veterinary feed
directive (VFD) drug is revised to reflect the

changes to the veterinary feed directive (VFD) drug definition.
     The proposed definition of a ``veterinary feed directive''
is revised to remove language that is duplicated in the
responsibilities of a veterinarian issuing a VFD.
     The proposed definition of the term ``distributor'' is
revised to use the word ``distributes'' instead of the word
``consigns'' as had been proposed.
     The regulatory text proposed for Sec.  558.6(a)(4) and
(b)(8) is revised to clarify that the veterinarian is required to keep
the original VFD (in hardcopy or electronically) and the distributor
and client must keep a copy of the VFD (in hardcopy or electronically).
     The current requirement that copies of the VFD and records
of the receipt and distribution of VFD feed must be kept for a period
of 2 years is retained instead of being changed to 1 year as was
proposed.
     The final rule provides that the veterinarian must issue
the VFD in the context of a valid veterinarian-client-patient
relationship (VCPR) as defined by the State requirements applicable to
where the veterinarian practices veterinary medicine. In States that
lack appropriate VCPR requirements applicable to VFDs, the veterinarian
must issue the VFD consistent with the Federally defined VCPR standard,
which is set forth in FDA's regulations at Sec.  530.3(i) (21 CFR
530.3(i)).
     The VFD expiration date requirement in the final rule
specifies that this is the date that authorization to feed the VFD feed
to animals expires. Animals must not be fed the VFD feed after the
expiration date of the VFD.
     The VFD requirement for approximate number of animals in
the final rule specifies how the approximate number of animals should
be determined.
     The final rule clarifies the affirmation of intent
statements to be used in VFDs issued by licensed veterinarians to
indicate whether a VFD drug may be used in conjunction with another
drug in an approved, conditionally approved, or indexed combination VFD
feed.
     The final rule clarifies the recordkeeping requirements to
differentiate what records are required to be kept for distributors who
manufacture VFD feed and those who do not manufacture the VFD feed.

Costs and Benefits

    The estimated one-time costs to industry from this final rule are
$1,411,000, most of which are simply costs to review the rule and
prepare a compliance plan. This equates to annualized costs of about
$201,000 at a 7 percent discount rate over 10 years. We estimate that
the government costs associated with reviewing the six VFD drug
labeling supplements that are expected to be submitted by the three
current VFD drug sponsors to be $1,900.
    The expected benefit of this final rule is a general improvement in
the efficiency of the VFD process. FDA estimates the annualized cost
savings associated with the more efficient requirements of the VFD
process to be $13,000 over 10 years at a 7 percent discount rate
(annualized at $11,000 over 10 years at a 3 percent discount rate).
Additionally, the reduction in veterinarian labor costs due to this
rule is expected to result in a cost savings of about $7.87 million
annually.

Table of Contents

I. Background
    A. History
    B. Judicious Use Policy for Medically Important Antimicrobials
II. Overview of the Final Rule
III. Comments on the Proposed Rule
    A. Definitions Section (Sec.  558.3)
    B. Veterinary Feed Directive Drugs (Sec.  558.6)
IV. Legal Authority
V. Final Regulatory Impact Analysis
VI. Paperwork Reduction Act of 1995
    A. Reporting Requirements
    B. Recordkeeping Requirements
    C. Third-Party Disclosure Requirements
VII. Environmental Impact
VIII. Federalism
IX. References

I. Background

A. History

    Before 1996, FDA had only two options for regulating the
distribution of animal drugs: (1) Over-the-counter (OTC) and (2) by
prescription (Rx). Drugs used in animal feeds were generally approved
as OTC drugs. Although the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) did not prohibit the approval of prescription drugs for use
in animal feed, such approvals would be impractical because many States
have laws that would require a feed mill to have a pharmacist onsite to
dispense prescription drugs. As additional animal drugs were developed,
FDA determined the existing regulatory options--OTC and Rx--did not
provide the needed safeguards or flexibility for these drugs to be
prescribed or administered through medicated feed. FDA believed that
these drugs, particularly certain antimicrobial drugs, should be
subject to greater control than provided by OTC status. FDA believed
this control would be critical to reducing unnecessary use of such
drugs in animals and to slowing or preventing the potential for the
development of bacterial resistance to antimicrobial drugs administered
through medicated feed.
    In 1996 Congress enacted the ADAA to facilitate the approval and
marketing of new animal drugs and medicated feeds. As part of the ADAA,
Congress recognized that certain new animal drugs intended for use in
animal feed should only be administered under a veterinarian's order
and professional supervision. Therefore, the ADAA created a new
category of products called veterinary feed directive drugs (or VFD
drugs).
    VFD drugs are new animal drugs intended for use in or on animal
feed, which are limited by an approved application, conditionally
approved application, or index listing to use under the professional
supervision of a licensed veterinarian. In order for animal feed
containing a VFD drug (VFD feed) to be fed to animals, a licensed
veterinarian must first issue an order, called a veterinary feed
directive (or VFD), providing for such use. In the Federal Register of
December 8, 2000 (65 FR 76924), FDA issued a final rule amending the
regulations in part 558 (21 CFR part 558) relating to new animal drugs
for use in animal feed to implement the VFD-related provisions of the
ADAA. In that final rule, FDA stated that because veterinarian
oversight is so important for assuring the safe and appropriate use of
certain new animal drugs, the Agency should approve such drugs for use
in animal feed only if these medicated feeds are administered under a
veterinarian's order and professional supervision. In addition, the
final rule noted that safety concerns relating to the difficulty of
disease diagnosis, drug toxicity, drug residues, antimicrobial
resistance, or other reasons may dictate that the use of a medicated
feed be limited to use by order and under the supervision of a licensed
veterinarian.
    It has been over a decade since FDA issued the final rule relating
to VFDs. Although currently there are only a few approved VFD drugs,
FDA has received comments from stakeholders characterizing the current
VFD process as being overly burdensome. In response to these concerns,
the Agency began exploring ways to improve the VFD program's
efficiency. To that end, FDA initiated the rulemaking process through
the publication of the March 2010 ANPRM. The March 2010 ANPRM requested
public comment on whether efficiency improvements are needed and, if
so, what specific revisions should be made to the VFD regulations.
Subsequent to this, FDA published the

April 2012 draft proposed regulation based on the considerable public
input it had received in response to the March 2010 ANPRM, and the
Agency requested comment on this draft language also.
    Recognizing that there would be challenges faced by animal
producers and veterinarians as FDA phases in veterinary oversight of
the therapeutic use of certain medically important antimicrobials, in
the spring of 2013, FDA and the U.S. Department of Agriculture's (USDA)
Animal and Plant Health Inspection Service jointly sponsored a series
of public meetings in various locations throughout the country (2013
public meetings). These meetings provided a forum to discuss potential
challenges faced by animal producers in areas that may lack access to
adequate veterinary services and to explore possible options for
minimizing adverse impacts.
    After considering the feedback received during the 2013 public
meetings, as well as comments received on our March 2010 ANPRM and
April 2012 draft proposed regulation, FDA published the December 2013
NPRM.

B. Judicious Use Policy for Medically Important Antimicrobials

    On April 13, 2012, FDA finalized a guidance document entitled ``The
Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals'' (GFI #209) (Ref. 1). This guidance document
represents the Agency's current thinking regarding antimicrobial drugs
that are medically important in human medicine and used in food-
producing animals. Specifically, GFI #209 discusses FDA's concerns
regarding the development of antimicrobial resistance in human and
animal bacterial pathogens when medically important antimicrobial drugs
are used in food-producing animals in an injudicious manner. In
addition, GFI #209 recommends two principles for assuring the
appropriate or judicious use of medically important antimicrobial drugs
in food-producing animals in order to help minimize antimicrobial
resistance development: (1) Limit medically important antimicrobial
drugs to uses in animals that are considered necessary for assuring
animal health and (2) limit medically important antimicrobial drugs to
uses in animals that include veterinary oversight or consultation.
    On December 13, 2013, FDA finalized a second guidance document, GFI
#213, entitled ``New Animal Drugs and New Animal Drug Combination
Products Administered in or on Medicated Feed or Drinking Water of
Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions with GFI #209'' (Ref. 2).
GFI #213 outlined a timeline and provided sponsors with specific
recommendations on how they could voluntarily modify the use conditions
of their medically important antimicrobial drug products administered
in feed or water to align with the two judicious use principles
announced in GFI #209. Once the use conditions of the affected products
are changed, these products can no longer be legally used for
production purposes, and can only be used for therapeutic purposes with
the supervision of a licensed veterinarian.
    Implementation of the judicious use principles set forth in GFI
#209, particularly the second principle recommending that affected
products be limited to uses in animals that include veterinarian
oversight or consultation, reinforces the need for FDA to reconsider
the current VFD program and how best to make the program more efficient
and less burdensome for stakeholders while maintaining adequate
protection for human and animal health. The majority of the
antimicrobial animal drug products that are the focus of GFI #209 and
GFI #213 are drugs approved for use in or on animal feed. All but a few
of these drugs are currently available OTC without veterinary oversight
or consultation and would be affected by the Agency's recommendation in
the guidances to switch these products' marketing status from OTC to
VFD. Therefore, it is important that the VFD process be as efficient as
possible when FDA's judicious use policy is fully implemented to
facilitate transition of these products from OTC to VFD marketing
status. In addition, an overly burdensome VFD process could disrupt the
movement of medicated feeds through commercial feed distribution
channels, thereby impacting the availability of medicated feed products
needed for addressing animal health issues.

II. Overview of the Final Rule

    This final rule amends FDA's regulations found in parts 514 and 558
(21 CFR parts 514 and 558) to change and clarify certain definitions
(Sec.  558.3 (21 CFR 558.3)), clarify the general requirements for VFD
drugs (Sec.  558.6(a) (21 CFR 558.6(a))), clarify the responsibilities
of the VFD drug sponsor (Sec.  514.1(b) (21 CFR 514.1(b)), and clarify
specific responsibilities of the veterinarian issuing the VFD (Sec.
558.6(b) (21 CFR 558.6(b))). Also, in this final rule we clarify the
specific responsibilities of any person who distributes an animal feed
containing a VFD drug (Sec.  558.6(c) (21 CFR 558.6(c))).
    In this rulemaking, the Agency finalizes many of the provisions in
the December 2013 NPRM. In addition, the final rule reflects revisions
the Agency made in response to comments on the December 2013 NPRM and
certain revisions made by the Agency on its own initiative after
considering all of the comments it received. Based on the changes to
the final rule from the proposed rule, the Agency has determined that
the effective date for the final rule should be 120 days after
publication.

III. Comments on the Proposed Rule

    This section summarizes comments FDA received in response to the
December 2013 NPRM and the Agency's response to those comments. FDA
received about 2,000 individual comments submitted to the docket on the
December 2013 NPRM. Some of the comments contained signatures by
multiple individuals or organizations. Comments were received from
veterinary, feed manufacturing, and animal production associations, as
well as consumer advocacy groups and individuals. Many of the comments
received from veterinarian, feed manufacturing, animal production
associations, and individuals generally supported the changes and
requested some additional changes or clarification on particular
issues. Many of the comments received from consumer advocacy groups and
individuals raised concerns over whether the changes would sufficiently
protect public health. FDA is making changes in the final rule to
address these concerns where the Agency has determined such changes to
be appropriate.
    The order of the discussion reflects the order in the regulatory
text and not the order of significance of a particular issue. To make
it easier to identify comments and FDA's responses, the word
``Comment,'' in parentheses, appears before the comment's description,
and the word ``Response,'' in parentheses, appears before FDA's
response. Each comment is numbered to help distinguish between
different comments. The number assigned to each comment is for
organizational purposes and does not signify the comment's value or
importance.
    In addition to the comments specific to this rulemaking that we
address in the following paragraphs, we received general comments
expressing views about public health, the use of antimicrobials,
antimicrobial resistance, antibiotic alternatives, animal husbandry
practices, meat consumption,

food labeling, genetically modified organisms, chemicals in food,
hormones in food, food (feed) additives, pesticides, fertilizers, trade
policy, inspection frequency, violation penalties, and Agency funding.
These comments express broad policy views and do not address specific
points related to this rulemaking. Therefore, these general comments do
not require a response.

A. Definitions Section (Sec.  558.3)

1. Category II Drug (Sec.  558.3(b)(1)(ii))
    The December 2013 NPRM proposed to remove VFD drugs from the
definition of Category II drugs. In this final rule, we are keeping our
proposed definition, which means that VFD drugs will no longer be
automatically designated as Category II drugs. Category I drugs will
remain defined as drugs that do not require a withdrawal period at the
lowest use level in each species for which they are approved. Category
II drugs will be defined as drugs that require a withdrawal period at
the lowest use level for at least one species for which they are
approved, or are regulated on a ``no-residue'' basis or with a zero
tolerance because of a carcinogenic concern, regardless of whether a
withdrawal period is required. As a result of this change, VFD drugs
will be designated as either Category I or II based on the definitions
in the final rule, including the existing VFD drug products that
previously were automatically designated as Category II drugs.
    (Comment 1) There were multiple comments supporting FDA's proposed
change to the definition of ``Category II'' drugs to discontinue the
automatic designation of VFD drugs as Category II drugs. These comments
supported Category I and II definitions that use a public health risk-
based approach to designate drugs based on the potential for unsafe
drug residues in edible tissues as reflected by drug withdrawal
periods. At least one comment also recognized that without this change,
farm animals may be unable to receive the treatment they need due to
supply chain disruptions. This comment noted that limiting the
manufacturing of VFD feed from Type A medicated articles to licensed
feed mills by automatically designating them as Category II would cause
a serious disruption in VFD feed availability and unnecessarily cause
harm to animals. The comment further noted that the proposed change to
remove the automatic designation should greatly reduce the supply chain
consequences.
    (Response 1) We agree that this approach provides a consistent
scientific rationale for designating VFD drugs as Category I or II and
will help prevent potential VFD feed supply chain concerns. Therefore,
in this final rule, we are keeping the definition proposed in the
December 2013 NPRM.
    The definitions proposed in the December 2013 NPRM designate drugs
as Category II if a withdrawal period is required at the lowest
approved use level for any species, or if the drug is regulated on a
``no-residue'' basis or with a zero tolerance because of a carcinogenic
concern regardless of whether a withdrawal period is required. The
category in which a new animal drug is placed determines whether the
Type A medicated article of that drug can be handled by a licensed or
unlicensed mill. Type A medicated articles are the most concentrated
form of the new animal drug and are used in the manufacture of another
Type A medicated article, or a Type B or C medicated feed. A Type B
medicated feed is intended solely for the manufacture of other Type B
or Type C medicated feeds and contains a substantial quantity of
nutrients with the new animal drug. A Type C medicated feed is intended
as the complete feed for the animal or may be added on top of a usual
ration, or offered as a supplement with other animal feed. A Type C
medicated feed has the lowest concentration of the new animal drug. In
order to reduce the potential to create unsafe drug residues, the
manufacturing of medicated feeds with Category II Type A medicated
articles is restricted to licensed feed mills. Licensed feed mills are
generally better suited technically to manufacture feeds containing
Category II drugs and are subject to more extensive good manufacturing
practice requirements than unlicensed feed mills.
    When the VFD regulations were implemented, FDA stated that
``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. . . . Registered feed mills
are required to be inspected at least every 2 years. Such inspections
will help the Agency to ensure that VFD requirements are met'' (65 FR
76924 at 76926). Since the regulations for VFD drugs were implemented
over a decade ago, FDA's experience has not shown a continued need to
ensure VFD requirements are met by automatically designating all VFD
drugs as Category II drugs. Since January 8, 2001, when the initial VFD
regulations became effective, FDA has only issued three warning letters
for violations related to noncompliance with the VFD regulations (Ref.
3). Furthermore, licensed feed mills are now required to be inspected
according to risk instead of at a set frequency. Drug categorization
determines whether a facility needs to be licensed to handle the drug
in the Type A form and is meant to provide additional regulatory
oversight for the manufacturing of the drug to minimize the potential
for drug residues to occur. In contrast, VFD designation is intended
primarily to provide for veterinary supervision of the use of medicated
feeds containing VFD drugs (VFD feeds). For VFD drugs that would
otherwise be categorized as Category I drugs (i.e., do not require a
withdrawal period at the lowest use level), FDA does not believe it is
necessary to limit the manufacture of VFD feeds to licensed feed mills.
Whether manufactured at a licensed or unlicensed feed mill, VFD feeds
can only be used when authorized by a lawful VFD issued by a
veterinarian.
    In addition, we agree this change will help prevent the potential
supply chain disruptions for VFD feeds that otherwise are likely to
occur once the Agency's policy regarding the judicious use of medically
important antimicrobial drugs in food-producing animals is fully
implemented. The existing definition of Category II drugs includes a
provision that says all VFD drugs are Category II drugs, regardless of
their potential to create unsafe drug residues. Thus, if FDA's policy
regarding the judicious use of medically important antimicrobials were
implemented with the definitions in the current regulations, drugs
currently designated as Category I drugs that transition from OTC to
VFD marketing status would automatically move from Category I to
Category II. FDA is concerned that this automatic designation would
cause supply chain disruptions for VFD feeds because the Type A
medicated articles would be restricted to use by licensed feed mills,
which number less than 1,000. Currently, since these drugs are OTC
Category I drugs, they are able to be used in the Type A form by
unlicensed feed mills, which number in the tens of thousands, including
farms that manufacture their own medicated feed for their own animals.
    For these reasons, FDA is revising the definition of Category II to
eliminate the automatic designation of VFD drugs into Category II. Once
those medically important antimicrobial drugs that are currently
marketed OTC are converted to VFD status as part of the implementation
of FDA's judicious use policy, they will be placed in Category

I or II based on whether they have a withdrawal period at the lowest
use level for at least 1 species in which they are approved or whether
they are regulated on a ``no residue'' basis or with a zero tolerance
because of carcinogenic concern, as defined in Sec.  558.3. As a
result, five of these medically important antimicrobial new animal
drugs are expected to remain in Category I; approximately three drugs
are expected to move from Category I into Category II. Each of these
drugs account for multiple drug product approvals, conditional
approvals, or index listings. Type A medicated articles for the drugs
that remain in Category I will continue to be available for use by the
unlicensed feed mills currently using these drugs as OTC drugs in
medicated feeds, thus reducing the potential for supply chain
disruption.
    (Comment 2) FDA also received multiple comments opposing the
proposed change to the definition of a ``Category II'' drug. Most of
these comments stated a concern about unlicensed feed mills handling
Type A medicated articles for drugs that are VFDs or antimicrobials.
The shared concern was that there would not be sufficient controls in
place, or oversight over unlicensed feed mills, to ensure that these
drugs are handled according to the requirements of the VFD regulation.
One comment was concerned that without requiring VFD drugs to first go
through a licensed feed mill, coupled with the proposed removal of the
explicit Federal VCPR requirement and the proposed change to the
definition of distributor, FDA would have no way to monitor the
majority of VFD drug use.
    (Response 2) At the time VFD regulations were initially issued in
December 2000, FDA was concerned that adherence to VFD regulations
would require additional regulatory oversight for the proper use of VFD
drugs in VFD feed. After over a decade of experience, FDA has only
issued three warning letters for compliance issues in the handling of
VFD drugs as Type A medicated articles by licensed feed mills, or as
Type B or C VFD feed by unlicensed feed mills (Ref. 3). Furthermore,
unlicensed feed mills routinely handle Category I Type A medicated
articles and are also required to adhere to current good manufacturing
practices (CGMPs). Although FDA may not inspect unlicensed feed mills
at the same frequency as licensed feed mills, they are inspected for
cause when surveillance tools, such as tissue residue or feed sampling,
determine that a problem has occurred (Ref. 4). State regulatory
Agencies also inspect licensed and unlicensed feed mills (Ref. 5).
Therefore, FDA does not believe VFD drugs require continued automatic
designation as Category II drugs.
    FDA recognizes that feed mill licensing is one method for FDA to
maintain an inventory of feed mills that handle and use Type A VFD
medicated articles; however, feed mill licensing is not the only way
for FDA to be aware of VFD drug use. Furthermore, with respect to the
concern raised in one of the comments that the change in the Category
II definition, taken together with other proposed changes would
diminish FDA's ability to monitor VFD use, the Agency is taking
measures to address that concern. First, FDA has reintroduced an
explicit VCPR requirement into the provisions for veterinarian
supervision and oversight in the regulatory text. Second, FDA has also
chosen not to proceed with the proposed changes to the definition of
distributor outlined in the December 2013 NPRM and has clarified
elsewhere in this document particular actions of on-farm processors
that make them distributors.
    FDA intends to use a phased enforcement strategy for implementation
of this final rule as OTC drugs become VFD drugs under GFI #213. FDA
first intends to provide education and training for stakeholders
subject to this final rule, such as veterinarians, clients (animal
producers), feed mill distributors and other distributors. These
education and training efforts are important for supporting effective
implementation and compliance with the final rule. As products change
to VFD status under the process outlined in GFI #213, FDA will engage
in general surveillance, as well as for-cause inspection assignments.
These assignments will be risk-based and in response to adverse
observations. In order to engage in a risk-based work planning
approach, FDA intends to gather information, such as VFD use and the
volume of VFD feed being produced within the industry. This information
would be gathered through multiple sources, such as FDA food and drug
registration information, feed mill licensing information, the VFD
distributor notifications FDA receives, and VFD distribution records
maintained by drug sponsors and VFD distributors. This information will
allow FDA to focus inspectional resources within the industry based on
risk.
    Therefore, FDA is removing VFD drugs from the definition of
Category II drugs. Instead of automatic Category II designation, VFD
drugs will now be categorized according to the risk of drug residues
based on whether they have a withdrawal period at the lowest level use
in any species for which they are approved, or whether they are
regulated on a ``no residue'' basis or with a zero tolerance because of
carcinogenic concern. This includes the existing approved VFD drug
products, each of which will either remain in Category II or be
redesignated as Category I drugs based on whether they meet the
definition of Category I or the revised definition of Category II.
2. Veterinary Feed Directive Drug (Sec.  558.3(b)(6))
    In the December 2013 NPRM, we proposed changes to better align the
definition of ``veterinary feed directive (VFD) drug'' in FDA's
regulations with the statutory definition in section 504 of the FD&C
Act (21 U.S.C. 354) and to provide additional clarity. We did not
receive comments specifically related to our proposed change in
definition. However, upon further review we are providing more clarity
to the VFD drug definition in this final rule by using the statutory
definition in the FD&C Act. That definition of a ``veterinary feed
directive (VFD) drug'' states that it is ``[a] drug intended for use in
or on animal feed which is limited by an approved application filed
pursuant to section 512(b), a conditionally-approved application filed
pursuant to section 571, or an index listing pursuant to section 572 to
use under the professional supervision of a licensed veterinarian. . .
.'' This change in Sec.  558.3(b)(6) provides consistency between the
statute and the regulation and helps to reduce the potential for
confusion.
3. Veterinary Feed Directive (Sec.  558.3(b)(7))
    FDA did not receive specific comments regarding the addition of
language in the proposed VFD definition in Sec.  558.3(b)(7) stating
that a VFD may be issued in hardcopy or through electronic means.
However, upon further review, we are removing this duplicative language
because similar language appears in Sec.  558.6(b) concerning the
responsibilities of the veterinarian issuing the VFD. Section 558.6(b)
provides more clarity by specifying that a fax also can be used. This
change avoids duplication in the regulatory text and helps to reduce
potential reader confusion about whether transmitting a VFD by fax is
allowed.
    Also to help reduce the potential for confusion, FDA is removing
the duplicative language concerning the oversight and supervision
requirements

for issuing a VFD from the definition of a veterinary feed directive
(Sec.  558.3(b)(7)) and from the general requirements related to
veterinary feed directive drugs (Sec.  558.6(a)(1)), because the same
requirements are also in the provision (Sec.  558.6(b)) that discusses
the responsibilities of the veterinarian issuing the VFD. FDA received
many comments concerning the oversight and supervision requirements for
veterinarians issuing a VFD, which are addressed in the discussion of
the responsibilities of the veterinarian issuing the VFD (558.6(b)).
This change eliminates duplication in the regulatory text and clarifies
that the requirement for oversight and supervision is the
responsibility of the veterinarian.
4. Distributor (Sec.  558.3(b)(9))
    In the December 2013 NPRM, we proposed to change the definition of
``distributor.'' In particular, we proposed to change the phrase ``any
person who distributes a medicated feed containing a VFD drug to
another person'' to ``any person who consigns a medicated feed
containing a VFD drug to another person.'' Many of the comments we
received expressed concern that this definitional change was meant to
narrow the scope of who is defined as a distributor.
    (Comment 3) Some comments requested that we maintain the current
definition that a distributor is any person who distributes a medicated
feed containing a VFD drug to another distributor or to the client-
recipient of the VFD. These comments were concerned that use of the
term ``consigns'' instead of ``distributes'' in the proposed definition
would exempt operations that were previously considered to be
distributors. Some of these comments thought that the proposed changes
would narrow the scope of the definition such that it would exclude
from the distributor notification requirements the majority of
facilities where medicated feeds are mixed. One comment supported the
definition of distributor proposed in the December 2013 NPRM.
    (Response 3) We used the term ``consigns'' in place of the term
``distributes'' with the intent to provide additional clarity; however,
the comments we received indicated this proposed terminology was more
confusing. In addition, many comments perceived this change as an
attempt to narrow the definition of distributor. As stated in the
December 2013 NPRM, our intent was to improve the clarity of this
definition, not to narrow the scope. As a result of the comments
received and the discussions that occurred at public meetings about
this proposed change, we are retaining the existing term
``distributes'' as part of the definition of distributor.
    In the December 2013 NPRM, we noted that ``on-farm mixers that only
manufacture medicated feeds for use in their own animals are not
distributors.'' Based on the comments, we would like to provide
additional clarity. Some comments perceived this statement to exempt
all on-farm mixers from requirements that apply to distributors.
However, this statement was intended to describe a limited and specific
situation in which FDA does not intend to consider on-farm mixers to be
distributors. By on-farm mixers, we were specifically referring to any
person who is mixing VFD feed on a ``farm'' as that term is defined in
21 CFR 1.227, who is only feeding that VFD feed to their own animals on
that farm. In addition, the on-farm mixer must only be manufacturing
VFD feed for their use in their own animals on their own farm (e.g.,
animal production facility), meaning that the ownership of the feed
mill, the animals, and the animal production facility must be the same
and the on-farm mixer must be the person using the VFD feed. In
contrast, for example, when Person A mixes VFD feed on their farm for
their own animals, but also mixes feed and distributes it to Person B's
farm, Person A is acting as a ``distributor'' as that term is defined
in Sec.  558.3 and, therefore, will be required to comply with the
distributor requirements. Another example is when Person C operates a
feed mill and owns animals, but distributes the feed to Person D who
raises Person C's animals on Person D's farm (e.g., a contract grower),
that person (Person C) who operates the feed mill would also be a
distributor under the definition.
    (Comment 4) Some comments requested that all facilities that
dispense feed to an animal production facility be required to submit a
notification to FDA. One comment suggested we define a distributor as
``any person who consigns a medicated feed containing a VFD drug to
another distributor or to an animal production facility.''
    (Response 4) FDA does not believe it is necessary to require that
all persons who dispense VFD feed to an animal production facility
submit a notification to FDA. For example, if a person purchases a Type
B VFD feed and then mixes it on their farm into a Type C VFD feed and
feeds it to their own animals on their farm in accordance with a lawful
VFD, they are dispensing VFD feed to an animal production facility
because the mixing operations are not part of the animal production
facility. However, they are not acting as a ``distributor'' as that
term is defined in Sec.  558.3 because they are not distributing to
another person. When a person who dispenses VFD feed to an animal
production facility obtains the VFD feed from a distributor, they are
required to submit a VFD or acknowledgment letter to the distributor
from whom they obtained the VFD feed. This documentation allows FDA to
identify users of VFD feed from the distributor's records for purposes
of surveillance, inspection, or investigation. In addition, should a
person who dispenses VFD feed to an animal production facility obtain a
VFD Type A medicated article for manufacture of the VFD feed, the
sponsor of the VFD Type A medicated article is required to maintain a
record of distribution.
    (Comment 5) One comment was concerned that the required one-time
notification to FDA that someone is a distributor of VFD feeds could
discourage distribution and sale of floor stock.
    (Response 5) The requirement for a person distributing VFD feed to
notify FDA when they first engage in such distribution is a statutory
requirement. (See section 504(a)(3)(C) of the FD&C Act.) We understand
that some businesses may choose not to engage in the sale of floor
stock. However, in order to adequately protect public and animal
health, FDA must be able to track the distribution of VFD feed, and
one-time notification to FDA upon first engaging in the distribution of
a VFD feed provides the minimum information needed for this tracking.
We do not agree that the minimal burden of a one-time notification to
FDA would be a significant factor in discouraging the distribution of
floor stock. Furthermore, FDA believes there is no compelling reason to
treat distributors who only sell floor stock differently from
distributors who distribute VFD feed through other sales models.
    (Comment 6) One comment requested clarification on whether a
manufacturer of a Type B VFD feed who distributes the Type B VFD feed
to an animal producer who then makes a Type C VFD feed needs to get an
acknowledgement letter from the animal producer as opposed to a VFD.
    (Response 6) When a manufacturer of a Type B VFD feed distributes
the Type B VFD feed to an animal producer, the animal producer may
manufacture a Type C VFD feed to either feed the VFD feed to his or her
own animals and/or further distribute the Type C VFD feed to another
distributor or client-recipient. If the Type B VFD feed is being
shipped to an animal producer who is not a

distributor, the animal producer must provide a VFD for the receipt of
the Type B VFD feed from the distributor. If the Type B VFD feed is
being shipped to an animal producer who is a distributor that has sent
a one-time notification to FDA, the animal producer must supply either
an acknowledgment letter or a VFD for the receipt of the Type B VFD
feed from the distributor. (Note: In order for the animal producer to
receive a Type B or Type C VFD feed without a VFD in hand, he or she
must have previously notified FDA that he or she is a distributor.) If
the animal producer provides an acknowledgment letter to the
distributor from whom the animal producer receives the VFD feed, the
animal producer must either receive an acknowledgment letter or a VFD
prior to further distributing the VFD feed to another person, or have a
VFD on hand prior to feeding the Type C VFD feed to his or her own
animals. We have revised the definition of acknowledgment letter in
(Sec.  558.3(b)(11)) to clarify that when an animal producer is acting
as a distributor as defined in (Sec.  558.3(b)(9)), they may provide an
acknowledgment letter even if they are the ultimate user of some of the
VFD feed.
5. Animal Production Facility (Sec.  558.3(b)(10))
    The December 2013 NPRM did not propose a change to the definition
of animal production facility. However, we received comment on the
definition.
    (Comment 7) A few comments requested that FDA define ``animal
production facility'' more broadly to include the location where the
medicated feed is made. These comments cited a concern that movement of
VFD feed would be limited by this definition because shipment of VFD
feed to an animal production facility must frequently go beyond the
gate to a facility or feed mill where the animals are not housed.
    (Response 7) The term animal production facility is defined as ``a
location where animals are raised for any purpose, but does not include
the specific location where medicated feed is made.'' (Sec.
558.3(b)(10)). The definition of animal production facility does not
hinder the movement of feed between a feed mill and an animal
production facility. VFD feed may be shipped from a distributor
directly to an animal production facility, or may first be delivered to
a facility or feed mill that is located where the animals are not
housed. Provided the recipient of such feed has a lawful VFD and is the
owner of both the facility or feed mill to which the feed was delivered
and the animal production facility, further movement of that VFD feed
to the actual animal production facility would not be limited and we
would not consider such further movement to be the activity of a
``distributor.''
6. Combination VFD Drug (Sec.  558.3(b)(12))
    In the December 2013 NPRM, we added a definition for the term
``combination veterinary feed directive (VFD) drug.'' In the final
rule, we have further clarified that definition to align the language
with the statutory definition of a veterinary feed directive drug.

B. Veterinary Feed Directive Drugs (Sec.  558.6)

1. General Requirements Related to VFD Drugs (Sec.  558.6(a))
a. VFD Retention and Transmission Requirements (Sec.  558.6(a)(4))
    In the December 2013 NPRM, we proposed that VFDs would no longer be
specifically required to be produced in triplicate; however, all three
involved parties (veterinarian, distributor, and client) still would be
required to receive and keep a copy of the VFD, either electronically
or in hardcopy. If the VFD is transmitted electronically, the
veterinarian would no longer be required to send the original in
hardcopy to the distributor.
    (Comment 8) Many comments supported these changes. Some comments
indicated that there was some confusion about whether an electronic
copy of the VFD would satisfy the recordkeeping requirement.
    (Response 8) To improve the clarity of this section, we have
revised the regulatory text to more precisely indicate the
recordkeeping requirements. An electronic copy of the VFD is sufficient
for recordkeeping purposes. The original no longer needs to be sent to
the distributor. As we stated in the December 2013 NPRM, this hardcopy
requirement has become outdated by modern electronic communication and
presents an unnecessary burden on the industry.
    This revision further reduces the number of paper copies requiring
physical recordkeeping space. The December NPRM, however, did not
specify who should maintain the original. Because of the confusion
indicated in the comments, we are revising the rule to specify that the
original should be maintained by the veterinarian who issued the VFD
and should be maintained in the manner it was generated, either
electronic or hardcopy. The client and distributor should each also
have a copy of the VFD, and that copy may be electronic or hardcopy.
    (Comment 9) A few comments addressed the regulatory requirements
for electronically generated documents. One comment asked what
requirements would apply to records with an electronic signature.
Another comment urged FDA to not require compliance with 21 CFR part 11
(part 11) for VFDs transmitted and stored electronically.
    (Response 9) The regulations in part 11 (Electronic Records;
Electronic Signatures) describe FDA's standards for assessing whether
electronic records and electronic signatures are trustworthy and
reliable and generally equivalent to paper records with handwritten
signatures. Electronic records, such as an electronic VFD that meets
the requirements of part 11, may be used in lieu of a paper VFD (i.e.,
VFDs that are generated and signed on paper). As we have previously
stated in GFI #120: Veterinary Feed Directive Regulation Questions and
Answers, published on March 26, 2009, part 11 applies to records in
electronic form that are created, modified, maintained, archived,
retrieved, or transmitted, under any FDA records requirements.
Therefore, electronic VFDs issued by veterinarians must be compliant
with part 11, and VFDs received and electronically stored by
distributors and clients must be compliant with part 11. Part 11 does
not apply to paper records that are, or have been, transmitted by
electronic means (such as facsimile, email attachments, etc.). Part 11
requires a one-time certification that the electronic signatures in
their system, used after August 20, 1997, are intended to be the
legally binding equivalent of the signer's handwritten signature (Ref.
6). Additional information about part 11 compliance, including
information on how FDA intends to exercise enforcement discretion with
regard to certain part 11 requirements during the reexamination of part
11, can be found in GFI Part 11, Electronic Records; Electronic
Signatures--Scope and Application (Ref. 7).
    (Comment 10) One comment suggested that a paper VFD process would
be unwieldy, costly, and burdensome.
    (Response 10) There are relative advantages and disadvantages to
generating and keeping records in either electronic or paper form. We
believe that businesses should be able to decide what format
(electronic or hard copy) they would like to use to fulfill the
recordkeeping requirements. For that reason, we proposed regulations
that removed the explicit requirement that

VFDs be issued in triplicate and that the original VFD be transferred
from the veterinarian (either directly or through the client) to the
distributor. The final regulatory text allows businesses to decide,
based on their unique business structure and operation, which
recordkeeping format (electronic or paper) to use to fulfill the VFD
recordkeeping requirements.
b. Caution Statement on Labeling (Sec.  558.6(a)(6))
    (Comment 11) One comment requested clarification about the caution
statement required on labeling and advertising for VFD drugs and feeds
containing VFD drugs. The comment recognized that for products in paper
bags this would be appropriate, but wondered what would be required for
feed that is delivered in bulk where there is no container.
    (Response 11) As reflected in the regulatory text, all labeling and
advertising for VFD drugs, combination VFD drugs, and feeds containing
VFD drugs or combination VFD drugs must prominently and conspicuously
display the cautionary statement. In section 201(m) of the FD&C Act (21
U.S.C. 321(m)), ``labeling'' is defined as ``all labels and other
written, printed, or graphic matter (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.'' Packaged
food typically has a label affixed to the package or container;
however, any labeling or advertising would also need to contain the
statement. Bulk food typically does not have a label affixed to the
container, but is accompanied by labeling to meet other requirements of
the FD&C Act, such as displaying the common or usual name of the animal
food, as well as any other information already required by existing
regulations. FDA would expect that the caution statement be on this
labeling, as well as any other labeling or advertising for the bulk
food.
c. Length of Time VFD and Records Must Be Kept (Sec.  558.6)
    In the December 2013 NPRM, we proposed to reduce the length of time
a VFD and records related to a VFD must be kept from the currently
required 2 years to 1 year. We received many comments related to this
requirement. After further considering this issue, we are retaining the
existing 2-year recordkeeping requirement.
    (Comment 12) We received many comments requesting FDA to maintain
the current 2-year recordkeeping requirement. We also received several
comments supporting the proposed 1-year recordkeeping period. Some of
these comments supported the 1-year requirement because many VFD
records are also required to be kept under the CGMP recordkeeping
requirements for medicated feeds found in part 225 (21 CFR part 225),
and those requirements specify a 1-year retention period. A few
comments requested a requirement that records related to VFDs be kept
for a period shorter than 1 year, or longer than 2 years.
    (Response 12) In response to comments and after further
consideration of the issue, we are requiring that VFDs and all required
records related to VFDs for veterinarians, clients, and distributors be
kept for a period of 2 years. This record retention period is the same
as the current record retention requirement. Our purpose in proposing
the 1-year recordkeeping requirement in the December 2013 NPRM was to
better align the VFD recordkeeping requirements with those in the CGMP
regulations in part 225 for medicated feed. All records required under
part 558 of this chapter must be kept for 2 years. In addition, as
discussed elsewhere in this document, we believe it is important that
all parties be required to maintain VFD receipt and distribution
records for 2 years, irrespective of whether the party is required to
maintain receipt and distribution records under part 225 of this
chapter. We believe that there are several benefits to a 2-year VFD
record retention period.
    The first benefit is that a 2-year VFD recordkeeping requirement
aligns with the recently published Current Good Manufacturing Practice
and Hazard Analysis and Risk-Based Preventive Controls for Food for
Animals proposed rule (78 FR 64736; October 29, 2013). This proposed
rule includes new CGMP requirements for operations that manufacture,
process, pack, and hold animal food, including animal feed, and
proposes a 2-year records retention period. Some of those recordkeeping
requirements would also fulfill the VFD recordkeeping requirements. We
believe that, because many operators manufacturing or distributing
animal feed bearing or containing VFD drugs may be required to comply
with these proposed CGMP requirements, they would benefit from such a
recordkeeping requirement alignment.
    In addition, while we still believe that a longer retention period
ordinarily will not be critical in order to investigate violative drug
residues in edible animal tissues, the longer record retention period
would provide a more complete history of records, which is useful in
identifying patterns of noncompliance with the VFD regulations during
regular inspections.
    As discussed elsewhere in this document, this final rule adds
clarifying language that distributors who manufacture animal feed
bearing or containing VFD drugs must keep VFD feed manufacturing
records for 1 year in accordance with part 225. These manufacturing
records are not required to be kept for 2 years unless they are also
required to be kept under part 558 of this chapter (e.g., the VFD and
distribution records).
2. Responsibilities of the Veterinarian Issuing the VFD (Sec.
558.6(b))
a. Veterinarian Oversight, Supervision and the Veterinarian Client-
Patient Relationship (VCPR) (Sec.  558.6)(b)(1)).
    FDA is requiring that any veterinarian issuing a VFD be licensed to
practice veterinary medicine and operate in compliance with appropriate
State defined veterinarian-client-patient relationship (VCPR)
requirements or Federally defined VCPR requirements where no applicable
and appropriate State VCPR requirements exist. Some States' licensing
and practice requirements specify that a VCPR as defined by that
State's law must exist before a VFD can be issued. In those States with
VCPR requirements that include the key elements of a VCPR as described
in the Federal definition (Sec.  530.3(i)), FDA intends to defer to the
State VCPR requirement. This has the advantage of being able to
leverage the accountability that comes with State licensing board
oversight to ensure compliance with the VCPR requirement, while
providing States the flexibility to adapt their VCPR requirements
appropriately to local conditions. Although elements of a VCPR are
discussed in the paragraphs that follow, FDA believes that in order for
the State defined VCPR requirements to sufficiently ``include the key
elements of a VCPR as defined in Sec.  530.3(i),'' the State defined
VCPR must at least address the concepts that the veterinarian: (1)
Engage with the client to assume responsibility for making clinical
judgments about patient health, (2) have sufficient knowledge of the
patient by virtue of patient examination and/or visits to the facility
where patient is managed, and (3) provide for any necessary followup
evaluation or care. In States where the practice requirements do not
require that a VFD be issued within the context of a State defined
VCPR, FDA is requiring that the VFD be issued within the context of a
Federally defined valid VCPR.

    (Comment 13) The majority of comments supported maintaining a
veterinarian-client-patient relationship (VCPR) as a requirement for
issuing a VFD. A large number of those comments asked FDA to maintain
the Federal definition of a VCPR because some States either do not
define VCPR in their State licensing and practice requirements, or they
include a VCPR requirement for dispensing prescription drugs or
controlled substances, but not for issuing a VFD. Many comments raised
the specific concern that the veterinarian who issues a VFD should be
required to have recently seen the animals specified in the VFD or
visited the farm on which the animals were kept.
    (Response 13) FDA agrees that a veterinarian-client-patient
relationship is an important element of veterinary supervision and
oversight of the VFD process. As stated in the December 2013 NPRM, our
intent in revising the VCPR provisions was to ``appropriately defer to
existing regulatory oversight standards for veterinary professional
conduct,'' which are overseen by the State organizations responsible
for the licensing of veterinarians. We did not intend to eliminate
requiring a VCPR for the issuance of a lawful VFD. Instead, we intended
to broaden the concept of supervision and oversight to include a VCPR
and other practice requirements as defined by the State to allow for
practice variations and the need for flexibility among State
requirements.
    After reviewing the comments, it is clear that some people have
interpreted our proposed changes as a relaxation of the existing VCPR
requirement. We acknowledge that not all States currently require that
a VCPR must exist before a VFD can be issued and that there is some
uncertainty as to when or if such States will choose to establish such
a requirement subsequent to finalization of this rule. To address
potential gaps in those States that currently lack VCPR requirements
applicable to VFDs, we are changing the regulatory text to specify that
in those States that require a VCPR that includes the key elements of
the Federally defined VCPR in order for a veterinarian to issue a VFD,
the veterinarian issuing the VFD must be operating within the context
of a VCPR as that term is defined by the State. In all other cases, the
veterinarian must be operating within the context of a valid VCPR as
defined by FDA in Sec.  530.3(i).
    A review of the States that have VCPR requirements in place that
are applicable to the issuance of VFDs reveals that those VCPR
requirements typically provide that the animals or premises must
recently have been seen by the veterinarian, or that the veterinarian
otherwise have on-farm knowledge of the animals sufficient to make a
diagnosis. Some States go further, requiring that the animals must have
been seen by the veterinarian within a certain timeframe, or that the
veterinarian has performed an actual examination of the animals. FDA,
therefore, believes that recognizing State professional standards for
issuing a VFD in accordance with VCPR requirements as prescribed by
State law or, where no applicable State VCPR requirements exist,
requiring the VFD to be issued in compliance with Federally defined
VCPR requirements, addresses the concern raised by these comments that
some States currently lack VCPR requirements applicable to VFDs, as
well as the concern that the veterinarian should be required to have
recently seen the animals specified in the VFD or visited the farm on
which the animals are kept.
    (Comment 14) A large number of comments did not specifically
mention a VCPR requirement, but more broadly supported veterinary
supervision and oversight of the VFD process.
    (Response 14) We agree that veterinary supervision and oversight is
important in the issuance of a VFD. We believe that the requirements we
have included in the regulatory text will help ensure adequate
veterinarian oversight and supervision over the use of VFD drugs in
animal feed and are responsive to the comments received.
    (Comment 15) A number of comments supported the proposed intent of
the December 2013 NPRM to defer to State standards for the practice of
veterinary medicine. These comments supported allowing flexibility for
States to set practice standards that address the particular needs and
concerns of the State, including the issue of veterinary shortages.
Several comments also supported the intention to recognize professional
expertise and oversight by State licensing boards to enforce
professional conduct and practice requirements.
    (Response 15) We agree that the practice of veterinary medicine has
traditionally been regulated at the State level and that the States
generally are in a better position to establish and enforce the
requirements of the practice of veterinary medicine. However, not all
States have appropriate VCPR requirements specifically applicable to
the issuance of a VFD. As a result, we believe that the approach we
proposed in the December 2013 NPRM to defer to State practice standards
needs to be supplemented with Federally defined VCPR requirements that
apply to States without such requirements, so that all VFDs will
continue to be issued under veterinary supervision and oversight within
the context of a defined and appropriate VCPR. This approach addresses
both our original intent, as well as the concerns raised in the
comments.
    (Comment 16) A number of comments raised the concern that there is
a shortage of veterinarians, or veterinarians with specialized
expertise, in certain geographical areas. One comment said that the
regulation did not fully address the veterinary shortage issue. A few
comments requested that the rule should include an exemption for farms
that have limited access to veterinarians, or FDA should make funds
available to ensure the farms have access to veterinarians for
treatment of sick animals. One comment requested that FDA work with
USDA on an assistance program for small farmers to enable access to
veterinary care and support the study of large animal medicine so more
veterinarians will enter the field. At least one comment cited studies
from the American Veterinary Medical Association (AVMA) and the
Cornucopia Institute documenting the lack of access to affordable and
competent veterinarians in rural areas. This comment also stated that,
according to the American College of Poultry Veterinarians, there are
only 235 veterinarians available to the poultry industry in the United
States. One comment suggested that an exemption be made for farmers who
cannot access a veterinarian and for species where the drug
administration route of best efficacy is feed or water.
    (Response 16) We recognize and share the concerns raised in the
comments regarding the challenges that animal producers may face in
accessing qualified veterinary care. In light of these concerns, FDA
also carefully considered the feedback received on this issue from the
April 2012 draft proposed regulation and the 2013 public meetings with
stakeholders in rural areas to identify regulatory changes that might
help to mitigate this concern. For example, FDA's intent in proposing
in the December 2013 NPRM to remove the ``one-size-fits-all'' Federally
defined VCPR standard was to allow the veterinary profession and States
the flexibility needed ``to adjust the specific criteria for a VCPR to
appropriately align with current veterinary practice standards,
technological and medical advances, and other regional considerations''
(78 FR 75515 at 75518). In the NPRM, we stated that this greater
flexibility ``could allow veterinarians to

more effectively provide services to food animal producers in remote
geographical areas where veterinary professional resources are limited
and distances are great'' (78 FR 75515 at 75518). We believe this
proposed change provides the flexibility needed for States with a VCPR
requirement for VFDs to address the concern regarding access to
qualified veterinary care. As stated in ``Response 13,'' of this
section, for States that do not have an appropriate VCPR requirement as
part of their VFD regulations, we are adding a requirement to this
final rule that when issuing VFDs, veterinarians must operate within
the context of a valid VCPR as defined by FDA in Sec.  530.3(i). We
believe that this approach strikes the appropriate balance, allowing
adequate flexibility for States to account for limited veterinary
resources while still providing a Federal assurance of appropriate
oversight.
    As veterinary oversight of the therapeutic use of certain medically
important antimicrobials is phased in, FDA will continue to seek
opportunities to work with our Federal, State, and other stakeholder
partners to help address the practical issues associated with limited
access to veterinary services in certain parts of the country.
    (Comment 17) A few comments raised the concern that requiring
veterinarian supervision and oversight would impose an unreasonable
financial burden on small farmers. As a solution, these comments stated
that a VCPR should be required only for confinement agricultural
feeding operations and farms with more than $300,000 turnover, and
small producers should be exempt from VCPR requirements. One comment
suggested an exemption for species where the feed or water route of
administration is the only practical means of effectively administering
antimicrobial therapy.
    (Response 17) We disagree that the requirements for veterinarian
supervision and oversight should not apply to the VFDs issued to small
farmers or for certain species. Section 504 of the FD&C Act (21 U.S.C.
354) requires that VFD drugs be used under a veterinarian's
supervision. As a result, veterinary supervision for the use of VFD
drugs is required, whether or not certain animal producers or
operations would be exempt from State or Federally defined VCPR
requirements. Therefore, exempting small animal producers or certain
species from VCPR requirements would not likely result in any cost
savings for their use of VFD drugs because the statute requires the
veterinarian to be involved in the issuance of a VFD. In addition, it
would be difficult and confusing for veterinarians to determine whether
such an exemption would apply. For these reasons, FDA does not believe
that this proposal is a viable solution.
    Furthermore, FDA does not believe that continuing to require a
VCPR, whether State or Federally defined, to issue a VFD results in an
unreasonable financial burden on animal producers. FDA continues to
believe that veterinary oversight of the use of medically important
antimicrobial drugs in feed is a critical measure for ensuring
judicious use of these drugs in support of efforts to minimize
antimicrobial resistance. Maintaining a requirement for an appropriate
VCPR is a fundamental element of providing for meaningful veterinary
oversight. FDA will continue to seek opportunities to work with our
Federal, State, and other stakeholder partners to help address the
practical issues that arise as veterinary oversight of the therapeutic
use of certain medically important antimicrobials is phased in.
    (Comment 18) A few comments stated that the requirement for
supervision and oversight was not clear, or advocated for specific
requirements to be included as part of supervision and oversight. These
comments requested more specific guidelines describing the amount of
time the veterinarian must spend on the farm or ranch, how recently the
veterinarian must have seen the animals or farm, whether the
veterinarian needs to see the animals or visit the farm in person, and
what it means for a veterinarian to be familiar with the client's
operation. The comments also expressed concern that veterinarians be
licensed in each State where there is a facility under the operation,
and that the facility should be recently visited so that the
veterinarian is familiar with the local conditions in which the animals
are raised.
    (Response 18) We have addressed these concerns by including more
specific language about the requirements for veterinary supervision and
oversight, including compliance with State licensing and practice
requirements and the continued role of a VCPR in Sec.  558.6(b)(1). The
State and Federal definitions of VCPR set out the requirements for the
veterinarian to establish an appropriate relationship with the client
and the animal(s) for which services are being provided.
    The first element of the Federal VCPR is that ``A veterinarian has
assumed the responsibility for making medical judgments regarding the
health of (an) animal(s) and the need for medical treatment, and the
client (the owner of the animal or animals or other caretaker) has
agreed to follow the instructions of the veterinarian'' (Sec.
530.3(i)(1)). For the States that define a VCPR, all but one State
includes in their definition a statement about the responsibility the
veterinarian assumes in making medical judgments about the animal's
health. Many of the States go further and specify the owner or animal
producer's responsibility to follow the veterinarian's instructions.
    The second element of the Federal definition of VCPR states that
``There is sufficient knowledge of the animal(s) by the veterinarian to
initiate at least a general or preliminary diagnosis of the medical
condition of the animal(s) . . .'' (Sec.  530.3(i)(2)). In addition,
the definition states that ``[s]uch a relationship can exist only when
the veterinarian has recently seen and is personally acquainted with
the keeping and care of the animal(s) by virtue of examination of the
animal(s), and/or by medically appropriate and timely visits to the
premises where the animal(s) are kept'' (Sec.  530.3(i)(3)). Typically,
a veterinarian has an ongoing relationship with the client and the
client's animals being treated such that the veterinarian is familiar
with the animal production operation and has made previous visits to
their facility(s). This relationship also allows the veterinarian to
provide education to the client about appropriate use of medication,
including storage, use, and withdrawal times. FDA expects that a
veterinarian will only authorize use of a VFD feed in animals for which
he or she has such knowledge and familiarity. For the States that
define a VCPR, all but one State includes in their definition a
statement about the veterinarian's knowledge of or acquaintance with
the animal or operations. Most of the States that incorporate this
knowledge or acquaintance criterion in their VCPR definition provide
similar detail to the Federal definition about what constitutes
sufficient knowledge, such as requirements that the veterinarian has
recently seen and is personally acquainted with the keeping and care of
the animal(s) by an examination or medically appropriate and timely
visits. Some States are even more specific and specify the time period
in which the animal must have been seen by the veterinarian. A few
States do not have a knowledge or acquaintance criterion, but instead
require that the veterinarian has actually examined the animal or a
representative segment of the consignment or herd. Thus, in most
States, these requirements regarding responsibility are the same or
similar to the current Federal definition.

    The third element of the Federal VCPR is that ``The practicing
veterinarian is readily available for followup in case of adverse
reactions or failure of the regimen of therapy'' (Sec.  530.3(i)(3)).
The State VCPR definitions vary the most among each other and from the
Federal definition in what they require regarding followup care. Seven
States that define VCPR do not specify in their VCPR a requirement for
followup veterinary availability. The primary role of the veterinarian
in issuing a VFD is the supervision and oversight needed for the
issuance of the VFD and feeding of the VFD feed. Even though some
States do not have specific requirements about how readily available
the veterinarian must be for followup, these States all have a
requirement that the veterinarian is knowledgeable of, or acquainted
with the animals, or farm, and/or the veterinarian has assumed the
responsibility for making medical judgments regarding the health of the
animal and its need for medical treatment.
    Most of the States that have a VCPR requirement that applies to the
issuance of VFDs define a VCPR in a manner consistent with the Federal
VCPR. Like the Federally defined VCPR, the key elements of a VCPR for
many of these States includes the requirements that the veterinarian
issuing a VFD assume responsibility for the medical care of the animal
and have sufficient knowledge of the animal or herd based on having
recently seen and being personally acquainted with the keeping and care
of the animals and/or perform an actual examination of the animal or
herd or make timely visits to the operation. For that reason, we
believe that deferring to the State VCPR standard for those States that
define an appropriate VCPR applicable to VFDs will allow States the
needed flexibility to factor regional considerations into their VCPR
requirements while, at the same time, continuing to provide sufficient
protection for human and animal health. In those States that do not
define a VCPR that includes the key elements in the Federally defined
VCPR, or in the States that define a VCPR but do not require it for the
issuance of a VFD, the veterinarian is required to issue the VFD within
the context of a valid VCPR as that term is defined by FDA at Sec.
530.1(i). FDA will work with States to finalize its list of the States
that have an appropriate VCPR that applies to VFDs. Once that task is
complete, FDA will communicate that information to the public as part
of the implementation of this final rule. FDA will also continue to
work with the States and veterinary associations to foster the adoption
of VCPR definitions that are sufficiently rigorous to ensure meaningful
veterinary supervision and oversight.
    With respect to the comment suggesting that a veterinarian who
writes VFDs for a particular animal production operation needs to be
licensed in each State where that operation has a facility, we disagree
that such a requirement is necessary unless such licensing is required
by the States where those facilities are situated. In other words, the
veterinarian needs to be in compliance with the licensing requirements
in the State(s) in which he or she is practicing veterinary medicine.
The State laws and rules for licensing and practice determine for what
activities a license is necessary and whether reciprocity or other
programs that recognize licensure in another State may apply. It is the
responsibility of the veterinarian to be familiar with the licensing
and practice requirements for his or her activities in each State in
which he or she practices veterinary medicine. A client who operates in
multiple States may engage with one veterinarian who is in compliance
with all of those States' licensing requirements, or may choose to
engage more than one veterinarian to ensure that a veterinarian is
available who complies with each of those States' licensing and
practice requirements.
    (Comment 19) Some comments raised concerns with FDA's proposed
language and the potential impacts on public health if the Federal VCPR
standard is eliminated. Comments also expressed concern with the lack
of a description or explanation in the NPRM of how the Federal standard
is overly burdensome, how State regulations and voluntary ethical
principles will adequately substitute for a VCPR, and why a Federally
defined VCPR is unnecessary to ensure appropriate use of VFD drugs when
it is appropriate to guide drug use in other contexts.
    (Response 19) As discussed elsewhere in this document, our
intention was not to eliminate a VCPR standard, but instead to provide
the flexibility of relying on States' standards for veterinary
professional conduct, which are based on current veterinary practice
standards, technological and medical advances, and other regional
considerations. As discussed elsewhere in this document, based on the
State defined VCPR standards that exist currently, we believe that an
appropriate State defined VCPR standard affords a level of veterinarian
supervision and oversight similar to the Federal VCPR standard, and
helps ensure animals are being provided VFD drugs judiciously and for
approved indications. Therefore, we do not think that this change will
affect public health.
    We stated in the December 2013 NPRM that our intent was to provide
greater flexibility for veterinarians by deferring to the individual
States for the specific criteria for acceptable veterinary professional
conduct. In the final rule, the Agency has affirmed its decision to
defer to State practice standards for acceptable veterinary
professional conduct when those standards require a VCPR for the
issuance of a VFD that includes the key elements of the Federally
defined VCPR standard. In response to comments that some State practice
standards do not require a VCPR for the issuance of a VFD, and because
a VCPR is an important part of veterinarian supervision and oversight
in the VFD process, we will require adherence to the Federally defined
VCPR if an applicable and appropriate State VCPR standard is not in
place.
    As we have stated previously, many States have defined VCPR, and
require a VCPR to exist in order for a veterinarian to issue a VFD.
Many States also explicitly adopt the AVMA Principles of Veterinary
Medicinal Ethics as part of their practice requirements, which includes
a VCPR definition (Ref. 8). For States with a VCPR definition that does
not include key elements of the Federally defined VCPR, or who do not
require a VCPR for issuing a VFD, language in the regulatory text
requires veterinarians to issue VFDs in compliance with the Federally
defined valid VCPR. For the reasons stated previously, FDA believes a
hybrid State and Federal VCPR approach is appropriate to help ensure
sufficient veterinary oversight and supervision for the use of VFD
drugs in or on animal feed.
    (Comment 20) Several comments were concerned that the elimination
of the Federally defined VCPR as proposed in the NPRM would result in
FDA no longer being able to take enforcement action against
veterinarians who issue a VFD for animals outside the context of a
VCPR. Several comments supported FDA engaging in outreach and education
to feed mills and veterinarians on the subject of veterinarian
supervision and oversight as it pertains to VFDs as part of this
Agency's compliance and enforcement processes.
    (Response 20) We agree that it is important for regulations to be
enforceable. The approach in the regulatory text allows either the
States

or FDA to take enforcement action, depending upon the VCPR requirements
at issue. If a veterinarian issues a VFD without complying with
applicable State licensing and practice requirements, including VCPR,
the State may take enforcement action and FDA may determine the
resulting animal food to be adulterated or misbranded. If the Federally
defined valid VCPR standard is applicable and the veterinarian fails to
comply, FDA may act to enforce compliance. In addition, if the
veterinarian is not complying with State licensing or practice
requirements, or is not issuing a VFD within the context of the
applicable State or Federally defined VCPR, the VFD issued will not be
lawful. A VFD drug is limited by the terms of its approval, conditional
approval, or index listing to use in or on animal feed only under a
lawful VFD. If animal feed containing a VFD drug is fed to animals
without a lawful VFD, then the VFD drug would be considered unsafe
under section 512(a)(1) of the FD&C Act (21 U.S.C. 360b(a)(1)) and
adulterated under section 501(a)(5) (21 U.S.C. 351(a)(5)) of the FD&C
Act. In addition, the animal feed bearing or containing the VFD drug
will be considered adulterated under section 501(a)(6) of the FD&C Act.
A VFD drug and animal feed containing such a drug also will be
considered misbranded under section 502(f) of the FD&C Act (21 U.S.C.
352(f)) unless the drug and feed are labeled, distributed, held, and
used in compliance with the applicable VFD requirements.
    FDA is committed to working with the State entities that license
veterinarians in order to ensure that appropriate action is taken if
the veterinarian does not issue VFDs in the context of an appropriate
VCPR, or does not follow State licensing or practice requirements.
    (Comment 21) A few comments requested clarification about the use
of the terms ``veterinary supervision'' and ``veterinary oversight'' as
used in the VFD regulation. The comments asked whether ``oversight''
means something different than the term ``supervision'' which is used
in section 504, or whether the two terms are meant to be synonymous.
The comments were concerned that oversight could be performed in place
of supervision and that it was a less-stringent standard. One comment
requested that FDA define ``supervision or oversight'' to mean that the
veterinarian has visited the premises at least once per year or
documented why an alternative visitation schedule is more appropriate.
    (Response 21) For purposes of this regulation, the term
``oversight'' is meant to be a synonym of ``supervision.'' The phrase
``supervision or oversight'' was introduced in order to tie the
oversight language FDA has used in other documents to the concept of
veterinary ``supervision,'' which is the term used in section 504 of
the FD&C Act. As discussed previously, the VCPR which is required for
issuing a VFD controls how recently a veterinarian needs to have
examined the animals or operation. As a result, FDA does not find it
necessary to define the phrase ``supervision or oversight'' to mean
that the veterinarian has visited the premises within a specific
timeframe.
    (Comment 22) A few comments were concerned about a potential
conflict of interest between the veterinarian and the client. One
comment said that the veterinarian should not have a fiduciary tie to
production. One comment said that an oversight committee should be
established to independently approve antibiotic use.
    (Response 22) We understand the concern raised by these comments.
However, most State practice requirements have a standard of ethics
that addresses what constitutes a conflict of interest and the ethical
standards veterinarians must observe in such circumstances. The
requirement for the veterinarian issuing the VFD to comply with all
State practice requirements includes compliance with standards of
ethical conduct.
    We disagree that an oversight committee should be established to
independently approve antibiotic use. Currently, there are several
points of oversight in the use of antibiotics. The drug is first
reviewed for safety and effectiveness as part of the approval or
indexing process. During this process, parameters are set that limit
the drug's use to certain conditions and for certain approved uses, as
reflected on the drug's approved labeling (Refs. 9, 10, and 11). In
addition, VFD drugs are required to be used under a veterinarian's
supervision. The veterinarian's role is to make a medically-based
decision as to whether a particular VFD drug or combination VFD drug is
appropriate for the treatment, control, or prevention of a specific
disease. Should the veterinarian determine that a VFD drug should be
used, he or she can only use the drug as stated on the approved
labeling of that drug. Extralabel use (ELU) of medicated feed,
including VFD feed, is prohibited by statute.
    Furthermore, as part of the effort to implement the objectives of
the National Strategy for Combating Antibiotic Resistance published in
September 2014, FDA will be working with veterinary organizations,
animal producer organizations, and other partners to identify and
implement measures to foster stewardship of antibiotics in animals.
These measures include educational outreach to veterinarians and animal
producers to advance antibiotic stewardship and judicious use of
antibiotics in agricultural settings (Ref. 12).
    (Comment 23) Several comments supported ELU being allowed by
veterinarians for VFD drugs.
    (Response 23) ELU of a new animal drug in or on animal feed is
illegal and results in the drug and feed being deemed unsafe under
section 512(a) of the FD&C Act and adulterated under sections 501(a)(5)
and (6) of the FD&C Act.
b. Veterinarian Licensing Information
    In the December 2013 NPRM, we proposed to remove the requirement
that veterinarians include their license number and the name of the
issuing State on the VFD. We received several comments on this issue
and, after consideration of these comments, we are finalizing our
proposal to not require veterinary licensing information on the VFD.
    (Comment 24) One comment requested that we require the veterinarian
to list their license number and State of licensure on the VFD for
traceability and accountability. This comment indicated that these
requirements were not a burden on the veterinarian because
veterinarians use preprinted forms, and adding this information to
their electronic signature is a one-time effort that takes only minutes
to complete. A few comments supported the proposed change because they
thought the required name and address of the veterinarian on the VFD
would be sufficient if follow up with the veterinarian ever became
necessary.
    (Response 24) We disagree that including the veterinarian's license
number and State of issuance on the VFD is necessary for traceability
or accountability. The issuing veterinarian's name and address is
sufficient for FDA to work with the State veterinary licensing boards
to determine licensure status, in the event that there is a concern
that a VFD has been illegally issued. Also, many State licensing boards
maintain an online database that allows the public to search for a
veterinarian's licensing status by their name.
    We disagree that the low burden is outweighed by the benefit of
requiring this information, because we do not believe that this
information provides any additional benefit to determining the
licensure status of veterinarians.

Even if this information were to be required on the VFD, we would still
need to perform an investigation into the licensing status of the
issuing veterinarian in the event that there was a concern and the
veterinarian's name and address is sufficient information to perform
that investigation. In addition, some veterinarians may choose not to
use preprinted forms or electronic signatures. For veterinarians who do
not use preprinted forms or electronic signatures, the recordkeeping
burden would be substantially greater than the comment suggests.
Because this information would create a time burden for the
veterinarian and does not provide information that aids our ability to
investigate a veterinarian's licensure status, we are not including
this requirement in the final regulatory text.
c. Name of Animal Drug (Sec.  558.6(b)(3)(vi))
    (Comment 25) One comment requested clarification on whether it is
allowable to use an approved generic VFD drug as a substitute for an
approved pioneer VFD drug in cases where the pioneer VFD drug is
identified on a VFD.
    (Response 25) The veterinarian is required to write the name of the
VFD drug on the VFD. The veterinarian may choose to write the name of
the pioneer or a generic (if available) VFD drug to complete this
requirement. The veterinarian may choose to specify that a substitution
by the feed manufacturer of either the pioneer or generic VFD drug
identified on the form is not allowed. If the veterinarian does not
specify that a substitution is not allowed, the feed manufacturer may
use either the approved pioneer or an approved generic VFD drug to
manufacture the VFD feed. However, the feed manufacturer may not
substitute a generic VFD drug for a pioneer VFD drug in a combination
VFD feed if the generic VFD drug is not part of an approved combination
VFD drug.
d. Client Name and Address (Sec.  558.6(b)(3)(ii))
    (Comment 26) A few comments requested clarification about whether
the feedlot manager's information is the correct information for the
client name and address.
    (Response 26) The client name and address should reflect the client
in the veterinarian-client-patient relationship, which is typically the
person responsible for feeding the animals the VFD feed. In many cases,
a feedlot manager may be the appropriate individual.
e. Premises at Which the Animals Specified in the VFD Are Located
(Sec.  558.6(b)(3)(iii))
    The December 2013 NPRM proposed to retain the existing requirement
that the location of the animals be specified on the VFD. In the
proposed language, this requirement was listed separately from the
required information about the number and species of animals. The NPRM
also proposed to allow the issuing veterinarian, at his or her
discretion, to provide more detailed information about the location of
the animals to be fed the VFD feed. The regulatory text in this final
rule reflects the approach proposed in the NPRM.
    (Comment 27) A few comments suggested that the site or location at
which the animals are located be determined broadly (i.e., the location
of the premises where animals are located, but not the specific pen or
confinement unit). A few comments were concerned that animals move
throughout their life cycle and it may be difficult to identify one
location.
    (Response 27) We expect that, in response to the requirement to
enter information describing the premises where the animals are
located, the veterinarian would enter information about the location of
the animals that would allow someone to locate the animals. Typically,
the address would be an appropriate way to identify the location;
however, other generally recognized geographical indicators such a
global positioning system (GPS) coordinate may be appropriate if a
street address does not exist.
    We recognize that an address for a facility may not provide enough
information to identify the location of animals in a case where the VFD
is meant to authorize that a very specific group of animals receive the
animal feed bearing or containing the VFD drug. As a result, the
veterinarian may use his or her discretion to enter additional
information on the VFD that more specifically describes the location of
the animals such as the site, pen, barn, stall, tank, or other
descriptor. The veterinarian should consult with the client to
determine whether the animals will remain at this more specific
location until the expiration date of the VFD.
    We understand that some groups of animals that are of similar age,
weight range, etc., are managed in a similar manner, but may be housed
in different physical locations. For example, a group of weaned pigs
may be moved out of a nursery facility and transferred to multiple
grow-out facilities for finishing. If a VFD is intended to authorize
the use of a VFD feed in an identified group (approximate number) of
animals that are located at more than one physical location, it is
acceptable for a veterinarian to include multiple specified locations
for that group of animals on the VFD. The veterinarian may write a VFD
that covers animals in multiple locations (animal production
facilities) to be fed the VFD feed by the expiration date on the VFD,
provided he or she can do so in compliance with professional licensing
and practice standards and provided the VFD feed is supplied to such
multiple locations by a single feed manufacturer (distributor).
f. Expiration Date (Sec.  558.6(b)(3)(v))
    The December 2013 NPRM proposed to add new language to the
requirement that the veterinarian enter the expiration date of the VFD
on the form. The new language limits the veterinarian to using the
expiration date that is specified in the approval, conditional
approval, or index listing. Where such date is not specified, the
veterinarian can write a VFD with an expiration date that does not
exceed 6 months after the date of issuance of the VFD. The regulatory
text in this final rule reflects this approach, with clarified
language.
    (Comment 28) Many comments supported the 6-month expiration period.
Some comments also requested that the VFD expire when an animal is
deceased, at 6 months, or based on the expiration date specified in the
approved labeling, whichever is shorter.
    (Response 28) We agree that a maximum 6-month expiration date in
the absence of an expiration date specified in the approval,
conditional approval, or index listing is appropriate. The date of
expiration should be calculated by the calendar date, not the number of
days. This will allow for easy calculation by veterinarians in the
field. For example, using a 6-month expiration date for a VFD, if the
VFD is written on July 10, then the expiration date would be January 10
of the following year. Using the same 6-month expiration date example,
but having the VFD written on the last day of the month, the VFD
expiration date would be the last day of the sixth month even if that
month has fewer days. Thus, in this example, if the VFD is written on
August 31, the expiration date would be the following February 28
during a regular calendar year, or February 29 during a leap year.
    With respect to the comments requesting to have the VFD expire when
an animal is deceased, at 6 months, or based the expiration date
specified in the approved labeling, whichever is shorter, we do not
agree with these

comments. Having the VFD expire when an animal is deceased is not
practical because one death in a herd or flock of animals would result
in an unlawful VFD. However, if there is no expiration date specified
in the approval, conditional approval, or index listing, the
veterinarian may write an expiration date shorter than 6 months based
on their medical judgment and taking into account factors such as the
life cycle of the animals being treated. If there is an expiration date
specified in the approval, conditional approval, or index listing, then
the veterinarian has to use that date and may not write a shorter or
longer expiration date for the VFD. Deviating from the expiration date
specified by the approval, conditional approval, or index listing would
constitute ELU, which is prohibited by section 512(a) of the FD&C Act.
    (Comment 29) Many comments requested the expiration period be
shorter than 6 months. One comment requested that the VFD expire at the
end of treatment. Some comments recommended expiration periods of 21
and 30 days. One comment recommended that the maximum expiration period
be shortened to 90 days if VFD drugs are used for unapproved uses or
for longer than 6 months, with the possibility of extension upon
reassessment.
    (Response 29) We disagree that a shorter expiration period is
necessary for VFD drugs that do not specify an expiration date in their
approval, conditional approval, or index listing. Even though a VFD can
be written for a 6-month period does not mean the veterinarian will
write all VFDs with a 6-month expiration date. The veterinarian will
use his or her medical judgment to determine what expiration date is
appropriate for the VFD, based on many factors including, but not
limited to, the type of animal production facility and operation, the
VFD drug or combination VFD drug at issue, the intended use of the VFD
drug, and the health status, treatment history, and life cycle of the
animals.
    Also, a maximum expiration period of 6 months does not necessarily
mean that the animals will consume the feed containing the VFD drug for
6 months. Rather, an expiration period of 6 months means that the
authorization to feed the specified VFD product is lawful for 6 months.
The veterinarian is also required to include on the VFD the duration of
use, which limits the amount of time the animal feed bearing or
containing the VFD drug can be fed. The duration of use must follow the
duration that is specified in the approval, conditional approval, or
index listing even if it is a shorter timeframe than the expiration
date. If the veterinarian issues a new VFD after the expiration date of
the first VFD, they can use their medical judgment, taking into account
factors such as the life cycle and treatment history of the animal, to
consider what expiration date would be appropriate for the new VFD, up
to the 6-month maximum for VFD drugs that do not specify an expiration
date in the approval, conditional approval, or index listing.
    We disagree that a shorter VFD expiration period should be in place
for VFD drugs used for unapproved uses, or those used longer than 6
months. Medicated feeds, including those bearing or containing a VFD
drug, cannot legally be used in an extralabel (unapproved) manner; such
use is prohibited by statute. As explained previously, the expiration
date of the VFD does not control how long the VFD drug is to be used,
but rather defines when it must be used by (i.e., the period of time
for which the authorization is lawful).
    (Comment 30) Some comments requested that the maximum expiration
date of a VFD be longer than 6 months. Most of these comments requested
that the VFD expiration date be a maximum of 1 year.
    (Response 30) We disagree that a maximum expiration date for a VFD
should be longer than 6 months for VFD drugs that do not have an
expiration date specified in their approval, conditional approval, or
index listing. We think that a 6-month maximum VFD expiration date
permits veterinarians, based on their medical judgment and knowledge of
the animal production operation, to determine on a case-by case basis
whether the maximum 6-month period is an appropriate expiration date
for the VFD or whether a more limited period is warranted. When deemed
appropriate, we expect that flexibility in applying the VFD expiration
date can substantially reduce the administrative burden associated with
issuing VFDs for a given animal production operation. Limiting the
expiration to a maximum of 6 months ensures that the veterinarian is
required, at least every 6 months, to review whether factors such as
the type of animal production operation, animal health, or the need to
use a VFD drug have changed when considering whether to issue another
VFD.
    (Comment 31) Several comments requested clarification about how the
VFD expiration date relates to refills and reorders, the duration of
use and the concept of standing orders. Several comments supported VFD
drugs having clear limits on the duration of use. These comments did
not specifically recommend an expiration date, but offered support for
the risk criteria in GFI #152, ``Evaluating the Safety of Antimicrobial
New Animal Drugs with Regard to Their Microbiological Effects on
Bacteria of Human Health Concerns.'' Several comments were concerned
that a VFD drug could be continuously used. Some of these comments
requested that FDA not permit the continuous use of a VFD drug.
    (Response 31) As previously discussed, the VFD expiration date
defines the period of time for which the authorization to feed an
animal feed containing a VFD drug is lawful. This period of time may be
specified in the approved labeling of a given VFD drug (e.g., 45 days
for tilmicosin) or, if not specified in the labeling, the veterinarian
must specify an expiration date that does not exceed 6 months. The
duration of use is a separate concept than the expiration date and
determines the length of time as established as part of the approval,
conditional approval or index listing process that the animal feed
containing the VFD drug is allowed to be fed to the animals. This
period of time is specified in the labeling of the VFD drug (e.g., 21
days for tilmicosin). For example, the currently approved VFD drug
tilmicosin has an expiration date of 45 days, which means the client
has 45 days to obtain the VFD feed and complete the 21 day course of
therapy (Sec.  558.618). Animals cannot legally be fed the VFD feed
after the VFD expiration date.
    We acknowledge the comments seeking limits on the duration of use
of VFD drugs. However, the duration of use of VFD drugs (i.e., how long
the drug is to be given to the animals) is not determined by the VFD
regulation, but rather is established as part of the approval,
conditional approval, or index listing process and is based on the
scientific information submitted about the VFD drug. A VFD issued by a
licensed veterinarian authorizes a client to feed the VFD feed to the
client's animals. The expiration date of a VFD is the length of time
that such authorization is lawful. In contrast, the duration of use
limits the length of time that the animals can be fed the animal feed
containing the VFD drug. Thus, in the example of tilmicosin, the
approval allows a VFD expiration date of 45 days, but the duration of
use (i.e., how long the drug is to be given to the animals) is limited
to 21 days.
    Similar to the concept of refilling a prescription for 30 tablets
with another 30 tablets, a refill or reorder in the VFD

context is meant to apply when the feed authorized under the VFD has
been exhausted. The refill or reorder would provide authorization to
obtain and feed additional VFD feed in the same total quantity and
under the same conditions of the existing VFD by the expiration date of
that VFD. A veterinarian can only authorize refills or reorders if the
labeling of the product in question explicitly permits them. Currently,
there are no approved VFD drugs that allow refills or reorders as a
condition of their approval, conditional approval, or index listing.
    FDA anticipates that the appropriate use of refills or reorders
could vary considerably depending on the VFD drug and its use. Since we
cannot predict what disease conditions, and what types of VFD drugs for
the treatment, control, or prevention of those diseases, may exist in
the future, appropriate limitations regarding refills and reorders and
how they relate to the expiration date of the VFD must be considered on
a case-by-case basis as part of the new animal drug approval process.
In the context of antimicrobial VFD drugs, FDA envisions that the
refill/reorder concept will have limited applicability.
    The term ``standing order'' is not used in the regulatory text
included in this final rule, but has been used in public meetings and
by industry to refer to the situation in which a veterinarian issues a
VFD for a VFD drug that does not have a label-defined VFD expiration
date; therefore, the veterinarian is required to apply a VFD expiration
date that does not exceed 6 months from the time the VFD is issued. In
such a case, the veterinarian, in the context of a VCPR, would use his
or her medical judgment and knowledge of the animal production facility
and operation to determine the therapeutic needs for the VFD drug by
the expiration date established by the veterinarian. As a result, the
client would have the VFD authorization in place and could more quickly
get the animal feed containing the VFD drug manufactured if and when
the animals needed treatment. In addition, this practice would allow
for clients with limited access to veterinarians to be able to receive
a VFD within the confines of a VCPR and use it at a later date, but
within the expiration date of the VFD, when the need for use of the
animal feed containing the VFD drug occurs.
g. Approximate Number of Animals To Be Fed the VFD Feed by the
Expiration Date on the VFD (Sec.  558.6(b)(3))
    In the December 2013 NPRM, FDA proposed removing the requirement
for a veterinarian to identify the amount of feed to be manufactured
under the VFD, and modified the requirement to identify the number of
animals to instead require the veterinarian to identify the approximate
number of animals to be treated under the VFD.
    (Comment 32) Multiple comments supported changing the requirement
to identify the amount of feed manufactured to instead identify the
approximate number of animals on the VFD. These comments recognized the
current problems with calculating the amount of feed, including the
need to write additional VFDs when feed volume is underestimated and
recordkeeping for delivery of feed that only partially fulfills the
amount of feed on the VFD. One comment also stated that this change
will allow the amount of feed required to be determined by the feed
manufacturer, which is how other feed orders are filled.
    (Response 32) FDA agrees that the requirement to state the
approximate number of animals instead of the amount of feed resolves
the problems noted in the comments. FDA agrees that the feed
manufacturer, in consultation with the client, has the experience
necessary to determine the amount of feed that should be manufactured
in order to treat the approximate number of animals identified by the
veterinarian on the VFD.
    (Comment 33) Several comments were concerned that the approximate
number of animals was not clearly defined and were unsure how FDA
intended to use the information in enforcing the VFD regulations. These
comments were unsure of the scientific basis for specifying the number
of animals. The comments were also concerned that the number of animals
can change between the time the VFD is issued and the time it expires,
and the requirement would add to increased time and costs. The comments
requested clarification on the responsibility of the feed mill to
address discrepancies between the number of animals and amount of feed.
    (Response 33) FDA agrees that further clarity is needed for
stakeholders to correctly calculate the approximate number of animals.
Therefore, FDA is including additional language in the regulatory text
at Sec.  558.6(b)(3)(viii) to clarify how the approximate number of
animals should be calculated. The approximate number of animals is the
potential number of animals of the species and production class
identified on the VFD that will be fed the VFD feed or combination VFD
feed manufactured according to the VFD at the specified premises by the
expiration date of the VFD. Because the VFD authorization targets the
animals that need to be fed the VFD feed, FDA believes the approximate
number of animals is an appropriate mechanism to limit the scope of use
authorized by the VFD.
    FDA recognizes that the number of animals to be covered under the
VFD can change by the expiration date; animals may leave or enter the
group being fed the VFD feed manufactured under the VFD for a variety
of reasons. This is why FDA chose to include the term ``approximate''
in the requirement. FDA believes that veterinarians typically have
enough information about the animal production operation to determine
the approximate number of animals that will be entering or leaving the
operation over a specific period of time.
    FDA does not agree that determining the approximate number of
animals will increase time or costs. Calculating the approximate number
of animals should take less time than complying with the previous
requirement to calculate the amount of feed because the calculation
will include fewer factors to take into consideration. Furthermore,
using the approximate number of animals may decrease costs because
clients will have the flexibility to work directly with their feed
supplier to ensure that the appropriate amount of feed is provided for
the approximate number of animals authorized by the VFD. This reduces
the burden of seeking an additional VFD in those cases where, if the
previous requirement to specify the amount of feed on the VFD were
still in effect, the veterinarian may have underestimated the amount of
VFD feed the animals would consume.
    FDA expects the feed mill to share expertise and work with the
client and veterinarian to determine the appropriate amount of feed to
be manufactured for the approximate number of animals authorized by the
VFD and to retain the necessary records to document the amount of feed
that was manufactured under the VFD. FDA expects that feed mills will
only distribute VFD feeds in quantities that are commensurate with the
approximate number of animals as specified by the veterinarian in the
VFD. FDA anticipates that, as part of its inspectional activities, it
will consider such factors as whether the amount of feed manufactured
is reasonable relative to the approximate number of animals specified
in the VFD.
    (Comment 34) One comment was concerned that using the approximate
number of animals would lead to overuse or stockpiling of medicated
feeds, and would potentially remove veterinarian oversight from the
process.

    (Response 34) FDA disagrees with this comment. The veterinarian,
with input from the client, will be responsible for identifying the
approximate number of animals on the VFD. This level of veterinarian
involvement is similar to the veterinarian's current role in
identifying the amount of feed. FDA expects that feed mills will only
distribute VFD feeds in quantities that are commensurate with the
approximate number of animals specified in the VFD. In addition, the
client has the responsibility to use the VFD feed within the
constraints of the VFD as written by the veterinarian.
    Furthermore, FDA does not believe that this change will lead to
over-purchasing, stockpiling or unregulated use of VFD drugs or the VFD
feeds manufactured with them. Medicated feeds can be susceptible to
decomposition if they are stored for lengthy periods of time, making it
unlikely that clients would stockpile economically valuable medicated
feeds. In addition, other requirements on the VFD limit use of the VFD
feed to a specified group of animals for a specified time period, which
will help to regulate use and prevent stockpiling. FDA believes that
feed mills will be able to more accurately determine the amount of feed
to manufacture because they can work with the client as batches of feed
are shipped under the VFD to adjust the amount of feed as feed
consumption rates change among the animals. The Agency believes this
will help to prevent overuse.
    Therefore, FDA is revising the current requirement for the number
of animals to be treated in Sec.  558.6(b)(3)(viii) to mean an
approximate number of animals to be fed the VFD feed by the expiration
date on the VFD, due to the difficulty in determining the exact number
of animals to be treated during the duration of the VFD. In addition,
FDA is removing the existing requirement in Sec.  558.6(a)(4)(vi) for
veterinarians to specify the amount of feed to be fed to the animals
listed on the VFD, as discussed elsewhere in this document.
Veterinarians will instead be required in Sec.  558.6(b)(3)(x) to
include the duration of VFD drug use on the VFD in addition to the
level of VFD drug in the feed, as is currently required.
h. Refills or Reorders Authorized on the VFD (Sec.  558.6(b)(3)(xii))
    In the December 2013 NPRM, FDA added to the language that requires
the number of refills or reorders to be entered on the VFD to account
for refills or reorders allowed as part of a conditional approval, or
index listing in addition to an approval. FDA has updated the proposed
language to clarify that when an approval, conditional approval, or
index listing is silent on refills or reorders, they are not allowed.
    (Comment 35) Some comments supported refills or reorders to
continue to be entered on the VFD if refills or reorders are permitted
by the approval, conditional approval, or index listing. A subset of
these comments requested clarification about how refills or reorders
relate to the other provisions of the VFD regulation and what the
phrase ``permitted by the approval, conditional approval, or index
listing'' means. One comment suggested that the need for refills or
reorders be determined based on the duration of the disease period. One
comment asked FDA to remove this requirement because it is likely to
cause confusion among animal producers, veterinarians, and feed mills,
as many existing OTC products that are changed to VFD status under the
GFI #213 process do not have a refill listed on their label.
    (Response 35) We agree that if a refill or reorder is permitted as
part of the VFD drug approval, conditional approval, or index listing,
the veterinarian is required to indicate on the VFD whether he or she
is authorizing a refill or reorder and if so, the number of refills or
reorders authorized within the limitations permitted by the approval,
conditional approval, or index listing. In order for a refill or
reorder to be permitted, it must be explicitly allowed in the VFD drug
approval, conditional approval, or index listing. Clarifying language
has been added to the regulatory text specifying that when the labeling
for an approval, conditional approval, or index listing is silent in
regards to refills or reorder, a refill or reorder is not permitted.
    A refill or reorder is meant to apply to when the feed authorized
under the VFD has been exhausted. The refill or reorder would provide
authorization to obtain and feed additional VFD feed in the same total
quantity and under the same conditions of the existing VFD by the
expiration date of the VFD. Currently, there are no approved VFD drugs
that allow refills or reorders as a condition of their approval,
conditional approval, or index listing. A veterinarian can only
authorize refills or reorders if the labeling of the product in
question explicitly permits them. Therefore, refills or reorders are
not permitted for an approval, conditional approval, or index listing
of a VFD drug if the label of such product is silent on the labeling
about refills or reorders.
    Although there are no refills or reorders permitted for any current
VFD drug approvals, there may be future VFD drugs that may be
appropriately refilled or reordered as authorized by the veterinarian
on the VFD according to their professional judgment up to the maximum
number permitted by the VFD drug approval, conditional approval, or
index listing. FDA anticipates that the appropriate use of refills or
reorders could vary considerably depending on the VFD drug and its use.
Since we cannot predict what disease conditions, and what types of VFD
drugs for the treatment, control, or prevention of those diseases, may
exist in the future, appropriate limitations regarding refills and
reorders and how they relate to the expiration date of the VFD must be
considered on a case-by-case basis as part of the new animal drug
approval process. In the context of antimicrobial VFD drugs, FDA
envisions that the refill/reorder concept will have limited
applicability.
    If a veterinarian writes a VFD that authorizes a refill or reorder
for a VFD drug that does not permit a refill or reorder, or if the
authorization exceeds the number of refills or reorders permitted, FDA
would consider that to be ELU of the VFD drug. ELU of a drug on or in
animal feed is prohibited by statute.
    (Comment 36) Some comments supported limiting the number of refills
or reorders. Several comments were concerned that without a limit to
refills or reorders, the non-specific use of antibiotics for long
periods of time would be allowed, or that veterinarians could write
unlimited refills. A few comments requested that the requirement to
list the number of refills or reorders on the VFD should be removed
because it is difficult for the feed manufacturer to track.
    (Response 36) FDA agrees that limiting refills or reorders is
appropriate. However, those limitations should be based on the safety
and effectiveness data, and intended use as evaluated and determined at
the time of the VFD drug approval, conditional approval, or index
listing. The approvals and index listings for the current VFD drugs do
not permit refills or reorders.
    FDA disagrees that the requirement to list the number of the
refills or reorders on the VFD should be removed. Should a veterinarian
authorize refills or reorders for a VFD drug as permitted by its
approval, conditional approval, or index listing, this is necessary
information for the feed mill to appropriately manufacture and for the

client to appropriately feed the VFD feed.
i. Combination Drugs (Sec.  558.6(b)(6)(xiv))
    In the December 2013 NPRM, FDA proposed a new provision that would
require the issuing veterinarian to include one of three ``affirmation
of intent'' statements on the VFD regarding the use of a VFD drug in an
approved, conditionally approved, or indexed combination in medicated
feed. These ``affirmation of intent'' statements would either: (1)
Allow the VFD drug to be used in any approved, conditionally approved,
or indexed combination in VFD feed; (2) allow the VFD drug to be used
only in specific approved, conditionally approved, or indexed
combinations in VFD feed; or (3) not allow the VFD drug to be used in
any approved, conditionally approved, or indexed combination in VFD
feed. We received several comments on this new provision and have
revised the language in the regulatory text to provide additional
clarity in response to the comments received.
    (Comment 37) A few comments expressed concern that the veterinarian
would not have sufficient knowledge of approved combination VFD drugs.
They were concerned that the veterinarian would write a VFD allowing a
combination VFD drug that was not approved, conditionally approved, or
indexed, or that he/she would not authorize a VFD for a combination VFD
drug that was approved, conditionally approved, or indexed.
    (Response 37) We understand this concern and have clarified the
language in the regulatory text to more explicitly state the three
``affirmation of intent'' statements the veterinarian may make. These
``affirmation statements'' facilitate the process by which a
veterinarian indicates his or her intent for authorizing the use of a
VFD drug with other drugs (i.e., approved, conditionally approved, or
indexed combination VFD drugs) to make combination VFD feeds. If such
statements were prepopulated on the VFD provided by the sponsor, we
anticipate that the veterinarian would only have to circle, provide a
check mark, or use another method to clearly indicate whether the VFD
drug: (1) May be used in any approved, conditionally approved, or
indexed combination in VFD feed; (2) may be used in only specific
approved, conditionally approved, or indexed combinations in VFD feeds;
or (3) may not be used in any approved, conditionally approved, or
indexed combination in VFD feed. If the VFD drug is approved,
conditionally approved, or indexed for use in multiple combination VFD
feeds, and the veterinarian does not want the VFD drug to be used in
all approved, conditionally approved, or indexed combinations in
medicated feeds, then the veterinarian would need to specify the
combination VFD feed(s) in which the veterinarian is authorizing the
VFD drug to be used.
    This process of affirming intent will reduce the opportunity for a
veterinarian to mistakenly authorize an illegal combination of drugs
when he or she chooses to only authorize the VFD drug to be used in
certain combination VFD feeds. In addition, veterinarians that create
their own VFD can rely on the drug labeling to determine whether the
drug is approved, conditionally approved, or indexed to be used in
combination with another drug or drugs. In the situation where a VFD is
authorizing the use of two or more VFD drugs in an approved,
conditionally approved, or indexed combination in VFD feed, the VFD
must contain information for all of the individual VFD drugs in the
combination. A VFD that authorizes an unapproved combination is not a
lawful VFD because ELU of medicated feeds, including feeds containing
VFD drugs, is prohibited. We think that this approach balances reducing
the risk of an illegal combination being mistakenly included on a VFD
with the need for a veterinarian to be able use his or her medical
judgment to limit the use of a VFD drug in combination with other
drugs.
    (Comment 38) One comment requested that additional information be
provided in the preamble to the final rule explaining how currently
approved, conditionally approved, or indexed combinations of drugs
would be used when drugs included in such combinations are changed from
OTC drugs to VFD drugs.
    (Response 38) We agree that it would be helpful to further clarify
the use of approved, conditionally approved, or indexed combination new
animal drugs containing a VFD drug and one or more OTC or VFD drugs
after such drugs in currently used combinations are changed from OTC to
VFD. If any component drug in an approved, conditionally approved, or
indexed combination drug is a VFD drug, the combination drug is a
combination VFD drug and its use must comply with the VFD requirements.
This is because combination drug products must meet the requirements of
the drug in the combination that is most strictly regulated. In
addition, section 504 of the FD&C Act requires a VFD in order to feed
an animal feed bearing or containing a VFD drug to an animal. This is
the case whether the VFD drug is being used in or on the feed by
itself, or in combination with other OTC or VFD drugs.
    An analogous situation is when an approved, conditionally approved,
or indexed combination drug contains both Category I and Category II
drugs. If the animal feed bearing or containing the combination drug is
manufactured from a Category II Type A medicated article, the mill must
be licensed and follow the requirements for a licensed medicated feed
mill (which are stricter requirements).
j. Veterinarian Must Issue a Written VFD (Sec.  558.6(b)(7))
    (Comment 39) One comment requested that FDA modify the requirement
that a veterinarian may not transmit a VFD by phone to state that the
veterinarian must not verbally transmit a VFD because technology may
allow for a written VFD to be transmitted by a phone.
    (Response 39) FDA proposed in the December 2013 NPRM to change this
provision for the reasons stated in the comment. FDA finalizes this
change in the regulatory text.
k. Contents of the VFD
    (Comment 40) One comment requested that mixing directions not be
allowed on a VFD because they are on the label directions.
    (Response 40) We understand that non-required information that is
placed on the VFD can create confusion and make it more difficult to
locate required information on the form. FDA recommends the amount of
information on the VFD be limited to the required and discretionary
information listed in Sec.  558.6(b)(3) and (4). FDA also recommends
that non-required information the veterinarian chooses to include on a
VFD in addition to the mandatory and discretionary information listed
in Sec.  558.6(b)(3) and (4) be in a place and manner that does not
interfere with the information listed in Sec.  558.6(b).
    (Comment 41) A few comments requested that a uniform VFD format be
required.