This document discusses new FDA regulations regarding the use of medically important antimicrobials in animal agriculture. Specifically, it will require veterinary oversight for these drugs and remove approvals for their use solely for production purposes like growth promotion. Key elements include: drugs affected are those considered important for human medicine and administered via feed or water. A veterinary feed directive (VFD) provides the framework for veterinary oversight of feed use drugs. The VFD regulations specify information required on the directive and responsibilities of veterinarians, distributors, and producers. The changes aim to curb antimicrobial resistance while still allowing therapeutic uses under veterinary guidance.

1. Medically ImportantMedically Important
Antimicrobials inAntimicrobials in
Animal AgricultureAnimal Agriculture
1

2. Outline – Questions to Be AddressedOutline – Questions to Be Addressed
 What changes are being made and why?What changes are being made and why?
 What drugs are affected, which ones are not?What drugs are affected, which ones are not?
 What is a veterinary feed directive?What is a veterinary feed directive?
 What are key elements of VFD regulation?What are key elements of VFD regulation?
 When will this go into effect?When will this go into effect?
2

3. What changes are being made and why?What changes are being made and why?
3

4. Antimicrobial Resistance – In PerspectiveAntimicrobial Resistance – In Perspective
 Complex, multi-factorial issueComplex, multi-factorial issue
 Acquired vs. naturally occurringAcquired vs. naturally occurring
 Use as a driver of resistanceUse as a driver of resistance
 All uses (human, animal, horticultural, other) are part of the pictureAll uses (human, animal, horticultural, other) are part of the picture

5. Antibiotic Use in Animal AgricultureAntibiotic Use in Animal Agriculture
 Subject of scientific and policy debate for decadesSubject of scientific and policy debate for decades
 The science continues to evolveThe science continues to evolve
 Despite complexities and uncertainties steps can be identified to mitigate riskDespite complexities and uncertainties steps can be identified to mitigate risk
 Intent is to implement measures that address public health concern whileIntent is to implement measures that address public health concern while
assuring animal health needs are metassuring animal health needs are met

6. Guidance #209: Outlined AMR policyGuidance #209: Outlined AMR policy
 Describes overall policyDescribes overall policy
directiondirection
6

7. FDA’s Judicious Use StrategyFDA’s Judicious Use Strategy
Two key principles outlined in Guidance #209:Two key principles outlined in Guidance #209:
Limit use of medically important antimicrobial drugs in food-Limit use of medically important antimicrobial drugs in food-
producing animal to those usesproducing animal to those uses
1.1. Considered necessary for assuring animalConsidered necessary for assuring animal health (therapeutichealth (therapeutic
uses.)uses.)
2.2. That include veterinary oversight orThat include veterinary oversight or consultationconsultation
7

8. Guidance #213: ImplementationGuidance #213: Implementation
 Finalized December 2013Finalized December 2013
 More detailed guidance onMore detailed guidance on
implementing key principlesimplementing key principles
in Guidance #209in Guidance #209
 TimelineTimeline
 Defines medically importantDefines medically important
8

9. Guidance #213: OverviewGuidance #213: Overview
 December 2016 - Target for drug sponsors to implement changes toDecember 2016 - Target for drug sponsors to implement changes to
use conditions of medically important antibiotics in food and wateruse conditions of medically important antibiotics in food and water
to:to:
 Withdraw approved production usesWithdraw approved production uses
 such as “increased rate of weight gain” or “improved feed efficiency”such as “increased rate of weight gain” or “improved feed efficiency”
 After the label changes these production uses will no longer beAfter the label changes these production uses will no longer be
legallegal
9

10. Guidance #213: Removing Production UsesGuidance #213: Removing Production Uses
 However, therapeutic uses are to be retained
 treatment, control, and prevention
indications
 Requires transition to veterinary oversight
10

11. Guidance #213: Veterinary OversightGuidance #213: Veterinary Oversight
 Key principle is to include veterinarian in decision-Key principle is to include veterinarian in decision-
making processmaking process
 Does not require direct veterinarian involvement in drugDoes not require direct veterinarian involvement in drug
administrationadministration
 Does require use be authorized by a licensed veterinarian inDoes require use be authorized by a licensed veterinarian in
the context of a VCPRthe context of a VCPR
 This means changing the marketing status fromThis means changing the marketing status from OTCOTC toto
Rx or VFDRx or VFD
 Water soluble products to Rx – “medicated drinking water”Water soluble products to Rx – “medicated drinking water”
 Products used in or on feed to VFD – “medicated feed”Products used in or on feed to VFD – “medicated feed”
11

12. 12
What drugs are affected, which onesWhat drugs are affected, which ones
are not?are not?

13. Guidance #213: ScopeGuidance #213: Scope
 Only affects antibiotics that are:Only affects antibiotics that are:
 ““Medically important”Medically important”
 Administered in feed or drinking waterAdministered in feed or drinking water
 Other dosage forms (e.g., injectable, bolus)Other dosage forms (e.g., injectable, bolus) notnot
affectedaffected in this transition..
13

14. ““Medically Important” antibioticsMedically Important” antibiotics
 Includes antimicrobial drugs that are considered important forIncludes antimicrobial drugs that are considered important for
therapeutic use in humanstherapeutic use in humans
 Guidance #213 defines “medically important” to include:Guidance #213 defines “medically important” to include:
 All antimicrobial drugs/drug classes that are listed in Appendix A of FDA’sAll antimicrobial drugs/drug classes that are listed in Appendix A of FDA’s
Guidance #152Guidance #152
 For a complete list of affected applications see:For a complete list of affected applications see:
 http://http://
www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/Judicwww.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/Judic
14

15. AffectedAffected feed-usefeed-use antibioticsantibiotics
15
Antimicrobial
Class
Specific drugs approved for use in feed
Aminoglycosides Apramycin, Hygromycin B, Neomycin,
Streptomycin
Diaminopyrimidines Ormetoprim
Lincosamides Lincomycin
Macrolides Erythromycin, Oleandomycin, Tylosin
Penicillins Penicillin
Streptogramins Virginiamycin
Sulfas Sulfadimethoxine, Sulfamerazine,
Sulfamethazine, Sulfaquinoxaline
Tetracycline Chlortetracycline, Oxytetracycline

16. AffectedAffected water-usewater-use antibioticsantibiotics
Antimicrobial Class Specific drugs approved for use in water
Aminoglycosides Apramycin, Gentamicin, Neomycin, Spectinomycin, Streptomycin
Lincosamides Lincomycin
Macrolides Carbomycin, Erythromycin, Tylosin
Penicillins Penicillin
Sulfas Sulfachloropyrazine, Sulfachlorpyridazine, Sulfadimethoxine,
Sulfamerazine, Sulfamethazine, Sulfaquinoxaline
Tetracycline Chlortetracycline, Oxytetracycline, Tetracycline
16

17. DrugsDrugs notnot transitioning from OTC to VFD under Guidance #213transitioning from OTC to VFD under Guidance #213
 Antibiotics
 that are already VFD – avilamycin, florfenicol, tilmicosin; or Rx -
Tylosin.
 that are not medically important for example:
 Ionophores (monensin, lasalocid, etc. )
 Bacitracin (BMD, bacitracin zinc)
 Bambermycins
 Carbadox
 Other drugs (that are not antibiotics), including:
 Anthelmentics: Coumaphos, Fenbendazole, Ivermectin
 Beta agonists: Ractopamine, Zilpaterol
 Coccidiostats: Clopidol, Decoquinate, Diclazuril
17

18. What is a veterinary feed directive?What is a veterinary feed directive?
18

19. VFD DefinitionsVFD Definitions
19

20. VFD DefinitionsVFD Definitions
 VFD drugVFD drug ––
 (6) A ‘‘veterinary feed directive (VFD) drug’’(6) A ‘‘veterinary feed directive (VFD) drug’’
is a drug intended for use in or on animalis a drug intended for use in or on animal
feed which is limited by a [CVM] approvedfeed which is limited by a [CVM] approved
application … to use under the professionalapplication … to use under the professional
supervision of a licensed veterinarian. …supervision of a licensed veterinarian. …
20

21. VFD DefinitionsVFD Definitions
 VFD drugVFD drug - …- …
 Use of animal feed bearing or containing aUse of animal feed bearing or containing a
VFD drug must be authorized by a lawfulVFD drug must be authorized by a lawful
veterinary feed directive.veterinary feed directive.
21

22. VFD DefinitionsVFD Definitions
 Veterinary Feed Directive (VFD)Veterinary Feed Directive (VFD) ––
 (7) A ‘‘veterinary feed directive’’ is a written(7) A ‘‘veterinary feed directive’’ is a written
(nonverbal) statement issued by a licensed(nonverbal) statement issued by a licensed
veterinarian in the course of theveterinarian in the course of the
veterinarian’s professional practice thatveterinarian’s professional practice that
orders the use of a VFD drug ororders the use of a VFD drug or
combination VFD drug in or on an animalcombination VFD drug in or on an animal
feed. …feed. …
22

23. VFD DefinitionsVFD Definitions
 Veterinary Feed Directive (VFD)Veterinary Feed Directive (VFD) – …– …
 This written statement authorizes the clientThis written statement authorizes the client
(the owner of the animal or animals or other(the owner of the animal or animals or other
caretaker) to obtain and use animal feedcaretaker) to obtain and use animal feed
bearing or containing a VFD drug orbearing or containing a VFD drug or
combination VFD drug to treat the client’scombination VFD drug to treat the client’s
animals only in accordance with theanimals only in accordance with the
conditions for use approved … by the Foodconditions for use approved … by the Food
and Drug Administration.and Drug Administration.
23

24. Veterinary Feed DirectiveVeterinary Feed Directive
 The framework for veterinary oversight of feed useThe framework for veterinary oversight of feed use
drugs is thedrugs is the veterinary feed directiveveterinary feed directive (VFD) rule.(VFD) rule.
 In 1996 Congress passed Federal Law stating thatIn 1996 Congress passed Federal Law stating that
medicated feeds which require veterinarymedicated feeds which require veterinary
oversight are VFDsoversight are VFDs
 In 2000 FDA finalized regulations for authorization,In 2000 FDA finalized regulations for authorization,
distribution and use of VFDsdistribution and use of VFDs
 Although a similar concept, (…Although a similar concept, (… by or on the orderby or on the order
of a licensed veterinarianof a licensed veterinarian) VFD) VFD drugsdrugs are not Rxare not Rx
drugsdrugs 24

25. Updates to VFD regulationUpdates to VFD regulation
 Changes intended to make process more efficientChanges intended to make process more efficient
while continuing to provide public healthwhile continuing to provide public health
protectionsprotections
 VFD Final RuleVFD Final Rule
 June 3, 2015 – VFD final rule publishedJune 3, 2015 – VFD final rule published
 October 1, 2015 – VFD final rule became effectiveOctober 1, 2015 – VFD final rule became effective
25

26. CurrentCurrent VFD DrugsVFD Drugs
26
Currently Approved VFD Drugs Approved for Use in the Following Species
Avilamycin Swine – reduction of diarrhea – E. coli.
Florfenicol Fish – control of mortality (various diseases by fish type)
Swine – control of SRD
Tilmicosin Cattle – control of BRD
Swine – control of SRD
Note: The three drugs above are affected by the VFD
regulation which went into effect 1 October 2015, because
they are currently approved as VFD drugs. The medically
important antimicrobials will be affected by the VFD Rule
when they transition from OTC to VFD beginning 1
January 2017. (See the next slide.)

27. Examples of medicated feed-use antibiotics that areExamples of medicated feed-use antibiotics that are
expected toexpected to be withdrawn orbe withdrawn or transitiontransition from OTCfrom OTC to VFDto VFD
statusstatus
27
Antimicrobial
Class
Specific drugs approved for use in feed
Aminoglycosides Apramycin, Neomycin, Streptomycin
Diaminopyrimidines Ormetoprim
Hygromycin B Hygromycin B
Lincosamides Lincomycin
Macrolides Erythromycin, Oleandomycin, Tylosin
Penicillins Penicillin - Currently only production uses.
Streptogramins Virginiamycin
Sulfas Sulfadimethoxine, Sulfamerazine,
Sulfamethazine, Sulfaquinoxaline
Tetracycline Chlortetracycline, Oxytetracycline

28. What are key elements of VFD regulation?What are key elements of VFD regulation?
28

29. InformationInformation RequiredRequired on theon the
Veterinary Feed DirectiveVeterinary Feed Directive
 The regulation lists all information that must beThe regulation lists all information that must be
included on the VFD in order for it to be lawfulincluded on the VFD in order for it to be lawful
 The veterinarian is responsible for making sure theThe veterinarian is responsible for making sure the
directive is complete and accuratedirective is complete and accurate
 See brochures for listing of required information:See brochures for listing of required information:
 Veterinary Feed Directive Producer RequirementsVeterinary Feed Directive Producer Requirements
 Veterinary Feed Directive Requirements for Distributors (Who Manufacture VFD Feed)Veterinary Feed Directive Requirements for Distributors (Who Manufacture VFD Feed)
 Veterinary Feed Directive Requirements for Distributors (Who Do Not Manufacture VFD Feed)Veterinary Feed Directive Requirements for Distributors (Who Do Not Manufacture VFD Feed)
 Veterinary Feed Directive Requirements for VeterinariansVeterinary Feed Directive Requirements for Veterinarians
 Veterinary Feed Directive Requirements for Veterinarians - For Veterinary StudentsVeterinary Feed Directive Requirements for Veterinarians - For Veterinary Students
29

30. VFD Final Rule: DistributorsVFD Final Rule: Distributors
 A ‘‘distributor’’ means any person who distributes a medicatedA ‘‘distributor’’ means any person who distributes a medicated
feed containing a VFD drug to another person.feed containing a VFD drug to another person.
 Such other person may be another distributor or the client-Such other person may be another distributor or the client-
recipient of the VFD medicated feed.recipient of the VFD medicated feed.
There are two kinds of distributors:There are two kinds of distributors:
1.1. Only distributes VFD feedOnly distributes VFD feed
2.2. Manufactures and distributes VFD FeedManufactures and distributes VFD Feed
 Distributors must notify FDA:Distributors must notify FDA:
 Prior to the first time they distribute animal feed containing a VFD drugPrior to the first time they distribute animal feed containing a VFD drug
 Within 30 days of any change of ownership, business name, or businessWithin 30 days of any change of ownership, business name, or business
addressaddress
30
To notify FDA, please contact:To notify FDA, please contact: FDA, Division of Animal FeedsFDA, Division of Animal Feeds
7519 Standish Place, HFV-2207519 Standish Place, HFV-220
Rockville, MD 20855Rockville, MD 20855
FAX: 240-453-6882FAX: 240-453-6882

31. VFD Final Rule: Drug CategoriesVFD Final Rule: Drug Categories
 Feed-use drugs are assigned to one of two categories:
 Category I - drugs having the lowest potential for
residues
 Category II - drugs having the highest potential for
residues
 Category determines whether a facility needs to be licensed to handle
the drug in the Type A form
 Definition of Category II has been revised to eliminate the automatic
classification of VFD drugs into Category II
 This change applies to the existing approved VFD drug products, in
addition to the products that will become VFD under GFI #213
31

32. VFD Expiration Date and Duration of UseVFD Expiration Date and Duration of Use
 VFD Expiration DateVFD Expiration Date ––
 Specifies the period of time for which the VFDSpecifies the period of time for which the VFD
authorization is validauthorization is valid
 A VFD feed should not be fed after the expirationA VFD feed should not be fed after the expiration
date (i.e., after VFD authorization expires)date (i.e., after VFD authorization expires)
 May be specified on the product label; if not – itMay be specified on the product label; if not – it
cannot exceed 6 months after the date of issuance.cannot exceed 6 months after the date of issuance.
 The veterinarian can use his or her medicalThe veterinarian can use his or her medical
judgment to determine whether a more limitedjudgment to determine whether a more limited
period is warrantedperiod is warranted
32

33. VFD Expiration Date and Duration of UseVFD Expiration Date and Duration of Use
 The Duration of Use –The Duration of Use –
 A separate concept from the expiration dateA separate concept from the expiration date
 The length of time that the animal feed containingThe length of time that the animal feed containing
the VFD drug is allowed to be fed to the animalsthe VFD drug is allowed to be fed to the animals
 Established as part of the approval, conditionalEstablished as part of the approval, conditional
approval, or index listing processapproval, or index listing process
 If the VFD order will expire before completing theIf the VFD order will expire before completing the
duration of use on the order, the client shouldduration of use on the order, the client should
contact his/her veterinarian to request a new VFDcontact his/her veterinarian to request a new VFD
orderorder
33

34. CurrentCurrent VFD DrugsVFD Drugs
34
Currently
Approved
VFD Drugs
Approved for the Following Uses –
(abbreviated indications)
VFD
Expiration
Date
Duration of
Use
Avilamycin Swine – reduction of diarrhea – E. coli. 90 d 21 d
Florfenicol Fish – control of mortality (various
diseases by fish type)
< 6 m 10 d
Swine – control of SRD 90 d 5 d
Tilmicosin Swine – control of SRD 90 d 21 d
Cattle – control of BRD 45 d 14 d

35. Medically important antibiotics used inMedically important antibiotics used in
animal feed expected to transition fromanimal feed expected to transition from
OTC to VFD marketing status.OTC to VFD marketing status.
 Expiration Date:Expiration Date: not to exceed 6not to exceed 6
monthsmonths
 Duration of Use:Duration of Use: See CVM Blue BirdSee CVM Blue Bird
Label websiteLabel website
 http://www.fda.gov/animalveterinary/products/animalfoodfeeds/m
edicatedfeed/bluebirdlabels/default.htm
35

36. RefillsRefills
 Refills (reorders) – Are only permitted to be issuedRefills (reorders) – Are only permitted to be issued
by veterinarians if the drug approval, conditionalby veterinarians if the drug approval, conditional
approval, or index listing expressly allows a refillapproval, or index listing expressly allows a refill
(or reorder)(or reorder)
 If a label is silent on refills, a refill may not be authorizedIf a label is silent on refills, a refill may not be authorized
 Currently, there are no approved VFD drugs that allowCurrently, there are no approved VFD drugs that allow
refills or reorders as a condition of their approval,refills or reorders as a condition of their approval,
conditional approval, or index listingconditional approval, or index listing
36

37. Approximate Number of AnimalsApproximate Number of Animals
 VFD must include anVFD must include an approximateapproximate number ofnumber of
animals:animals:
 The potential number of animals of the species andThe potential number of animals of the species and
production class identified on the VFD that will be fedproduction class identified on the VFD that will be fed
the VFD feed or combination VFD feed manufacturedthe VFD feed or combination VFD feed manufactured
according to the VFD at the specified premises by theaccording to the VFD at the specified premises by the
expiration date of the VFDexpiration date of the VFD
37

38. Approximate Number of AnimalsApproximate Number of Animals
 VFD will no longer be required to specify theVFD will no longer be required to specify the
amount of feed to be fedamount of feed to be fed
 Expectation is that feed mill will work with theExpectation is that feed mill will work with the
client and veterinarian to determine anclient and veterinarian to determine an
appropriate amount of feed to manufacture andappropriate amount of feed to manufacture and
distribute under the VFDdistribute under the VFD

based on the approximate number of animals,based on the approximate number of animals,
duration of use, and expiration dateduration of use, and expiration date
38

39. Combination VFD drugsCombination VFD drugs
 ““Combination VFD drug”Combination VFD drug” - (12) A ‘‘combination- (12) A ‘‘combination
veterinary feed directive (VFD) drug’’ is aveterinary feed directive (VFD) drug’’ is a
combination new animal drug … intended for use incombination new animal drug … intended for use in
or on animal feed which is limited by a [CVM]or on animal feed which is limited by a [CVM]
approved application … to use under theapproved application … to use under the
professional supervision of a licensed veterinarian,professional supervision of a licensed veterinarian,
and at least one of the new animal drugs in theand at least one of the new animal drugs in the
combination is a VFD drug.combination is a VFD drug.
 The new VFD rule requires the issuing veterinarian toThe new VFD rule requires the issuing veterinarian to
include one of three “include one of three “affirmation of intentaffirmation of intent””
statements to affirm his or her intent as to whether thestatements to affirm his or her intent as to whether the
VFD drug being authorized can or cannot be used inVFD drug being authorized can or cannot be used in
approved combinationsapproved combinations
39

40. CurrentCurrent VFD DrugsVFD Drugs
40
Currently
Approved
VFD Drugs
Approved for Use in the Following Species –
(abbreviated indications)
Combinations/
Affirmation
Avilamycin Swine – reduction of diarrhea – E. coli. None/
1
Florfenicol Fish – control of mortality (various diseases by
fish type)
None/
1
Swine – control of SRD None/
1
Tilmicosin Swine – control of SRD None/
1

41. CurrentCurrent VFD DrugsVFD Drugs
41
Currently
Approved
VFD Drug
Currently
Approved
Combination
Approved for Use in the Following
Species – (abbreviated indication)
Affirmation
Tilmicosin Tilmicosin
only
Cattle – control of BRD 1
+ Monensin Cattle – control of BRD + Coccidiosis 2 or 3
+ Monensin Cattle – control of BRD + Feed efficiency 2 or 3

42. Substitution of VFD drugsSubstitution of VFD drugs
Use of an approved generic VFD drug as a substituteUse of an approved generic VFD drug as a substitute
for an approved pioneer VFD drug in cases where thefor an approved pioneer VFD drug in cases where the
pioneer VFD drug is identified on the VFD.pioneer VFD drug is identified on the VFD.
If the veterinarian does not specify that a substitutionIf the veterinarian does not specify that a substitution
is not allowed, the feed manufacturer may use eitheris not allowed, the feed manufacturer may use either
the approved pioneer or an approved generic VFD drugthe approved pioneer or an approved generic VFD drug
to manufacture the VFD feed.to manufacture the VFD feed.
However, the feed manufacturer may not substitute aHowever, the feed manufacturer may not substitute a
generic VFD drug for a pioneer VFD drug in ageneric VFD drug for a pioneer VFD drug in a
combination VFD feed if the generic VFD drug is notcombination VFD feed if the generic VFD drug is not
part of an approved combination VFD drug.part of an approved combination VFD drug.
42

43. CurrentCurrent VFD DrugsVFD Drugs
43

44. Veterinary Client Patient Relationship (VCPR)Veterinary Client Patient Relationship (VCPR)
 Veterinarian issuing a VFD is required to beVeterinarian issuing a VFD is required to be
licensed to practice veterinary medicine andlicensed to practice veterinary medicine and
operate in compliance with either:operate in compliance with either:
 State-defined VCPRState-defined VCPR – if VCPR defined by such– if VCPR defined by such
State includes the key elements of a valid VCPRState includes the key elements of a valid VCPR
defined in § 530.3(i); ordefined in § 530.3(i); or
 Federally-defined VCPRFederally-defined VCPR - if a VCPR is not- if a VCPR is not
required to write a VFD in that state or the keyrequired to write a VFD in that state or the key
elements are not met.elements are not met.
44

45. Veterinary Client Patient Relationship (VCPR)Veterinary Client Patient Relationship (VCPR)
 The State-defined VCPR must at leastThe State-defined VCPR must at least
address the concepts that the veterinarian:address the concepts that the veterinarian:
1)1)engage with the client to assume responsibility forengage with the client to assume responsibility for
making clinical judgments about patient health;making clinical judgments about patient health;
2)2)have sufficient knowledge of the patient by virtue ofhave sufficient knowledge of the patient by virtue of
patient examination and/or visits to the facility wherepatient examination and/or visits to the facility where
patient is managed; andpatient is managed; and
3)3)provide for any necessary follow-up evaluation or careprovide for any necessary follow-up evaluation or care
45

46. Veterinary Client Patient Relationship (VCPR)
 FDA worked with State regulatory authorities
to verify whether that state has VCPR
requirements in place that:
 apply to the issuance of a VFD, and
 include the key elements of the federally-defined
VCPR
46

47. Veterinary Client Patient Relationship (VCPR)
 FDA has provided an online list of such
states on the VFD website
 This list will be updated periodically as FDA
receives and verifies information from states if they
change their VCPR definition or its applicability
 For the current list of state or federal VCPR see
http://www.fda.gov/animalveterinary/developme
ntapprovalprocess/ucm071807.htm
47

48. When will this go into effect?When will this go into effect?
48

49. Implementation Timeline SummaryImplementation Timeline Summary
 October 1, 2015October 1, 2015 – VFD Final Rule went into– VFD Final Rule went into
effecteffect
 Applies to current VFD drugsApplies to current VFD drugs
 January 1, 2017January 1, 2017 – Target for all medically– Target for all medically
important antimicrobials for use in or on feed toimportant antimicrobials for use in or on feed to
require a VFDrequire a VFD
 December 2016December 2016 – Target for drug sponsors to– Target for drug sponsors to
implement changes to use conditions of productsimplement changes to use conditions of products
affected by GFI #213affected by GFI #213
49

50. References and ResourcesReferences and Resources
 NOTE:NOTE:
 As the industry transitions, CVMAs the industry transitions, CVM
anticipates several changes during theanticipates several changes during the
coming months to the information in thiscoming months to the information in this
presentation, please check the followingpresentation, please check the following
links for the most recent updates.links for the most recent updates.
50

51. References and ResourcesReferences and Resources
 Veterinary Feed Directive,Veterinary Feed Directive,
http://www.fda.gov/AnimalVeterinary/DevelopmentApphttp://www.fda.gov/AnimalVeterinary/DevelopmentApp
rovalProcess/ucm071807.htmrovalProcess/ucm071807.htm
 Judicious Use,Judicious Use,
http://www.fda.gov/AnimalVeterinary/SafetyHealth/Antihttp://www.fda.gov/AnimalVeterinary/SafetyHealth/Anti
microbialResistance/JudiciousUseofAntimicrobials/defmicrobialResistance/JudiciousUseofAntimicrobials/def
ault.htmault.htm
 Blue Bird Labels,Blue Bird Labels,
http://www.fda.gov/AnimalVeterinary/Products/AnimalFood
Feeds/MedicatedFeed/BlueBirdLabels/default.htm
51

52. To Receive Information Updates
 Follow CVM on Twitter @FDAanimalhealth
 Subscribe to Animal & Veterinary Email Updates:
 What's New in Animal & Veterinary:
New items posted to the Animal & Veterinary section of FDA's website.
 CVM Updates:
Updates and news releases from FDA's Center for Veterinary Medicine
(CVM).
 CVM FR Notices:
Federal Register notices issued by the Center for Veterinary Medicine,
excluding drug approvals.
 What's New:
RSS Feed for new items posted to the Animal & Veterinary section of
FDA's website.
52

53. Thank YouThank You
53