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VETERINARY
FEED
DIRECTIVE
Barry Whitworth, DVM
Area Food/Animal Quality and
Health Specialist for Eastern Oklahoma
FDA TASK FORCE REPORT
“THE USE OF ANTIBIOTICS IN
ANIMAL FEED”
• Associated with the development of resistant
bacteria
• Serve as reservoir of antimicrobial-resistant
pathogens
• Prohibited for growth promotion
• By a veterinarian or on a veterinarian
prescription
• 1970
REFERENCES
• FDA Website Veterinary Feed Directive
• 21 Code of Federal Regulation 558 and 530
• Guidance for Industry #120, 152, 209, 213
• Lecture Doug Hufstedle Elanco
• Webinar Elanco
• Webinar Zoetis
• Stewardship of Antimicrobials Workshop:
Amarillo
GOAL OF THE
PRESENTATION
• History
• Define VFD
• What OTC drugs will be affected by the change in
status
• Time frame of implementation
• Producer requirements
• Not going to Debate the change in status of the OTC
drugs
BEFORE 1996, THERE
WERE TWO OPTIONS FOR
DISPENSING NEW ANIMAL
DRUGS:
•Over-The-Counter (OTC)
•Prescription (Rx)
WHY NOT LABEL THE
DRUG A PRESCRIPTION
DRUG?
• Did Not Want to Invoke State Pharmacy
Laws for Prescription Drugs
(Impractical to use the drug)
ANIMAL DRUG
AVAILABILITY ACT
1996
Congress created a new category of
drugs call Veterinary Feed Directive
(VFD) drugs.
Final rule Federal Register of
December 8, 2000 (21CFR 558)
Effective January 1, 2001
OCTOBER 1, 2015
• Minor changes to the original VFD rule (21
CFR 558.6) went into effect
GUIDANCE FOR INDUSTRY #209
APRIL 13, 2012
“THE JUDICIOUS USE OF MEDICALLY
IMPORTANT ANTIMICROBIAL DRUGS IN FOODPRODUCING ANIMALS”
• Executive Summary
• Limiting medically important antimicrobial drugs (drugs
that are important for therapeutic use in humans GFI#152) to
uses in food-producing animals that are considered necessary
for assuring animal health (use for treatment, prevention, and
control of disease and not for growth promotion or improved
feed efficiency)
• Limiting such drugs to uses in food-producing animals that
include veterinary oversight or consultation (this changes
OTC drugs to VFD or Prescription drugs)
UNDER THE GUIDANCE
FOR INDUSTRY #209
• Drugs administered in or on feed will
switch from OTC to VFD drugs
• Drugs administered in water will switch
from OTC to Prescription (Rx) drugs
JANUARY 1, 2017
• The date that the OTC drugs will change
status to VFD drugs or Prescription drugs
VETERINARY FEED
DIRECTIVE (VFD)
•Two Meanings
• Document or Order
• Drug
VETERINARY FEED
DIRECTIVE (VFD) (GFI#120)
• A written (nonverbal) statement issued by a licensed
veterinarian in the course of the veterinarian’s
professional practice that orders the use of a VFD drug or
combination VFD drug in or on animal feed.
• This written statement authorizes the client (the owner
of the animal or animals or other caretaker) to obtain
and use animal feed bearing or containing a VFD drug or
combination VFD drug to treat the client’s animals only
in accordance with the conditions for use approved,
conditionally approved, or indexed by the FDA.
WHAT IS A VFD DRUG?
(GFI#120)
• A drug intended for use in or on animal
feed that is limited to use under the
professional supervision of a licensed
veterinarian.
WHAT IS THE
“PROFESSIONAL
SUPERVISIONS OF A
LICENSED
VETERINARIAN”?
• Licensed in the state of Oklahoma
• Working with producers within a
Veterinary-Client-Patient-Relationship
VETERINARIAN-CLIENTPATIENT-RELATIONSHIP
ANIMAL DRUGS EXPECTED
TO BE VFD DRUGS
• Apramycin
• Oleandomycin
• Avilamycin (already VFD)
• Oxytetracycline
• Chlortetracycline
• Penicillin
• Erythromycin
• Sulfadimethoxine:Ormetoprim
• Florfenicol (already VFD)
• Tilmicosin (already VFD)
• Hygromycin B
• Tylosin
• Lincomycin
• Sulfamerazine
• Neomycin
• Sulfamethazine
• Virginiamycin
ANIMAL DRUGS THAT
WILL REMAIN OTC
• Ionophores
• Coccidiostats
• Bacitracin
• Bambermycin
• Carbadox
• Pleuromutilin
REQUIRED
INFORMATION
FOR A LAWFUL
VFD
NAME, ADDRESS, PHONE
NUMBER
• Veterinarian and Producers
PREMISES AT WHICH
THE ANIMALS ARE
LOCATED
• Needs to be specific enough for
someone to be able to find the
animals
• May be different than the Client’s
address
DATE ISSUANCE
• The date the veterinarian writes the VFD
“EXPIRATION DATE”
• “Expiration Date” specifies the last date the
VFD feed can be fed (If not specified on the
label, the veterinarian sets the date which
cannot exceed 6 months)
DRUG, DRUG LEVEL,
“DURATION OF USE”
• The name of the drug to be used
• The amount of drug that is to be added to
the feed (grams/ton)
• This determines the length of time that the
animal feed containing a VFD drug is
allowed to be fed to the animals.
“EXPIRATION DATE” VS
“DURATION OF USE”
• Example: Tilmicosin “expiration date” is 45
days and “duration of use” is 14 days
• This means the producers after the issuance
of the VFD has 45 days to obtain the VFD
feed and complete the 14 days the therapy
MAY I FEED PAST THE
EXPIRATION DATE ?
• NO! VFD feeds may not be fed after
“expiration date”
• What should I do if I have not completed the
“duration of use” before the “expiration
date”?
• Obtain a new VFD from your veterinarian
SPECIES AND PRODUCTION
CLASS AND APPROXIMATE
NUMBERS
INDICATION
• What is the reason for using this drug?
• The condition must be on the label
WITHDRAWAL TIME
• Number of days before animal may be
slaughtered
• Other special instructions
• Cautions
REORDERS (REFILLS)
• If the drug approval, conditional approval,
index expressly allows a reorder (refill) a
veterinarian can authorize up to the
permitted number of reorders. If a drug is
silent on reorders (refills), then a
veterinarian may not authorize a reorder
(refill).
WHAT IS A COMBINATION
VFD DRUG ?
• An approved combination of new animal
drugs intended for use in or on animal feed
under the professional supervision of a
licensed veterinarian, and at least one of
the new animal drugs in the combination is
a VFD drug.
COMBINATION
VFD DRUG
EXTRA-LABEL USE
• “Extra-label Use” is defined in FDA’s regulations
as actual or intended use of a drug in an animal
in a manner that is not in accordance with the
approved labeling.
• “Extra-label Use” of VFD feed (or any other
medicated feed) is not permitted!
“PIONEER” AND
“GENERIC”
• Unless forbidden by the veterinarian a
“generic” drug may be substituted for the
“pioneer” drug
• However, not all “generic” drugs have the
same label claims as the “pioneer” drugs
RECORDS
• The veterinarian, distributor, and client
copies must be kept for 2 years and may be
kept as an electronic copy or hardcopy.
• All involved parties must make the VFD
available for inspection and copying by FDA
upon request.
WHAT SHOULD
PRODUCERS DO?
• Make sure that you have a good
relationship with a veterinarian
WHAT SHOULD
PRODUCERS DO?
• Take an inventory of what drugs you
currently using
WHAT SHOULD
PRODUCERS DO?
• Take list and go visit your
Veterinarian and Feed Store
WHAT SHOULD
PRODUCERS DO?
• “If you have to treat a disease with
antibiotic you have failed”
• Are there alternatives to antibiotics?
PRODUCER’S
RESPONSIBILITIES
• Feed according to the label
• Do not feed after expiration date
• Provide a copy of the VFD order to the feed
distributor if the issuing veterinarian sends the
feed distributor’s copy with you
• Maintain a copy of the VFD order for 2 years and
provide VFD orders for inspections and copying
by FDA upon request
DISTRIBUTOR’S
RESPONSIBILITIES
• “One-Time” Distributor Notification to FDA
• Only fill a VFD order if it contains all the
information
• Display label were it is easily seen
DISTRIBUTOR’S
RESPONSIBILITIES (CONTINUED)
• Acknowledgement letter between
distributors
• Keep VFD order and Acknowledgement
letters for 2 years
• Keep VFD manufacturing label for 1 year
QUESTIONS?