Discussion on the Veterinary Feed Directive Integration in Small Ruminant - Dr. Eric Gordon, The Ohio State University, from the 2017 NIAA Annual Conference, U.S. Animal Agriculture's Future Role In World Food Production - Obstacles & Opportunities, April 4 - 6, Columbus, OH, USA. More presentations at http://www.trufflemedia.com/agmedia/conference/2017_niaa_us_animal_ag_future_role_world_food_production

1. Eric D. Gordon DVM, DACVPM
Veterinary Feed Directive
- For Minor Species-

2. VFD
 Not a new concept – created in 1996
 Not a “prescription” because in most state
pharmacy laws a prescription requires a
pharmacist to dispense and feed mills do
not have pharmacists on staff

3. What is a VFD
 A written statement issued by a licensed
veterinarian that authorizes the use of a
VFD drug or combination VFD drug in or
on animal feed
 Rx – allows client to purchase Rx
medications and use them according to
directions
 VFD – allows client to feed the product
during a defined time period

4. Guidance #209 Principals
 Limit medically important drugs in feed to
uses in animals that are considered
necessary for ensuring animal health
Judicious use = treatment, prevention and
control
Production claims (feed efficiency and
growth promotion not allowed)

5. Guidance #209 Principals
 The use of medically important
antimicrobials in feed will require
veterinary oversight
FDA further defined this oversight in the
final regulation as a VCPR (Veterinary
Client Patient Relationship)

6. What Products
 Medically important products
Chlortetracycline/Oxytetracycline
Tylosin
Neomycin, Streptomycin
Sulfas
 Ionophores, bambermycins, vitamins,
minerals, not affected
 Injectables – not affected
 Water soluble products – affected
Will be Prescription (Rx)

7. Drugs Transitioning from OTC to VFD
Established drug name Examples of proprietary drug name(s)
chlortetracycline (CTC)
Aureomycin, CLTC, CTC, Chloratet, Chlorachel,
ChlorMax, Chlortetracycline, Deracin, Inchlor,
Pennchlor, Pfichlor
chlortetracycline/sulfamethazine* Aureo S, Aureomix S, Pennchlor S
chlortetracycline/sulfamethazine/penicillin*
Aureomix 500, Chlorachel/Pficlor SP, Pennchlor SP,
ChlorMax SP
hygromycin B Hygromix
lincomycin Lincomix
oxytetracycline (OTC) TM, OXTC, Oxytetracycline, Pennox, Terramycin
oxytetracycline/neomycin* Neo-Oxy, Neo-Terramycin
penicillin+ Penicillin, Penicillin G Procaine
sulfadimethoxine/ormetoprim* Rofenaid, Romet
tylosin Tylan, Tylosin, Tylovet
tylosin/sulfamethazine*
Tylan Sulfa G, Tylan Plus Sulfa G, Tylosin Plus
Sulfamethazine
virginiamycin Stafac, Virginiamycin, V-Max

8. Injectable Products
Still available OTC………FOR NOW

9. Water Soluble Products
WILL REQUIRE A PRESCRIPTION FROM A VETERINARIAN

10. Feed Grade Products

11. Veterinary Oversight
 FDA has stated the guiding principal for
veterinary oversight involves the VCPR
Veterinary Client Patient Relationship
 Oversight is the responsibility of the
veterinarian
 FDA has published which states have a
VCPR that satisfies the federal
requirements

12. VCPR (Veterinarian-Client Patient Relationship)
 AABP guidelines suggest a written
agreement
 The VCPR is a relationship between the
veterinarian, client/managers and patients
(cattle)
 It is not a police force……veterinarians
are here to help clients and animals

13. VCPR
 Ohio Revised Code – 4741.04
 A VCPR relationship serves as the basis
for interaction between veterinarians, their
clients, and their patients. A VCPR exists
when all of the following conditions have
been met:

14. VCPR
 (A) A veterinarian assumes responsibility
for making clinical judgements regarding
the health of a patient and the need for
medical treatment, medical services, or
both for the patient, and the client has
agreed to follow the veterinarians
instructions regarding the patient.

15. VCPR
 (B) The veterinarian has sufficient knowledge
of the patient to initiate at least a general or
preliminary diagnosis of the medical condition
of the patient. In order to demonstrate that the
veterinarian has sufficient knowledge, the
veterinarian shall have seen the patient
recently and also shall be acquainted
personally with the record keeping and care of
the patient either by examining the patient or by
making medically appropriate and timely visits
to the premises where the patient is kept.

16. VCPR
 (C) The veterinarian is readily available
for a follow-up evaluation, or has arranged
for emergency coverage, in the event the
patient suffers adverse reactions to the
treatment regimen or the treatment
regimen fails.

17. VFD Requirements for
Veterinarian
 Licensed in state
 Have a VCPR
 Fill out VFD correctly
 Keep records for TWO years in the
manner it was submitted (electronic or
paper)
 Client and distributor also keep copies

18. Types of VFD Drugs
 Type A = most concentrated form of the
drug and used to manufacture Type B & C
Must be a licensed feed mill to
manufacture feed with Type A Category II
drugs
One time registration with FDA
 Type B = contains a substantial quantity of
other nutrients with the Type A drug
 Type C = intended as complete feed or is
added on top of or as a supplement with
other animal feed

19. Distributors
 A distributor is any person who mixes and
distributes a VFD containing feed
Must notify FDA you are a distributor of
VFD feeds
Record keeping requirements

20. Record Keeping
Requirements
 Rules have changed….
 Original VFD must be kept by veterinarian
in the manner in which it was
submitted for 2 years
 Copy of VFD kept by distributor and client
for 2 years
Can be electronic or hard copy

21. VFD requirements
 Veterinary license not required
 Name of drug…..manufacturer can
substitute generic unless veterinary
specifies must be pioneer drug
 Dose of drug (g/ton) and indication
 Client name and address
 Location of animals (address, pen, barn,
coordinates)
 Statement that ELDU is not allowed

22. VFD Dates & Definitions
 A VFD from a licensed veterinarian with a
valid VCPR authorizes a client to feed
VFD feed to clients animals
 Expiration date of VFD is length of time
the authorization is legal
 Duration is the amount of time the
specified animals can be fed the VFD feed

23. Expiration Date
 Expiration date is the time frame for which
the VFD feed must be fed to the animals
 This is stated on the label or if not on the
label the maximum amount of time is six
months
 This is not duration which is on the
label and must always be followed

24. Minor Species
 Animals other than:
- cattle
- horses
- swine
- chickens
- turkeys
- dogs
- cats
Minor Species Examples:
Sheep
Goats
Catfish
Game birds
Honey bees

25. Minor Species
 As of November 2016 – Minor Species
(sheep, goats, game birds, etc.) are
subject to the same rules and guidelines
as major species.
 FDA considered allowing ELDU for minor
species

26. Minor Species – Rule Revision
 December 2, 2016
 FDA releases a Compliance Policy Guide
Section 615.115
 Allows for “extra-label” use in minor species
-sort of-

27. Minor Species
 Currently only a few approved VFD drugs
for sheep
- Aureomycin® – to treat Vibrionic
abortion in ewes
(80g/head/day)
- Neomycin + Oxytetracycline
for E. coli diarrhea and
respiratory disease
 NO VFD PRODUCTS APPROVED FOR
GOATS!

28. Extra-label Use
 May be considered for treatment of minor
species when there are no approved
treatment options available…
 And, the health of the animal is
threatened…
 And, suffering or death would result from
failure to treat the affected animal.

29. When is Extra-label Allowed?
 Have a valid VCPR
 Limit the extra-label use to:
- minor species not on the drug label…
- or, the use indication for that minor
species not listed on the label
 Medication has to be approved for use in animal
feed
 Use in a minor species similar to the species for
which the medication is approved

30. Extra-label Considerations
 Aquaculture is limited to medicated feeds
approved for use in aquatic species
 Avian species are limited to medicated
feeds approved for use in avian species
 Mammalian species are limited to
medicated feeds approved for use in
mammalian species

31. What can’t be done
 NO production (claim) purposes – must be
therapeutic
 No advertising of the medicated feed for
an extra-label use

32. Minor Species VFD
 Complete a separate written
recommendation to the client including the
medical rationale and the withdrawal
period with copies maintained by the
veterinarian and the client for 2 years.

33. Minor Species VFD
 Complete a VFD consistent with the approved
labeling for the indication (for a major species
and indication) and in “special instructions”,
note:
1.) “This VFD is being issued in accordance with
CPG 615.115”
2.) The actual species for which the medicated
feed is intended
3.) The withdrawal time associated with the
extra-label use if different from the labeled
withdrawal

34. Minor Species - Examples
 Can still use Sulfadimethoxine
(DeMethox®) – in water to treat coccidia –
WILL REQUIRE PRESCRIPTION
 Can still use Bovatech®, Rumensin®,
Corrid®, Deccox®
 Can still use all anthelmintics (dewormers)
and vaccines

35. Steps to a VFD
 1.) Contact your vet – with whom you have a VCPR
 2.) The vet will determine if the condition warrants a
VFD drug or feed
 3.) If warranted, the vet will issue a written and signed
VFD order – verbal orders are not allowed
 4.) The vet retains a copy and give the original to the
client
 5.) The client keeps a copy and gives the original to the
feed mill/distributor supplying the VFD feed (copies kept
for 2 years)
 6.) Separate VFD’s may be required for different groups
of livestock

36. Plan Ahead
 Review products you are using or
anticipate using with your veterinarian of
record…are they necessary?
 Ensure have a VCPR – written?
 Read labels for indication, dose, duration
 NO EXTRA LABEL DRUG USE ALLOWED
 Be aware of combinations and disclose all feed
products to veterinarian

37. Plan Ahead
 Ask your producers what products they
are using currently and review your VCPR
 DO NOT USE ANY FEED GRADE
DRUGS EXTRA LABEL
 Why are you using the product? Is it
necessary? Is it effective? Is it legal?
 Be aware of all combination drugs in feed
 Prepare to store VFD’s
 Prepare for establishing VCPR for
nonclients

38. Questions?
Eric D. Gordon
937-642-2936
gordon.46@osu.edu