Veterinary Feed Directive - PORK Academy - Dr. Chris Rademacher, Iowa State University, from the 2017 World Pork Expo, June 7 - 9, 2017, Des Moines, IA, USA. More presentations at http://www.swinecast.com/2017-world-pork-expo

1. VFD : What have we learned?
Chris J. Rademacher, DVM
Associate Clinical Professor
ISU Swine Extension Veterinarian
cjrdvm@iastate.edu
Twitter: @cjrdvm

2. Summary of FDA Guidance 209/213
1. Limits “medically important” antibiotics to therapeutic
purposes (to protect animal health and well-being).
– Therapeutic Purposes
• Treatment
• Control
• Prevention
2. Non-therapeutic uses of “medically important” antibiotics are
no longer permitted.
– Improved growth and feed conversion

3. Summary of FDA Guidance 209/213
3. Also states the importance of veterinary oversight into all on-
farm antibiotic decisions.
– Veterinary oversight will now guide all antibiotic decisions
on the farm.
• All “medically important” antibiotics used in mass medication
(feed/water) will have to be scripted (Rx) in their use.
– Eliminates “Over the Counter” usage of medically
important antibiotics used in mass medication (Feed and/or
Water).
• No longer be able to purchase “medically important”
antibiotics (feed/water) without a prescription (Rx) from a
licensed veterinarian.

4. • Antibiotics that are already VFD or Rx based:
– avilamycin, florfenicol, tilmicosin; or Rx - Tylosin.
• Antibiotics that are not medically important:
– Ionophores (monensin, lasalocid, narasin (Skycis,etc. )
– Bacitracin (BMD, bacitracin zinc)
– Bambermycins (Flavomycin)
– Carbadox (Mecadox)
– Tiamulin (Denagard)
• Other drugs (that are not antibiotics), including:
– Anthelmentics: Coumaphos, Fenbendazole, Ivermectin
– Beta agonists: Ractopamine, Zilpaterol
– Coccidiostats: Clopidol, Decoquinate, Diclazuril
Antibiotics NOT affected by Guidance 209/213

5. Producer Responsibilities
• Establish VCPR with your veterinarian
• Ensure VFD is valid
• Retain VFD copy for 2 years

6. What have we seen in terms of usage?
• Many producers have migrated their medically
important antibiotics to non-medically important
options.
– Need to ensure that they are still getting demonstrable
efficacy.
• Some have eliminated use of antibiotics for growth
promotion altogether.

7. FeedLINK® VFD production
0
10000
20000
30000
40000
50000
60000
2013 2014 2015 2016* Effective 2017
Annual VFD levels compared to VFDs effective
January 2017
Other
Bovine
Swine
FeedLINK approximately

8. 2017 FeedLINK® VFDs by
Species
Swine
36%
Bovine
62%
Ovine
1%
Poultry
1%
Other
0%
1,204 clinics
2,317 veterinarians

9. Average number head per VFD
7165
1152
699
0
1000
2000
3000
4000
5000
6000
7000
8000
Swine Bovine Ovine
Poultry
4,512,954
Aquaculture
320,362
Bees
20,166,756

10. # Swine VFDs sorted by number head
8046
5479
2083
1566
984
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
< 2000 2000-4999 5000-9999 10000-24999 >25000
898 veterinarians have generated
FeedLINK VFD’s for swine in 2017
75%
Range: 1 – 200,000 pigs

11. Swine VFDs by Active Ingredient
Chlortetracycline
56%
Lincomycin
11%
Tylosin
11%
Tilmicosin
8%
Other
14%

12. Swine Headcount by Active Ingredient
Chlortetracycline
60%
Lincomycin
11%
Oxytetracycline
10%
Tylosin
5%
Other
14%

13. Who is responsible for monitoring the appropriate
amount of feed issued under a VFD?
A. The distributor and client share
responsibility for monitoring the amount of
feed issued to fill a VFD. The client taking care
of the animals should know their size and
consumption rate and should share this
information with the distributor to order an
appropriate amount of feed. Quantities should
be commensurate* with the approximate
number of animals.
*corresponding in size or degree; in proportion.

14. For a medication that will be split into pelleted feed from one feed
distributor followed by mash feed from a different (business entity) feed
distributor, does it require 2 separate VFDs?
In situations where it has been predetermined that the
VFD feed will come from two different distributors
during the VFD duration period, the veterinarian
should indicate in the special instructions the
distributor of the VFD feed for each portion of the
treatment period. Both distributors should receive
copies of the VFD. Each distributor should only
provide an amount of feed that is commensurate with
the approximate number of animals and the portion of
the treatment period for which the distributor is
responsible for distributing the VFD feed.
https://www.ipic.iastate.edu/info/VFDfaq.pdf

15. VFD Special Instructions Section
Section of the VFD to
put additional
information regarding
the VFD and
corresponding feed
orders.
Courtesy of Zoetis Animal Health

16. VFD Special Instructions Section
Section of the VFD to
put additional
information regarding
the VFD and
corresponding feed
orders.
Courtesy of Global Vet Link

17. Other things to put in “Special Instructions”
• If you are writing a VFD for a “flow” or “production” situation;
please state in SPECIAL INSTRUCTIONS, approximate number
of animals per group, frequency of the group arrivals and
approximate average weight of the animals.
– For example: 1000 head entering the facility approximately every 8 weeks,
weighing approximately 12 pounds per head.
• These special instructions will ultimately help the distributor,
the client and the inspector, when using and reviewing the
issued VFD.
Courtesy of Mr. Jeff Verzal, IDALS

18. Other things to put in “Special Instructions”
• If a VFD states a “duration of feeding” or “feeding
interval” (i.e. 5 days, 14 days), remind the client or
even write in the SPECIAL INSTRUCTIONS section,
“this directive is to be used only once per group
only”.
Courtesy of Mr. Jeff Verzal, IDALS

19. What about “Pulse Dosing”?
Pulse dosing
• Defined as using the same antibiotic on the same group of
animals at 2 different times
– Refill?
– Treatment failure?
• Current recommendation from FDA-CVM
– Write 2 different VFD’s
• One for each pulse.
• Veterinary documentation on why you need the second pulse.

20. How close does the client have to be to the intended
duration of feeding (number of days fed)?
• VERY CLOSE
– Must be fed according to the duration listed on the
label
• Aureo: “For not more than 14 days”
• Pulmotil: “shall not be fed to pigs for more than 21 days
• Linco/Tylan: “..feed for disease X for 21 days at 100
grams and then at 40 grams to market….”
– Regulator comments indicate they expect it to be
close to duration stated on VFD (i.e. within 1-2 days)

21. Are contract growers (doesn’t own the pigs and the owner of the pigs are listed
as the client) required to have a copy of the VFD on-site?
The regulation requires the veterinarian to provide the VFD to the client.
The veterinarian can meet that obligation by providing a copy to the client.
One client could have a number of locations covered by one VFD. It is
acceptable for the VFD to be stored in one location; however, if the client is
not directly feeding the animals at each location (e.g., an employee is),
then the VFD should be made available to those responsible for the direct
care of the animals so that they can feed the VFD feed in accordance with
the VFD as required by the VFD rule. This may be done by having a physical
copy of the VFD at each location, or it may be done by providing electronic
access to the VFD that is stored in a central location. Either way, the client
is required to have a copy of the VFD, so when an inspector requests a copy
during an inspection the location either needs to be in possession of that
VFD, or have a way to access the VFD order.

22. What if the contract grower was listed as the client/caretaker on the VFD?
The preamble to the final rule (21 CFR 558.6) and the definition for a veterinary feed directive
describe the client as the "owner of the animals or other caretaker." Response 26 in the
preamble states that 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 the situation described, for the purposes of the VCPR and VFD it you have stated that the
Contractor is the client on the VFD order. Therefore, the Contractor (as defined in # 4) would
be required to have a copy of the VFD. This may be done by having a physical copy of the VFD
at the location, or it may be done by providing electronic access to the VFD that is stored in
a central location. Either way, the client is required to have a copy of the VFD, so when an
inspector requests a copy during an inspection the location either needs to be in possession
of that VFD, or have a way to access the VFD order. The rule does not preclude the owner of
the animals from also having a copy of the VFD if that would be useful for business purposes.

23. Potential Inspection Questions
• Only a handful so far that I am aware of.
• Questions specific to producers/clients:
– Does the client keep copies of VFD orders for at least 2 years?
– Did the client feed the VFD feed to the authorized number of animals
on the VFD order?
– Did the client feed the VFD feed for the identified duration on the VFD
order?
– Did the client stop feeding the VFD feed prior to the expiration date on
the VFD order?
– Did the client follow the withdrawal period for the VFD feed, if any?

24. What about indications for use?
• FDA-CVM has repeatedly said that the inspectors are
not in the practice of veterinary medicine.
– Need good veterinary documentation and good evidence
of VCPR.
– Veterinarians may choose to start doing diagnostics to help
provide documentation to support recommendations
• Prevention and Control

25. 58
87 81
65 73 72 73
56
33
66
1.5
0.0 4.9
1.5
2.4 1.1
16.7
0.6
11.1
3.4
39
11 14
34 22 25
9
43
44
29
2.2 2.2 0.0 0.0 2.7 1.1 1.0 0.6 11.1 1.4
0
10
20
30
40
50
60
70
80
90
100
%,SignificantADGresponse
(0) (-) (+) nr
What about antibiotic
alternatives?
• Searched scientific
publication databases
• Included articles since
1990
• Had to evaluate
production
parameters
• ADG or Mortality
Schweer, Olson, Gabler et al, ISU
Be very wary of antibiotic alternatives
without rigorous scientifically tested

26. Prevention and Duration
• Use of antibiotics to
prevent disease under
fire
• FDA Duration of Use
– Position as a way to
defend prevention
Courtesy Dr. Liz Wagstrom

27. So what is coming at us next?
• Several states are in the process of passing laws
against “routine use of antibiotics for prevention”.
– California
– Maryland
– Oregon (under consideration)
• Would need veterinary justification and only in
special, documentable circumstances.

28. Resources
• Iowa Pork Industry Center
– https://www.ipic.iastate.edu/
• Go to Diseases and Health tab
• FDA website
– Questions: AskCVM@fda.hhs.gov
• Veterinary and industry trade associations
– Pork.org/antibiotics resource center
• GlobalVetLINK website
– VFD, Script and OTC drug list
– Paper vs electronic VFD process
– Questions: info@globalvetlink.com

29. Questions??
Chris J. Rademacher, DVM| Swine Extension Veterinarian
Iowa State University2225 Lloyd Veterinary Medical Center | Ames, IA 50011
(: (515) 294-8792 | *: cjrdvm@iastate.edu
Follow on Twitter: @cjrdvm
www.ipic.iastate.edu