1. VFD Q & A / Discussion Session
Dr. John Hallberg – Zoetis Regulatory Affairs
Dr. Michael Murphy – FDA Veterinary Officer
Dr. Charlie Hatcher – State Veterinarian
Dr. Lew Strickland – Extension Veterinarian
Dr. Mandy Willis – TVMA Large Animal Council Chair

2. NEW VFD FORM (TOP HALF)
Industry standard developed by AHI working group
Update of current VFD standard to reflect new requirements
No electronic requirement
Electronic applications must meet federal code for secure data storage 21 CFR Part 11
Location requirements still TBD
Distributor requirement

3. NEW VFD FORM (BOTTOM HALF)

4. NEW VFD FORM (TOP HALF)

5. NEW VFD FORM (BOTTOM HALF)

6. Q & A From Webinar – VFD Forms
Will you go into more detail about the affirmation of intent section and which box to check?
Is there one that involves less liability for the veterinarian?
The AS 700 form has g/ton blank. Are we the ones who will calculate that? Will you go through an example of how to calculate?

7. Q & A From Webinar
Does the producer order the medicated feed through the veterinarian or through the feed mill?  In other words, is it going to be like a PetMeds, where the feed mill calls and asks for the VFD or does the veterinarian have to contact the feed mill, or does the owner have to contact both individually?
Does the producer need to have a new VFD if they have left over product that is not currently being fed?  That is, if they have a bag of medicated feed or two left from a prior VFD that wasn't used and they are not currently feeding it, do they have to have a current VFD just to have it on the premises?

8. Q & A From Webinar
Is there a label (as with our injectable antibiotics) to be placed on the feed antibiotics with veterinarian's name,etc. ?
Does the producer have to present a document,etc. to the feed store at the time he wishes to purchase an antibiotic feed additive?  Does the veterinarian provide the producer a special form or document each time a purchase is made?
VFD caution statement on feed additive is feed company's responsibility?
In regards to an SOP for writing VFDs, do you think the industry, organizations will supply samples?

9. Veterinary Client Patient Relationship (VCPR) – Veterinarian Obligation
The VCPR is a relationship not a mandate. 
AMDUCA is purposefully ambiguous and does not regulate the practice of veterinary medicine.  That is up to state boards. 
The VCPR should not be utilized just to obtain VFD and Rx meds. 
That is a service that can be provided once you have a VCPR. 
Many times veterinarians can decrease farm costs by having a consultative VCPR. 
I think a farm visit, familiarity with the animals. the role of the veterinarian and farm management, the services offered, protocols and treatment records are all part of establishing and maintaining a VCPR. 
A once a year drive by visit is not a VCPR. 
Time frames are farm specific. 
Professional judgment for each farm (all farms different)
A 100,000 head feedlot vs a 3000 cow dairy vs a 20 head cow-calf operation require different levels of oversight, however it should be the VETERINARIAN that determines what level satisfies the VCPR, not the producer.

10. Veterinary Client Patient Relationship (VCPR) – Veterinarian Obligation
Assumes responsibility for making clinical judgments about the health of the patient/herd
Sufficient knowledge of the patient and management
Readily available for follow-up and emergencies (in adverse rxn)
Recently Seen patients
Personally acquainted and Familiar with animals and operation
Perform examination of animals
Medically Appropriate & Timely visits to the premises
Guidelines or Rules have not been set because every farm operation and management is so different

11. Veterinary Client Patient Relationship (VCPR) – Veterinarian Obligation

12. Q & A From Webinar - VCPR
Does the FDA expect a veterinarian to visit the farm every 6 months if writing VFDs for that farm?
VCPR - What kind of documentation?
How long does it last for each VFD?  (same as the VFD?)
Others?

13. FDA Inspections – What to Expect
DVM Inspection Questions:
Is the DVM licensed in the states VFD is being fed?
Does the DVM know the VCPR requirements in their state and or federal requirements and can they demonstrate proper VCPR with the location getting medicated feed?
Can the veterinarian show any medical record(s) for the client’s animals named on the VFD?
Does the veterinarian keep copies of the VCPR as required by regulation.
For a Time Period the FDA will be Educating, then they will switch to Regulating

14. Q & A From Webinar - Inspections
Experiences with FDA Inspections?
Any Questions?

15. Specific Case Discussion
Medically Important Antibiotics (MIAs)
Medicated Feeds (VFD Required)
Chlortetracycline
Oxytetracycline
Sulfa’s
Tylosin
Others?
Water Soluable (Rx Required)
Chlortetracycline, Sulfa’s,
Non Medically Important (VFD Not Required if fed w/o MIA)
Ionophores - monensin, lasalocid
Coccidiostats - Clopidol, Decoquinate, Diclazuril, Amprolium

16. Specific Case Discussion Tetracyclines - Products
Chlortetracycline
Aureomycin, CTC, Chloromax, Pennchlor, ChlorMax, Aureozol, CLTC, Pfichlor, CSP, *AureoS 700, *Amp Ethopabate CTC® Sodium Sulfate, ChlorMax/Deccox, Coyden 25/CTC,,
Oxytetracycline
TM-5, Terramycin Egg Formula, TM-10 Premix, *MGA (dry or liquid)/Terramycin,
Water Soluable Chlortetracycline/Oxytetracycline
Magna Terramycin® Soluble Powder, Medamycin Soluble Antibiotic  OXY WS™ Soluble Antibiotic,
*Chlortetracycline + Sulfamethazine &/or other Drugs Added

17. Specific Case Discussion Tetracyclines – Product Approvals

18. Specific Case Discussion Tetracyclines – Label Indications
Pneumonia (BRD) – Cattle
High Risk calves, In respiratory outbreak, etc.
Anaplasmosis - Cattle
When can we prescribe for this?
Medical determination with presumptive diagnosis-document why you made presumptive diagnosis
FDA not worried about second guessing a diagnosis
Contact state lab about #cases-they do not keep up with this because it is not a reportable disease

19. NEW VFD FORM (TOP HALF)
Industry standard developed by AHI working group
Update of current VFD standard to reflect new requirements
No electronic requirement
Electronic applications must meet federal code for secure data storage 21 CFR Part 11
Location requirements still TBD
Distributor requirement

20. ZOETIS PRODUCTS THAT WILL REQUIRE A VFD
*Combinations using any of these products also require a VFD.

21. Specific Case Discussion Tetracyclines – Label Indications
Campylobacter Abortions - Sheep
No for goats – No VFD Indications for Goats
The FDA knows this is an issue – trying to come up with solutions
Footrot – No VFD label claims
DI-METHOX® SOLUBLE POWDER AgriLabs – Water Soluable Product
Other ways to handle foot rot?
Feed grade Iodine?
Bacterial enteritis – but not a valid reason for prescription?
Rare to be bacterial
Research against the efficacy of this product
Other things a lot more important –fluids etc.

22. Specific Case Discussion Tetracyclines – Label Indications
Chickens, Turkeys, Swine, Bees, Small Ruminants – these people don’t normally use a veterinarian so may run into some of this and need to have a plan of how you will handle these
Resource to go to:
AVMA resource page - Backyard chickens 101
Veterinary Information Network VIN
State Vet
Specific Food Animal Vets in Area (Swine, Poultry, Small Ruminants)
Bees – resource on TVMA resource pg
Sheep & Goats (minor use/minor species animal health act of 2004?)
noruseminorspecies/default.htm
AASRP
VIN
Pugh’s Sheep & Goat book
FARAD
Specific Food Animal Vets in Area (Swine, Poultry, Small Ruminants)
Small Ruminants
Dr. David Pugh, Dr. Christine Navarre, Dr. Virginia Fajt (SR Pharmacology Expert)
Swine
Dr. Rick Tubbs

23. Specific Case Discussion Sulfas - Products
Sulfadimethoxine
Sulfamerazine
Sulfamethazine
Sulfaquinoxaline
Medicated Feeds (VFD)
Rofenaid, Sulfamerazine, Tylan Sulfa-G
Water Soluable (Rx)
Agribon 12.5% Drinking Water Solution, Sulfadimethoxine 12.5% Solution

24. Specific Case Discussion Sulfas – AS700 Label Indications
Conditions of use—(1) Cattle. It is used in feed for beef cattle as follows:
(i) Amount. 350 milligrams per head per day each, chlortetracycline and sulfamethazine.
(ii) Indications for use. Aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever. (BRD)
(iii) Limitations. Feed for 28 days; withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
m htm (FDA Guidance Document)
Beef Cattle: Beef Cattle including dairy breed steers and bulls, designated by the letter "B".
CVM Partial Answers:
Once Ruminating - approved for use in beef breeds & steers and bulls of dairy breeds with a 7 day slaughter withdrawal. It should not be used in veal calves.
No clear answer at this time of use in pre-ruminating cattle, if you can use but need to contact FARAD for a withdrawal time or if it is improper extra-label use especially in dairy breeds.
No Combination Approvals

25. Specific Case Discussion Sulfas – Label Indications
Coccidia Sulfa Tx for Sheep & Goats
No VFD for Sheep & Goats
Can Use Rx Water Soluable Products Extra Label
Can use Amprolium (Corid) without VFD or Rx

26. Specific Case Discussion Macrolides – Products & Label Claims
Tylosin
Tylan, Tylovet100 
Tilmicosin
Pulmotil, Tilmovet
Label Indications
Liver Abscesses Only
Full feed (no pasture or hay) confinement situation only
Legal Combinations
MGA, Tylan, Rumensin combinations legal – combos a challenge
No CTC combinations legal with Monensin

27. Specific Case Discussion Ionophores, Coccidostats
Lasalocid, Monensin
Bovatec, Rumensin, Coban
Coccidiostats
Decoquinate, Diclazuril, Clopidol, Amprolium ,Others?
Decoxx, Corid, Amprol
Amprolium - No VFD needed for Crumbles for feed nor Rx needed for Water Soluble
Others
MGA, Heifermax,
Carbadox, Bacitracin, Beta agonists, Bambermycins

28. Specific Case Discussion Challenges – Extra Label Drug Usage
In my Opinion, the Biggest Challenge
People have been using it this way OTC (may have not known any better, some veterinarians didn’t either)
There are not many approved drug combinations (some labeled combos involve different mfg co. – ex. MGA/Rumensin)
Product labels are old – May not be sufficient for our cows today (ex. Anaplasmosis)
There are better ways to prevent & treat diseases in a herd other than antibiotic usage (ex. Pink eye, Bacterial enteritis)
There only a few exceptions that will be a true challenge
Foot Rot Cow/Calf – No VFD label, No efficacious vaccination
Liver Abscesses - continuous use
Anaplasmosis - continuous use, labels are old-for smaller cows, hard to determine when need to prescribe

29. Specific Case Discussion Challenges – Extra Label Drug Usage
Extra label Drug Use (ELDU) for feed grade products is illegal
Not new…..since AMDUCA 1994; actually has always been that way, it was just officially defined in 1994
What is extra label?
Different dose, route, frequency, duration, species, indication, and/or production class
Legal ELDU (Extra Label Drug Usage)
Allowed for prescription products
OTC products that are used extra label are prescription and requires a VCPR and veterinary oversight
Even with a VCPR, feed grade products have always been illegal to use in an extra label manner

30. Specific Case Discussion Challenges – Extra Label Drug Usage
What are Examples of ELDU that are not Allowed?
Feeding tetracycline to dry dairy cows
Lactating dairy cow = dairy breed animal>20 months
Feeding tetracycline for foot rot or pinkeye prevention
No indication
Feeding AS 700 to dairy heifers
Beef production class – beef and dairy bulls & steers
Feeding Tylosin at a higher dose or longer duration
Top dressing any product that is not approved to feed in combination with other products in the feed
Feeding Aureo or CTC with Monensin in feed - No approved combination
Feeding Mineral with CTC (Type B Feed - premix) free choice (Type C feed-complete feed)

31. Specific Case Discussion Others?
Type A feed (won’t write a VFD for Type A - feed mill will deal with these) vs. Type B feed (premix) vs. Type C feed (complete feed)

32. Cooperation with Local Feed Mills
Veterinary Feed Directive Distributor Notification List
Ask producers “What feed grade and water soluble products are you using?” “Do you have a valid VCPR established?”
Set up their VFD’s before Jan 1st
Talk to your local feed mill and work together
Do they plan to provide water soluble products & other script products? (must have a pharmacy license)
Paper or Electronic communication between you & the feed mill?
Let Local Feed Mill know you are willing to write VFD with valid VCPR so they can refer people to you
Develop a plan for how you will deal with specific cases
Ask them what are top products they sell so that you can prepare VFD for that product if there is a valid indication
Feed Mill responsibilities - Distribution Letter to FDA, Valid VFD, Storage requirements (2 yrs)

33. Tools for VFD Writing Efficiency & Accuracy
Global Vet Link
Rx Express (New Planet Technologies)
Smart Phone Apps - Free
TVMA Member Page – VFD Resource Page – free to members (Coming Soon)
American Association for Bovine Practitioners
FDA/CVM Website Links
Drug Company Resources
Other Resources?

34. Tools for VFD Writing Efficiency & Accuracy – Global Vet Link
Brief Description of Technology offered
VFD, Water soulable products, other script products
Electronic CVI
Digital Coggins
Cost
Subscription fee $24.95 / mo
Individual fees per
VFD - $5.00
Coggins - $4.50
Health Paper - $5.00
Water Soluable - ~$5.00 (pricing unknown)

35. Tools for VFD Writing Efficiency & Accuracy – Global Vet Link
Advantages
Training U-tube videos – will do personal training if requested
Health Papers, Electronic VFD/Rx , & Digital Coggins
Disadvantages
Have to have connectivity at all times
More expensive? Get more?
Ability for different users?
Feed Mill would have to subscribe to get automatically sent to them?

36. Tools for VFD Writing Efficiency & Accuracy – Rx Express
Brief Description of Technology offered
VFD, Water soluble products, other script products
Smart CVI
Cost
VFD $10/mo per user; $3 per VFD
Free Smart CVI for one year if sign up before Oct 1, 2016
Normally $25/mo for 1 vet; $50/mo for 2-5 vets; no fee for indiv. health certs.
Will more than likely develop discounts for using both programs after one year free (pricing not set yet)

37. Tools for VFD Writing Efficiency & Accuracy – Rx Express
Advantages
2 training sessions with you and your staff
Can use smart phone without internet service to fill out VFD’s - - will have to upload when connectivity available
Cheaper? Get less?
Ability for different users?
Easier to work with feed mill?
Disadvantages
No digital Coggins at this time – potential in the future

38. Tools for VFD Writing Efficiency & Accuracy – Paper vs Electronic
Electronic Technologies vs. Paper VFDs
Advantage
Safeguard from liability issues (making mistakes)
Decreases time for user entering and veterinarian signing
Storage
Disadvantage
Increased cost ? Maybe not?
Electronic of your own Making??
Utilize Forms provided by Drug Co.
Make into a PDF form that you can change on the computer
Unsure on cost
Greater Liability for storage

39. Tools for VFD Writing Efficiency & Accuracy – Smart Phone Apps
Zoetis V-Know – Labels for all Zoetis products
CVP – easy to search compendium for all products

40. Tools for VFD Writing Efficiency & Accuracy – TVMA VFD Resource Pg.
Archived VFD Webinars
Valuable Web Links
Summary Documents and Contacts for Computer Technology Tools for writing VFD’s (Global Vet Link & Rx Express)
Summary Documents from Drug companies
Many more Benefits for being a TVMA member

41. ZOETIS RESOURCES ResponsibleAntibioticUse.com
IMPORTANT RESOURCES
ResponsibleAntibioticUse.com
ResponsibleAntibioticUse.com/VFD

42. Other Burning Questions?

43. Local Food Animal Continuing Ed
Music City Veterinary Conference Feb 24, 2017
Pat Gordon, DVM, AAVP Dairy Practice, Production Animal Medicine Iowa State University
VFD Updates and Practical Tips on Writing VFD’s
The VCPR and what it means
Chris Chase, DVM, PhD, Veterinary & Biomedical Sciences South Dakota State University
Practical Immunology
Vaccines – Which ones? How many? When?
Joe Hillhouse, DVM , Rural Mixed Animal Practitioner, Panhandle Texas
Changes in Practice Needed for Rural Practice Sustainability
Mixing It Up in Mixed Animal Practice--How Do I Benchmark My Practice
Mixed Animal Geeking Out--Some Technology Practice Tips