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

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

NEW VFD FORM (BOTTOM HALF)

NEW VFD FORM (TOP HALF)

NEW VFD FORM (BOTTOM HALF)

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?

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?

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?

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.

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

Veterinary Client Patient Relationship (VCPR) – Veterinarian Obligation

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?

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

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

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

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

Specific Case Discussion Tetracyclines – Product Approvals

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

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

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

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.

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?) http://www.fda.gov/animalveterinary/developmentapprovalprocess/mi 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

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

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. http://www.fda.gov/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/uc m053406.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

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

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

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

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

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

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)

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)

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)

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?

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)

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 email automatically sent to them?

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)

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

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

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

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

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

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