VFD QUICK REFERENCE GUIDE COUNTDOWNJOVFD 201

Transcription

1 VFD QUICK REFERENCE GUIDE COUNTDOWNJOVFD 201 FOR VETER NA Changes to the Veterinary Feed Directive (VFD) regulation take effect January 1, Take action to be prepared for and be in compliance with these changes. ThETIS PRODUCTS THAT Will. REQUIRE A VFD A v:rrlten JFD I: our a veterina r an is required be; ore hese products VFD ROLES A D RESPONSIBILITIES may he delivered arid incorporated into reed. Whether obtaining a VFD via an electronic system or on paper, it is important to understand the different roles and responsibilities for veterinarians, producers and the feed mills. VETERINARIANS ARE RESPONSIBLE FOR. Helping clients understand need for a veterinarian-client-patient relationship (VCPR) Being licensed in the state the animals reside Diagnosing the need and determining the VFD medication necessary Ensuring label indications are followed - Issuing a written (nonverbal) VFD Providing a copy of the VFD order to the client (and feed distributor mill or retailer if filing electronically) Maintaining original VFD records for two years for each VFD PRODUCERS ARE RESPONSIBLE FOR Providing the best estimate for the number of animals and expectation of feed consumption Providing the VFD order to the feed distributor mill or retailer (unless the veterinarians provided it to them) - Maintaining a copy of each VFD order for two years Leaving adequate time for getting new VFDs from the veterinarian and for the feed mills to fill the order FEED DISTRIBUTORS - MILL OR RETAILERS - ARE RESPONSIBLE FOR: Ensuring the VFD is filled out correctly, compliant with feed labels and the amount of feed requested is reasonable Filling the order Maintaining a copy of each VFD order for two years UNDERSTAND THE T PRODUCT AuREOMYCIN chlormax LINCOMIX AUREOMIX S 10/10 AUREOMiX S 40/40 AUREOS700 RofenAid - - I orionhare. coccidioslal and haciua:in ptodu:;s II rrol t me a VI U a nless user 111 combination.11th rich ally,rri)qha;ii antjh,oli(s. OPTIONS FOR COMPLETING A VFD ORDER - GlobalvetLlNk: ELECTRONIC VFD globalvetlink.com/products/feedlink OR EVFD - RxExpress: dvmrxexpress.com - VFD Management Tool from Zoetis for PAPER FORMS cattle products - PDFs of paper forms available on ZoetisuS.com/VFD Transition labeling will begin to appear during 2016 on all feed containing medically important antibiotics that will require a VFD beginning Jan. 1,2017. Products requiring a VFD but distributed prior to receiving a transition label can still be used after Jan Final labeling will be implemented after Jan , to state that this product will require a VFD and that use in an extra-label manner is not permitted. Aureom nw i~ On~b, 1~ S. Transition iabei exampie. NSITION LABELS Beginning January : This product wiill require a veterinary feed directive issued by a licensed veterinarian and will be subject to the following restriction Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. This product will no longer be approved for the indication of: increased rate of weight gain and improved feed efficiency which means the use of this product for these purposes will no longer be legal after that date. 21 CFR (a)(6) Have questions? We are here to help. Con act Zoetis Veterinary Medical Informa ion Product Support (VMIPS) at ZOETIS1 ( ) or submit a question onune at ZoetisUSco n/vm PS. oetis

2 VETERINARIAN FAQ WHEN 5 A R[OU[RED? WHAT SHOULD I DO TO ENSURE! HAVE A VAL[D VCPR WITH MY CLIENTS? A VFD is required when feeding an antibiotic considered medically important to human health to animals. Some medicated feeds contain antibiotics not medically important to human health such as bacitracin, anticoccidials or ionophores; these feeds do not require a VFD. Knowing when a VFD is required can get a little confusing when dealing with Type A medicated articles or Type B or C medicated feeds A To ensure you have a valid VCPR. it is best to get it in writing in a document or calendar schedule demonstrating the producer is on your list of veterinary visits and business. This will help ensure understanding of responsibilities and expectations between you and your client, as well as provide necessary documentation should an investigation happen. TYPE A MEDICATED ARTICLE A VFD is not required to purchase a Type A medicated article as it is not feed. Once diluted and mixed with other feed, a VFD is required in order to feed to animals. WHAT ELSE DO I NEED TO DO WITH MY CLIENTS TO PREPARE FOR JAN. 1,2011? TYPE B MEDICATED FEED TYPE C MEDICATED FEED (THIS COULD BE TOP DRESS. COMPLETE FEED OR FREE CHOICE) A VFD is required to purchase and to mix into final Type C medicated Feed. A VFD is required as this is the final feed that the animals will consume. A After establishing a valid VCPR, take the time to review animal health protocols with the producer/animal owner and become familiar with the feed medications your clients are currently using. Note which protocols and Type B or C medicated feeds contain an antibiotic medically important to human health which will require a VFD. Meet the producer/animal owner and nutritionist in order to talk about and decide how you will interact with both parties and include them in health and wellness discussions. Discuss the reasoning fpr the drug and the steps that need to be taken to get a VFD for that medication. Review the current rations and timing to ensure they match with the V~D label claims and address any discrepancies. WHAT IS HE FIRST THING I NEED TO DO TO ENSURE I AM PREPARED AND COMPLIAN? It is important to document everything. Have standard operating procedures (SOPs) in writing For the steps you take to comply with Guidance for Industry 213/VFD regulations, as well as doing business with a producer on diagnosing a condition in order to authorize a VFD. This will be clear to your clients as well as inspectors if you are ever under investigation regarding a VFD. Mi iia~trnaks no he piop,iio ci lots Stoics tic oi a ieiaiod coi1wa~y Si a I (east voitss oiheswot stied. lois leoiis Senile, ttt. All eghis e~eised. NA-0C911 COUNTDOWN TO VFD zgetis

3 Veterinary Feed Directive (VFD) Regulation pdate The U.S. Food and Drug Administration (FDA) published three Unaffected Affected reports in December 2013 outlining upcoming changes for the Non-Medically Important Medically Important use of antibiotic products in production animals. The goals of Products used exclusively Products deemed important for human these changes are to: in animals: medicine and used by both animals and Promote judicious use of antibiotics - lonophores humans, such as: Protect public health - Penicifllns Help limit the development of antimicrobial : - Polypeptides - Macrolides - Garbadox - Sulfas Q~nolone: - Bambermycin - Glycopeptides resistance Fluoroquinolones - Pleuromutilin - Others Changes in the VFD process will help support a more - Tetracyclines streamlined approach to the judicious use of antibiotics. The final rule published June 2015 provides clarification on the requirements for veterinarians, feed distributors and producers. Veterinarian requirements Must be licensed to practice veterinary medicine and operate in compliance with appropriate State-defined veterinarian-client-patient relationship (VCPR) requirements - In states where the practice requirements do not require that a VFD be issued within the context of a - Still allowed - Enhance growth or improve feed efficiency - No longer allowed Still allowed under veterinary supervision to: - Treat animals diagnosed with an illness - control the spread of illness in a herd VCPR, FDA is requiring that the VFD be issued within the context of a Federally defined valid VCPR, which requires that the veterinarian: Engage with the client to assume responsibility for making medical judgments about animal health and the need for medical treatment Have sufficient knowledge of the animal by virtue of examination and/or visits to the facility where animal is managed to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s) Provide for any necessary follow-up evaluation or care Prepare a written VFD (paper or electronic) including all required information Issue VFD in compliance with the conditions for use approved, conditionally approved or indexed Write the name of the VFD drug on the VFD - May choose to write the name of a pioneer or generic drug name - May choose to specify that a substitution of a drug is not allowed; if not specified, the feed distributor may choose to substitute if the generic VFD drug is part of an approved combination VFD drug Include information about the location (e.g., address) of the animals that would allow someone to locate the animals and may include specific additional information (e.g., pen) - If a VFD is intended to authorize the use of a VFD feed in a group of animals that are located at more than one physical location, it is acceptable to include multiple specified locations for that group on the VFD, provided 1) they can do so in compliance with professional licensing, and 2) the feed is supplied by a single feed distributor Provide a copy of the VFD to the producer (client) and feed distributor, and maintain all original VFD records for 2 years Producer requirements Feed animal feed containing a VFD drug only to animals based on a VFD issued by a licensed veterinarian Do not feed a VFD feed after the expiration date on the VFD Maintain all VFD records for 2 years - Enhance growth or improve feed efficiency - Prevent illness in healthy animals when exposure is likely

4 Feed distributor requirements May only provide a VFD feed if the VFD contains all required information, complies with terms of the VFD and conforms to product approval Provide one-time notifications - Notice To FDA of DIstrIbutIon of VFD Feeds that they intend to handle/distribute VFD drug-containing medicated feeds - Acknowledgement of Distribution Limitations for VFD Feeds that the purchasers will sell the VFD feeds only to producers with valid VFD orders or to other distributors for whom they have acknowledgement notices Maintain all VFD records for 2 years Other clarifications Defining distributors - On-farm mixers that only manufacture medicated feeds for use in their own animals are not distributors - On-farm mixers must only be manufacturing VFD feed for their use in their own animals on their own farm, meaning that the ownership of the feed mill, the animals and the animal production facility must be the same and the on-farm mixer must be the person using the VFD feed - If an on-farm mixer distributes to another producer, that mixer will be considered a distributor - If a producer wishes to receive a VFD feed without a VFD in hand, they must follow the notifications required for a distributor and they may not feed the VFD feed without a valid VFD in hand Expiration vs. duration - The expiration defines the period of time for which the authorization to provide an animal feed containing a VFD drug is lawful Expiration date specifies the last day the VFD feed can be fed to a group of animals The vet should use the valid length of time that is specified on the label; where such date is not specified, the vet can write a date up to 6 months from the date the VFD is initiated - The duration determines the length of time the VFD feed is allowed to be fed to the animals, as specified on the product label VFD drug classification eliminates current automatic classification of VFD drugs to Category II status, which would have required mills making VFD feeds to have a federal medicated feed mill license FDA enforcement strategy - Provide education and training for stakeholders subject to this final rule such as veterinarians, clients (animal produc ers), feed mill distributors and other distributors - Engage in risk-based general surveillance, as well as for-cause inspection assignments Elanco Elanoo and Urn dagooal by are all kademasks owned as licensed by Eli Lifly and Company, Its subsidlasles or affiliates. O2OlbEbnco*jdmalHeamt USBBUNONOI 500

5 Swine Antibiotic Product Classification and Veterinary Feed Directive (VFD) Requirements1 FULL V LUE PIGS In-Feed Antibiotics that are Medically Important wwatrawi Withdrawal Product Ingredient Company ~.~usr Period Class Shared VFDAtter2OSI2l3 CEXPOIt5)~ Class Implementation Aivlosin 1 7% t~alosin Pharmgate/ECO 0 days 0 dayst macrolide yes YES* tetracycline Auceombc S chiortencycline a Zoetis 15 days 15 days ~ yes YES Aureomycin chlortekacycline Zoetis odays I4days tetracycline yes YES CHLORATEP4 rteflcydfine AOMAH 8h ifl~t 14 days tetacydine yes YES GhIorMwa~) 50 chlortetracycline Zoetis 0 days 14 days tefracydine Ye~ YES Uncomix lincomycin Thetis 0 days 0 days lincosanside yes YES Neo-Oxy 100/1 0B or rleomyclfl asia 0 days be dose 14 days a09~05~ oxytefracycline Ptiamigate/Jinhe 5 days h~h dose yes YES and tefracydlte noomycin I day low dose eminoglycoaicie Neo-Terramycin 100/100 ofra~iira Phibro 5 days high dose 14 days yes YES ~ teracydina Nutior fiofenicol Merck 13 days 13 days anphenlcot yes YES* Penicillin 100 penicillin G procane Zoetis 0 days 3 days peniali, yes YES m Pesinchior SP 500 chiortetracydlne sulfamethazlne 2 Pharmgate/Jinhe 15 days 15 days penidhlin. ten~ane yes YES Pennohlor G penicillin ~ 00 Hi-Ao ~, and chiortotracycline Phamigateljinhe2 0 days 14 days tetracydine yes YES ~ Ni-FIo, oxytetracydtne PharmgatelJinhe 0 days 14 days tencydine Ye~ YES Pulinotil 90 PIONEER filmicosin phosphate Elanco 7 days 7 days ninoide yes YES5 Stelaas) *gthian,ycln Phibro 0 days 0 days afrs~togramin yes YES Terramycin 50, 100, 200 oxytetracydine Phibro 0 days be dose 14 days tetracydine yes YES Tilmovet 90 GENERIC tilmicosin phosphate Huvepharma 7 days 7 days macrotde S O~ YES5 Tylan Sulfa-& sulfametliazine tylosin and Elanco 15 days 15 days macrosde ~O5 YES Tylary!). PIONEER tylosin phosphate Elanco 0 days 0 days macrot~e yes YES TyIOVet, GENERIC tylosin phosphate Huvepharma 0 days 0 days maorotde Y~5 YES Product requires a VFD today. tdifferent withdrawal limes may be required for certain markets. hflp/kaws.pork.orglpowk-export-product-wilhdravmnw (All tetracycline products follow National Pork Producers Cotncil voluntary 14-days wthdrewal period) Resources: Feed Additive Compendium 2012 Guidance for Industry 209 and 213 and Code of Federal Regulations 558 Summary Report on Mlbntcrobial Sold or Distributed for Use in Food-Producing AnThals (April2015) In-Feed Antibiotics that are NOT Medically Important Product lngr.dl.nt company Withdrawal Period (US) WIthdrawal P.rlod Class Shared VFD (Exports) Class RequIred AIbaoS bacltradn zinc Zoetis 0 days 0 days polypeptide yes No bacitracin BMD mem~ien. Zoeiis 0 days 0 days polypeptide yes No dsdcilate Denagard daniulin hvdro9en Elanco 2 days 7 days pleuromutilin yes No 35 giton fi.imarate Denagard tia yajlin hydrogen 200gIton ftamnte Elanco 7 days 14 days pleuromutilin yes No Flavomycin bambermiydn Huvepharma 0 days 0 days glycolipid no No Kavauitm sullainydn Elanco 0 days 0 days orthosomydn no Yes Mecadox 5 carbadox PNbro 42 days 42 days qulnoxatine no No Pennitracin MD 50Gm met~51ene badtrscln ctsaecytete Pharmgste/Jnhe 0 days 0 days polypeptide yes No Skycis naraaln Etanco 0 days 0 days ionophore no No Product requies a VFD today. htlp:thw,w.poflc.org~pork-export-product-withdrawal-mrt! I. Non-hndrig recommendations based on FDA, GsMdanca for Industry # Pl,amgste U.G is the m~o.ity-owtsed Us subsidiary of Jirdie BiotacNiology Ca U~ 3. Pharmgste Animal Health LLC is the johit venture between Pharngale (IC and EGO Animal Health This list is not all indualve. The label contena complete use information including cautons and warnings Mways read. understand and follow the label arid use directions as well as consult your veterinarian Elanco Full Value p195m Denagard Kavault~, Putmotil Skyds. Tylan aid the diagonal bar are trademarks owned or licensed by Eli Ully end Company its subsidiaries or affiliates El Lilly and Company its subsidiaries or allteatea Elanco USSBUMULO1264(?)

6 Water Soluble Antibiotics that are Medically Important I Product ln~dl.nl con~any ~r~j tmthdrawal Period Class Shred Class kksm VI~tr Sdutie Ga *eb~n b&ate Pha mgateieco Odays Sdays macrofide yes YEV GeriGa d gelanido saaie AgñLabs 10dm 17dm aminogyco&de yes YES Linconizt &b~ue Powder Wicomydn Zoefis Odays Odays lincosamides yes YES Un~n~dn SOMe in~qdn Ha Zoelis Odays 0dm lircosanides yes YES NedAedt SOMde Powder neonydn sulme Binwda, Inc Sdays 3days an~no~yco&de yes YES Neo-Sd rieen~dn si~te Zoelis 3days Sdays anirioglycodde yes YES FflIC 2.3% PIONEER fiorfenicol Merck l6days 16dm amphenicol yes YES ox$e some oqtetacydne Ha Zoebs Odays l4days tebacycine yes YES PemidW 64~ diortefracycine HC~ Pliaingatelinhe Odays I4days tefracøne yes YES PeT.OX 343N o~tracydine Phzn~aI&he Sdays l4days tetiacydine yes YES Ptd ACt ftricodn phos$iale Elanco 7days 7dm macrowe yes YES TerTaa!êt34SSduNePuIoder oxytefracydine Zoetis 0dm 14dm teftacycine yes YES Tenae~àt some Powder oxytefracydine Zoelis 0dm 14dm tetracydine yes YES TebMd 324 HCASoêk Powder tetacyctne Ha Otroda, tic 4dm 14dm tefracydne yes YES Tet.se10~324 tfltydne Ha Zoe& 4dm 4dm macdde yes YES rebuay ICA SaWe Powder oqtetacycfne Ha ~imda, Inc. 0dm l4days tetracyctine yes YES T~~ISOMeM0?fER tyieäniat~e Elanco 4hns 2dm macwide yes YESt T~beI~SohteoEwmc tøodntarfrale Huvephamia 4boiis 2dm macrome yes YEV Befor. using Pulmoill AC. It Is Important to read the entire product Insert, Including the boxed Requires a prescription today. httpi/ Water Soluble Antibiotics that are NOT Medically Important Wll,*ndhded I WlthdrawsIPerled Product lngredi.s.t Company (usr I (Expertal ENDS Selutle 50% M str Soluble) I bacitadn dteslcttsie methylene Zoatis 0 days I t ~ De~LC-1D.5ITlØt~y I llamuhnhydrogen Elenco 7d.ys I l4days wel9livdsy dose rate lumar~~ DensgaSeLC-3.Smgilbbody I tiamutnhy&o9en nl&ivdar dose rote fumsrato Elenco Sdeys ltdeys Injectable Antibiotics that are Medically Important All Injectable antibiotics are outside the scope of Guidance 209 and 213 human warning. Product Ingredient Con,p.ny Wlthdrow.l Parted ~ Withdrawal Period ~sxpera~ class Sharsd Class Script RequIred BeynillS 100 enrofloxscln bayer.~fllmai Heolth 5 days 14 days fluoroquinolone YES YES Dra,odsn Inleclabla tulsthrornycln Zoetls 5 days 28 days macrolide YES YES Solution Exoedee for Swine ~flofur 075t551F10 Zoetls 14 days 48 days cephalosporin YES YES Sterile Suspension free add CO~t1MC RiO ~ zoetis 4 days 5 days cephalosporin YES YES Sterile Suspension hydrochloride Exoenele RTU Sterile camonir Zoetls 4 days 5 days cephalosporin YES YES suspension hydrochloride LincoMed 100 Injection Lincomydn HCI Bimada, Inc. 48 hr. 4 days llncosamides YES NO LlnooMed 300 Injection Lincomydn HCl Bimeda, Inc. 48 hr. 4 days lincosamides YES NO Llnoomlxe Injectable Lincomydn Zoetis 2 days 4 days lincosamides YES NO tiqusmycine LA200~ oxytetrscycline Zoetis 28 days 28 days tetracycline YES NO Injectable NaxcELeSterIle ceftiofur sodium Zoetis 4 days 4 days cephalosporin YES YES Powder Pro PenOlnlactable Suspension par~diiin C Bimeda, Inc. 6 days 15 days penicillin YES NO Tebo ty LAInlecdon oxytetracycline Blmeda. Inc. 28 days 28 days tetracycline YES NO Tylenlnjeetlon tylosin Elanco 14 days 14 days macrolide YES NO httpjknw,.pork.orgfpork-export-product-withdrawal-md/ Elonco USSBUMULO1264(2)