Veterinary Feed Directive Dr. Whitney Whitworth Lyssy & Eckel Feeds

Not a new concept Animal Drug Availability Act (ADAA) enacted in 1996 Prior to that, only two options for dispensing drugs, over the counter & prescription Drug companies were asked to revise their labeling to remove claims of growth promotion and feed efficiency in December 2013 Created the veterinary feed directive (VFD) drugs Final rule into effect October 2015 Full implementation January 1, 2017

Why? Congress recognized that certain drugs should only be administered under veterinarian’s order and professional supervision There needed to be controls over certain antimicrobials Control necessary to reduce overuse of drugs and to prevent bacterial resistance Also difficulty in diagnosis or toxicity issues

What is a VFD? Written statement issued by a licensed veterinarian that orders the use of a VFD drug or combination VFD drug in or on an animal feed Feed can only be fed to animals on the written VFD for the specified time Veterinarians must have knowledge of the animal, its health, the facilities it is housed in and be available for any follow-up evaluation and care

Information required on a VFD Veterinarian’s name, address & phone number Client’s name, address and phone number Premises which the animals in the VFD are located Date of VFD issuance Expiration date of the VFD Name of the VFD drug Species and production class of animals to be fed Approximate number of animals to be fed the VFD by the expiration date

Information required on a VFD, contd. Indication for which VFD issued Level of VFD drug in feed and duration of use Withdrawal time, special instructions, and cautionary statements Number of reorders authorized, if permitted by the drug approval, conditional approval or index listing The statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling, is not permitted” Affirmation of intent for combination VFD drugs Veterinarian’s signature

VFD may include the following More specific location of the animals Approximate age range of the animals Approximate weight range of the animals Other information appropriate in identifying the animals

Special Considerations Street address is usually sufficient for location, but GPS may be necessary More detailed descriptions may be necessary Animals managed similarly in different locations may fall under the same VFD No feed in a VFD can be fed after the expiration date Expiration date will not exceed 6 mo after date of issuance Based on calendar date, not number of days Duration of use may also be specified If a drug has multiple approved concentrations, veterinarian may authorize a particular level or the entire range of approved dosages All parties (veterinarian, client, distributor) must keep a copy of the VFD for two years

Special considerations, contd No extra label use is allowed Veterinarian must send VFD to distributor in hard copy or electronically If the VFD expires before you have fed all of a VFD feed, you must get a new VFD.

VFD drugs -- feed Antimicrobial Class Specific Drugs Approved for use in Feed Aminoglycosides Apramycin, Hygromycin B, Neomycin, Streptomycin Diaminopyrimidines Ormetoprim Lincosamides Lincomycin Macrolides Erythromycin, Oleandomycin, Tylosin Penicillins Penicillin Streptogramins Virginiamycin Sulfas Sulfadimethoxine, Sulfamerazine, Sulfamethazine, Sulfaquinoxaline Tetracycline Chlortetracycline, Oxytetracycline

Rx drugs – water Antimicrobial Class Specific Drugs Approved for use in Water Aminoglycosides Apramycin, Gentamicin, Neomycin, Spectinomycin, Streptomycin Lincosamides Lincomycin Macrolides Carbomycin, Erythromycin, Tylosin Penicillins Penicillin Streptogramins Virginiamycin Sulfas Sulfachloropyrazine, Sulfachlorpyridazine, Sulfadimethoxine, Sulfamerazine, Sulfamethazine, Sulfaquinoxaline Tetracycline Chlortetracycline, Oxytetracycline, Tetracycline

Drugs not affected Drugs not medically important Ionophores (monensin, lasalocid, etc.) Bacitracin (BMD, bacitracin zinc) Bambermycins Carbadox Drugs that are not antimicrobials, for example: Anthelmentics: Fenbendazole, Ivermectin Beta agonists: Ractopamine, Zilpaterol Coccidiostats: Clopidol, Decoquinate, Diclazuril

Difference between a VFD and a prescription When the drug will be used in a feed, it is a VFD drug When the drug is not used in a feed, it may require a prescription Written so that there would be oversight of important drugs without infringing on pharmacy laws

Feed classes -- Mills Type A Type B Type C Must be used to manufacture type A, diluted to type B or C feeds Type B Must be only used to manufacture B or C feeds Will contain at least 25% ‘other’ ingredients Type C Intended to be fed to an animal, either complete or top dressed

Feed labels, types B & C Name of feed, species and production class Drug and combination names should make it distinguishable from other Indications for use Active drug ingredients Dosages or concentrations should be listed Guaranteed analysis Ingredients ‘Ingredients as defined by AAFCO’ Mixing directions – Type B Feeding instructions – Type c

Feed labels, types B&C…contd Caution ‘Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian’ Warning Ex. ‘Withdraw 5 days before slaughter’ Manufacturer information Weight Statement Other label information Lot, batch, control number Expiration date Other information deemed necessary

Drug X/Drug Y Growing Turkey Ration Type B MEDICATED FEED For the prevention of coccidiosis caused by Eimeria meleagrimitis, E gallopavonis, and E. adenoeides and for increased rate of weight gain and improved feed efficiency in growing turkeys. ACTIVE DRUG INGREDIENTS Drug X ...........................................................................…….…………….……….....80,000 g/ton Drug Y…………………………………………….……………………….........……………6,000 g/ton GUARANTEED ANALYSIS Crude Protein (min)……………………………………………….........................................…..……….…..______% Lysine (min)………………………………………………………...........................................….….….……..______% Methionine (min)…………………………………………………...........................................….….….……..______% Crude Fat (min)……………………………………………………...........................................………..……..______% Crude Fiber (max)………………………………………………………............................................………..______% Calcium (min)…………...………………………………………………………………………..……..….……..______% Calcium (max)………..…………………………………………………………………………..……..….……..______% Phosphorus (min)…..………………………………………………………………………….……….………..______% Salt (min)1……………..…………………………………………............................................………………..______% Salt (max)1……………..……………………………………...........................................….………...………..______% Sodium (min)2…..……..…………………………………….........................................………….. ......……..______% Sodium (max)2….……..…………………………………..........................................………………....……..______% 1If added. 2Shall be guaranteed only when total Sodium exceeds that furnished by the maximum salt guarantee. INGREDIENTS: Ingredients as defined by AAFCO. MIXING DIRECTIONS: Mix 10 pounds of this Type B medicated feed with 1990 lb non-medicated feed ingredients to manufacture one ton of complete turkey feed containing 400 grams of Drug X and 30 grams of Drug Y. CAUTION: Do not feed to breeding turkeys. WARNING: Do not feed five days before slaughter. MANUFACTURED BY: BLUE BIRD FEED MILL Robin, IN 00000 Net Weight____lbs (______kg) Bag or Bulk

Take home Still ironing out the details Part of doing business Will take getting used to by everyone