Veterinary Feed Directives
Feed Additives, Veterinary Feed Directives
On October 1st 2015, the Veterinary Feed Directive program (VFD) went into effect to help reduce the amount of antibiotics used in food animal husbandry. Contrary to what some of the nationwide and fast food and grocery stores have been advertising since 2015 this program was actually started in 1996 with the tilmicosin antibiotic drug. In 2012 the FDA took the final steps to implement the VFD program to take effect 5 years later and thus allow the industry to change and prepare for the labeling, paperwork and other requirements. The FDA first published the VFD rules in 2010 and later the final version in early 2015, and only then did many fast-food companies say they will be having the over-the-counter antibiotics (OTC) and other medicines removed from their sources of meat, milk or eggs; they did not mention these federal laws were set up 5 years earlier to prohibit the use of these OTC antibiotics in the feeds. There will be no more OTC/non-prescription feed antibiotics available to use in food animal species. The VFD program was developed to control the unnecessary antibiotics and drugs going in to the animal’s feed and water. Insecticides (and dewormers) are not FDA regulated and are not VFD products, but instead they are under EPA control as FYI; yet these products do have drug withdrawal times as do all products for food animal use, including aspirin.
This will include someone with only one animal that is a pet of a food animal species (i.e. a pot belly pig, rabbit, pet chickens and other similar species are regulated by these VFD laws).
With this program essentially the antibiotics earlier available for medicated feeds will now need a paperwork trail and an approval by a food animal veterinarian. Since 2015 there has been a drop of 38% in the use of antibiotics used in animals in only 3 years per the FDA. This is how it has been done in other countries for many years. The same feed stores and mills will be able to sell the medicated products, but prior approval will be needed and the paperwork will first need to be completed. Phone or oral approval is not allowed. The VFD form can be sent by fax, email/electronically, by mail or on paper in person to those selling the products. Some distributors/manufacturers will have convenient forms available for their own file, the producer’s copy and also for the veterinarian’s copy. All 3 parties must keep their copy for 2 years. The FDA estimated it will take 0.25 hours for a veterinarian to complete the paperwork, which is a longer than a prescription. The maximum VFD will expire in 6 months. In summary the VFD product itself will not expire in the 6 months maximum time period, and instead it is only the use of it for the specific animals on the VFD form. Producers should keep the unused VFD product if there is any excess so that this product can then be used when a new VFD is issued if/when needed, if the product is not outdated per the FDA manufacturing label. Since the 1990’s the “standing order” or “open prescription” for medicines has been illegal, and this includes the VFD’s. There are some VFD’s which will not allow a refill order, and a few antibiotics will allow a preapproved refill order on the VFD if more product is needed; usually a second VFD will be required if more product is needed. There are no extra-label use (ELU) of any VFD. A veterinarian can write a VFD for an approved product only, but cannot write a VFD for an OTC product that is not VFD listed. It may seem strange but the chlortetracycline in the feed (VFD) cannot be used extra-label, but the veterinarian still has the ability to use oxytetracycline in the water treatment for extra-label use under the other prescription laws. For the website for the VFD regulations you can go to FDA/CVM website at fda.gov/AnimalVeterinary. The www.ResponsibleAntibioticUse.com/ufd is yet another site. In late 2016 there will not be any antibiotics sold for growth promotants and/or feed efficiency; they still will be available to treat sick animals, flocks and herds under a VFD label at a treatment dose. Eventually the water antibiotics will also be included, and then years later other similar antibiotics for almost all animals, fish, etc similar to the rest of the world. This will also help our food export products as there is now a trace back system for antibiotics in food animals. Some older antibiotic feed products will not be sold anymore as their current lower ineffective treatment dosage needs to be corrected, similar to the removal of penicillin-streptomycin decades ago as a product with an ineffective dosage label. The same antibiotic can be used at the correct dosage to treat sick animals if the manufacturer chooses to relabel the product. The injectable and oral antibiotics are not involved in the VFD rules that take effect at this time.
Whether it be a milk replacer or an animal feed, the antibiotics that are currently involved for a VFD approval are chlortetracycline, neomycin, oxytetracycline, tilmicosin, tylanosin and virginiamycin. One cannot mix a VFD product into an animal’s feed and give/sell to another party unless you have a license to do so. Mineral supplements will also require a VFD if they contain a regulated antibiotic or drug; most of these are custom mix mineral products. The brown mineral blocks that we commonly recommend are not VFD products.
The feed additives of bacitracin, coccidiostats, lasalocid, monensin (Rumensin), salinomycin, other ionophores and MGA will not need a VFD as these are not important antibiotics and/or they are not a concern for human health; their use will remain the same as before. If these products are mixed in with a VFD product then they will be regulated and their directions involved in the VFD certificate.
As a FYI Summary:
The over the counter (OTC) feed products will now be called VFD’s. Only antibiotics that are labeled for use in VFD approved feeds can be used. A prescription for an OTC antibiotic for use in a food animal feed that is not a VFD product is not allowed.
Category I products have no drug or food withdrawal times; their use will remain the same. Category II products require a Type A licensed feed mill to mix up. Some of these classifications are just FYI since the FDA likes to use these terms in their VFD rulings.
Type C medications are the least regulated as they have no major concerns or withdrawals.
Type B medications are products used by distributors to make type B and C products, as FYI.
Type A medications are drugs with a withdrawal time. These are the new feed and water drugs being approved in their concentrated form. Type A medications are used to make Type B and C medications.
The approving veterinarian needs to have visited the farm and have knowledge of the operation, besides being licensed in that state, etc as required for a prescription drug. A distant veterinarian may not be able to do follow-up examinations, and since this may be an issue it will then be a violation of the VFD laws.
To request a VFD the producer must know the exact location of the animals; address and pen location(s) if applicable. The number of animals to be medicated, plus their weights. The species and ages of animals to be fed the medicated VFD product.
The above information is needed before a VFD request can be made. The dosage and length of treatment is determined by the approved labeling for that VFD product. A new VFD is required for any other animals, to add on a different location, obtain a refill and/or add a different drug if the information is not on the original VFD form. There will not be allowed any VFD forms allow “for products to be on a request hold if needed later”; once submitted the feed needs to be made up. As with any prescription type of request the distributor cannot alter the VFD form.
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VFD’s and Bees
When the 2015 VFD rules took effect 1/1/2017 bee keepers are now required to have a VFD to obtain oxytetracycline, tylosin or lincomycin powder(s). Technically the DVM needs to examine the bees per federal rules.
Below are the suggestions and options to keep up a valid client-patient interaction. There is also a VFD log/record for bees, besides other forms for other species of animals.
VFD Rx Policy for bees and also mammalian species, poultry, livestock and/or commercial food fish operation(s).
There has never been a fee charged by our clinic for a prescription, since an Rx or a VFD has required a patient-client interaction within the last year or so. Unless there are more than 2 VFD’s per a single test there will not be a paperwork fee for one year; other services and purchases from this and other patients under the same file name will increase the amount of VFD’s possible. This policy will always be free for prescription items, since they take 90% less paperwork time per authorization.
If we have seen the mammalian patient within the last year, or a fecal exam, urinalysis exam or similar test needs to be performed, plus the information in the VFD producer’s log record. For herds and flock medicines not all animals are required to be examined yearly. A request for a specific drug of concern and/or for an individual animal may require an exam for that patient; usually this is a prescription drug and not a VFD.
Instead of a laboratory exam test a farm call and visual exam can be performed. We also provide greatly reduced service fees for split farm calls, where we do the exam the next time we are in the area at our convenience. A specific appointed time usually requires a regular call fee, although if scheduled at the same time for another premise in the area there can then be a split fee. Most of the premise exams are by the hour.
If we have seen other patients of the client in the last year, the requirements above may not be required if we have an earlier fecal exam, etc on record. A VFD producer’s log record review is still needed.
VFD Rx Policy for BEES:
For a request for a veterinary feed directive (VFD) for bees we will require at a minimum a yearly test for mites using 10-50 or so bees that the client brings in. In the fall when you see the males are being pushed out of the hive this is an opportune time to bring in the yearly sample of 50 or so live bees; after collecting you can place them in the refrigerator until they are cold, then add some 70+% alcohol (denatured alcohol or vodka) to kill/preserve them. You can also add a tablespoon of ethyl or methyl alcohol to the collection jar and keep at room temperature once they are inactivated. 10x bees is a minimum and up to 50 bees will enable us to perform more accurate testing. An easier and recommended method for collecting bees is to place a tablespoon or so of rubbing alcohol into a disposable food type container and gently use the lid to catch/wipe the bees into the container; in a minute the bee will no longer be able to sting or escape. After collecting take this container and pour the bees and alcohol into a zip lock bag; allow the bag to be open so the alcohol can dissipate. After there is no liquid you can close the bag up to bring into the clinic or send to us. If sending the vial into the clinic you will need to use special precautions, double vial type of packaging, etc per US Postal regulations and/or UPS, FedEx, etc; contact them first for the current protocol. Send the alcohol preserved dead bees to arrive at the clinic within 2 days. Collect the bees to be tested BEFORE you treat for tracheal mites, and collection may need to then be before fall, yet after honey has been collected. The test for mites will also have a test for microsporidia. We will alternate the testing of the bees (fall) with the testing of the honeycomb (summer).
For new clients that have no animals on file, the results needs to be performed first before calling, faxing or writing an Rx for VFD’s. The client can purchase the product at the clinic when they drop off the dead bees, and note which hive/location they came from. The final authorization to use the product will follow with phone call, after the test is performed. This same requirement will also apply if it has been 1.5 years since the last service in the file (for bees, other animals and/or purchases). We will perform a stop by call to look at the aviary. VFDs require that we record the physical address or a GPS coordinates for the locations for all of the hive(s) that you have.
If you have larvae/pupa that are dying, please bring in some fresh dead pupae so we can stain and possibly culture the inside of the pupae for Paenibacillus (American foulbrood) and other diseases. A prime time to look at the larvae is when you are examining the frames each summer, or at the latest when you are harvesting honey which is on average from late July to early September in our area. These dead/dying larvae can be brought in as is in the comb. Do not freeze any specimen samples.
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Veterinary Feed Directives, summary
Although the veterinary feed directives went into effect in 2015, the enforcement became firm on 1/1/2017. The USDA/FDA placed this time lapse in order for producers-veterinarians-feed mills/distributors to be ready for these changes. We have provided a background handout and Facebook/website postings since early 2015 to help alert and educate our clients. These other handout are still available upon request. These rules were formulated over 5 years ago, and have been available for public review/notice for many years now. In summary for this program:
- Water antibiotic products will become a prescription item. Most all of the over the counter (OTC) water medicines will not be available without a prescription. When such a product is dispensed for a food animal the antibiotic package is to be used on that animal(s) only, and if you want to use the remaining product on another animal or species you need to first contact us per the VFD rules. You do not need to discard the package after treating; keep until the package expiration date occurs if properly stored. If there are any OTC labeled antibiotics for food or water leftover from 12/2016, per the list in #3 below, on 1/1 they became a prescription/VFD product and the producer cannot use them unless they have an Rx/VFD. It can be noted that a VFD is used for medicated feeds, etc and the water antibiotics are instead a prescription (Rx) items; overall the difference is minor except the paperwork since most of the water medicines will require a VFD. If the water or another prescription item is mixed into the flock or herd’s food then it also now becomes a VFD.
- All animals that produce food products (meat, milk, eggs, honey) are covered under the VFD rulings. This will include someone with only one animal that is a pet of a food animal species (i.e. a pot belly pig, backyard chickens and pet rabbits are species involved with VFD’s).
If you are a producer one of the better education websites is globalvetlink.com. At this free site there are audio-visual presentations for beef, dairy, swine, poultry and fish. We also have information on bees, upon request. It does not matter if there is only one animal (i.e. a 4-H lamb) or a large dairy, the rules are the same for all. If you have not already received one of our VFD log sheets, we encourage you to stop by and obtain one.
- For a VFD approval, only the products labeled for that animal species can be utilized; any “off label usage” with a different brand is not allowed. The dosage has to be the same as on the label. There cannot be any extra-label formulations or dosages at all. Antibiotics cannot be used anymore to improve feed efficiency. There also cannot be any mixing of another product or drug into that feed, unless it comes as a premix that has such label approval; there are currently only 4 such combination products as FYI. Since the 1990’s there was only one VFD antibiotic, the list grew to 4x in 2015 that required the VFD paperwork, and the list of the antibiotics are approved for use in medicated feeds in 2015 were amoxicillin, ampicillin, avilamycin, chlortetracycline, cloxacillin, dihydrostreptomycin, florfenicol, gamithromycin, gentamicin, lincomycin, neomycin, ormetoprim, oxytetracycline, penicillin, pirlimycin, spectinomycin, sulfadimethoxine, sulfamerazine, sulfamethazine, sulfaquinoxaline, tildiprirosin, tilmicosin, tulathromycin, tylosin, tylvalosin and virginiamycin as FYI. A few of these antibiotics will be removed before 1/1/2017 as the manufacturer may determine the product is not needed anymore, they have better medicines available, etc. It is expected that only 15 or so of the above listed feed antibiotics will be commonly used in 2017 for VFD feed use and some will be reclassified as water antibiotics for a prescription (Rx) use.
The water soluble products in 2015 were erythromycin, gentocin, neomycin, penicillin, lincomycin, oxytetracycline, spectinomycin, sulfadimethoxine, sulfaquinoxaline, tetracycline, and tylosin. There are a few medically non-important antibiotics in humans, such as bacitracin, BMD (bacitracin methylene disalicylate) and tiamulin which do not require a VFD. The intent of VFDs is to reduce the resistance of bacteria to antibiotics by unintentional overuse, misuse of the wrong antibiotics, etc.
Some of the minor food animal species, such as goats, camelids (milk) and rabbits, do not have any VFD products that are approved. Fortunately we can utilize the prescription water medicines that are available. There are also very few of the VFD products are able to be used in bison, ratites, sheep, yaks, etc. It should be noted that if you mix a prescription water soluble product into food for herd or flock medication, it becomes a VFD. With bees it probably does not really matter if you call it a prescription or a VFD, yet VFD forms need to be filled out for honeybees. It unfortunately takes a veterinarian at least 20 minutes more time to fill out a VFD than to prescribe a controlled narcotic substance for a patient.
- The VFD and state laws require that there be a current client-veterinarian relationships; similar to any prescription item. The VFDs have additional requirements that the veterinarian has knowledge and has visited the premises where these medicated feed products will be fed. We cannot issues a VFD with a moment’s notice to any flock or herd that does not have a current exam on file. For decades we have sent out periodic fecal exam reminders for strategic deworming, and now the response to those reminders is more important than ever. As FYI dewormers and insecticides are not covered under these FDA-VFD rules, unless mixing a dewormer or insecticide/IGR in with medicated VFD feed, etc. For species of animals that we have not seen, we advise a fecal exam now, as we cannot ever consider a VFD for a patient/species that we have never seen, have not had had some exam and/or an active file for that animal species.
The sick animal treatment and prescription medications or oral/water/injection antibiotics for individual animals will essentially be the same as before, unless there is an antibiotic medicated food involved or a whole herd/flock Rx.
- The VFD paperwork will require you to keep that paperwork/FVD form in a file for 2 years; do not toss these as there will be some periodic visitations by a federal official to spot check on specific types of operations and the various species that are involved in food animal production. If you move the animals during the treatment time period we need to be notified.
- If you have any unused VFD drug/feed you do not need to destroy it. The producer cannot use that excess VFD product until they contact their veterinarian for another VFD. If you have a VFD product you cannot sell/give it to another party at all, unless you are a VFD distributor/feed mill. Unfortunately if the manufacturer’s label for the VFD states to treat for 2 weeks, the veterinarian cannot authorize a VFD for a longer period of time (“extra label”) and thus that VFD will expire in 2 weeks and if a longer treatment is needed then another VFD will need to be authorized. There is a grace period between when you get a VFD and when you start to use the product, but the expiration will expire 2 weeks after starting the antibiotic in this example. You cannot get a VFD product and use it 6 months later if it seems they became sick again, or because they got better and/or you did not have time to medicate earlier and the product was not used on that herd or flock at all initially, etc; a new VFD is required. Our clinic is a registered VFD distributor.
- A VFD is only for one set of animals or pens per the description on the VFD form. If you plan to purchase the same product from two different sources, then there needs to be two different VFD forms filled out and sent out separately; we do not recommend this. There also is no “refills” if you run out of the medicine early, lost the VFD product for various reasons, etc. Phone authorizations are not allowed for VFDs. The distributor cannot substitute any product, and thus there needs to be communication between the distributor and the veterinarian; the VFD is not like a prescription slip you can take from one pharmacy to another to see who has the product in stock. Our clinic is a VFD distributor.
- For a VFD it is much more complicated that obtaining a prescription product to treat an animal (or human). We need to know the herd/flock problem being treated, the exact number of animals, their ages, their body weights if possible, the production class of animals (i.e bison, beef cattle, beef calves, calves up to 250#, calves 250-400#, growing cattle > 400#, beef cattle < 700#, beef cattle > 700#, heifer, replacement cattle, cattle on pasture, breeding cattle, lactating cattle, cattle in confinement for slaughters, veal calves, camel, dairy cattle, dairy females < 20 months, dairy heifers on pasture, dry dairy cow, non-lactating dairy cow, deer, elk, goats, goats young non-lactating, sheep, lambs, rabbis, rabbits domestic young, reindeer, sheep domestic breeding, sheep domestic growing, sheep young domestic non-lactating, swine, swine starting, swine growing, swine weaning pig < 14 weeks, swine weaner to 120#, swine 120# excluding breeding, swine feeder pigs < 250#, swine finishing, market pigs, roaster pigs, boars, sows, swine sows pregnant, chickens, chicks up to 7 days, replacement chicken, broiler, fryer, roaster, chickens < 16 weeks, chicken laying 1st 7 months, laying hen, chickens not laying eggs for human consumption, Chukar partridge, Chukar partridge chicks < 8 weeks, ducks, laying ducks, geese, quail, quail bobwhite, growing quail, quail not over 5 weeks, quail, pheasant, pheasant growing, turkey, turkey, growing, turkey meat, turkey poults < 4 weeks, turkey not laying eggs for human consumption, , other poultry, ostrich, pigeons, bees, aquatic, catfish, fresh water finfish, warm water finfish, Salmonids, salmonids fresh water, shrimp, trout, lobster), plus the exact location (address of pasture, etc not your home address unless the same, and even then which paddock if you have more than one set of animals of the same species on the same premises. This information is needed BEFORE we can consider authorizing a VFD. Animals being fed a VFD product need to be separated from other species in that herd/flock not being medicated in the food or water. Now you can understand the USDA record keeping and premise ID requirements instigated years ago for gearing up for this process; we have more on these requirements if you do not have any such premise ID, etc. Our clinic’s VFD log for the producer and the 6+ areas of information above for a VFD can be faxed to use after hours, for next business day review. If emailing ensure you call the clinic when we open the request and information is not lost in “junk mail”; please identify the subject as a VFD request. A prescription/VFD product can also be left out after hours for client pick up at the clinic with enough notice.