Article provided by the Virginia Department Of Agriculture And Consumer Services

 January 1, 2017 will significantly change the way medically important antibiotics are used in animal agriculture. In 1996, the FDA issued A Guidance for Industry (GFI) document #209 that instructs drug sponsors to change label instructions from growth promotion, feed efficiency and milk production to therapeutic prevention of disease. GFI #209 recommends the appropriate or judicious use of medically important antimicrobial drugs in food-producing animals. For drug uses that are considered necessary for assuring animal health, GFI #209 helps minimize antimicrobial resistance development by requiring veterinary oversight or consultation before or during treatment. In the case of disease prevention, the FDA believes it is important that such use is appropriately targeted to animals at risk for a specific disease and the duration of use is limited and risk-based. Drugs currently not available over the counter (OTC) or injectable drugs will not be affected. Veterinarians play an important role in animal and human health and their oversight is an integral part of the Veterinary Feed Directive (VFD) process. This will help ensure that medically important antimicrobial drugs will be used in feed according to label directions and only when appropriate to meet specific animal health needs. Under FDA’s GFI #213 it will be illegal to use medically important antibiotics for production purposes. Producers will need to obtain authorization from a licensed veterinarian to use medically important antibiotics for prevention, control or treatment of a specifically identified disease. This rule would include virtually all feed drugs except dewormers (Ivermectin, fenbendazole), ionophores (monensin, lasalocid), beta agonists (Ractopamine, Zilpaterol), coccidiostats (decoquinate, diclazuril), bacitracin zinc and other drugs not used in humans. In short, veterinarians can no longer provide anantibiotic simply because a producer wants to use it. The veterinarian can only recommend a drug in direct response to a disease challenge. The veterinarian and producer should explore whether alternative approaches could better manage existing conditions. This may include more targeted use of antibiotics based on labels revised to align with judicious use principles, alternative non-antibiotic therapeutic options, changes in management/ production practices or other interventions. A VFD is not a prescription because the law regards drugs in feed in a category separate from prescription drugs. The category was created to provide veterinary supervision without invoking state pharmacy laws for prescription drugs. The affected drugs are those that fall in any of these seven classes: aminoglycosides, lincosamides, macrolides, penicillins, streptogramins, sulfonamides and tetracyclines. The FDA is requiring that any veterinarian issuing a VFD be licensed to practice veterinary medicine and operate in compliance with appropriate state-defined veterinarian- client-patient relationship requirements (VCPR). The key elements of the VCPR are that the veterinarians engage with the client (the producer) to assume responsibility for making clinical judgments about the patient’s health; have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where the patient is managed; and provide for any necessary follow-up evaluation. VFDs will be required for each use of a drug. The FDA has approved the existing VA VCPR definition. A valid VFD will include: drug name, amount, indications for use, location, number and kind of animals, name/address/phone of veterinarian, treatment date, VFD date, feeding instructions, withdrawal time, warning and/or cautionary statements and the veterinarian’s signature. The VFD must be hand delivered, mailed or forwarded electronically to the feed mill. A commercial company (GlobalVetLink) is prepared to accept a veterinarian-initiated VFD electronically and will complete the required process for a fee. Phone-in VFDs are not allowed. While all feed additive drugs will require a VFD which allows for no extra-label use of these drugs, those drugs administered via water will require a prescription which can allow for extra-label use. The FDA intends to use a phased enforcement strategy for implementation of this final rule as OTC drugs become VFD drugs. The FDA has contracted with the Virginia Department of Agriculture and Consumer Services (VDACS) to hire veterinary consultants who will provide targeted education and training for stakeholders subject to this final rule, such as veterinarians, producers, feed mills/distributors and others. These educational and training efforts are important for supporting effective implementation and compliance with the final rule.