Changes in regulations regarding antibiotic use in livestock are happening. In January 2017, limitations on the use of medically important antibiotics — which will be permitted only for necessary therapeutic use — as well as in how the antibiotics are accessed for use, will become fully implemented.
The changes, due to increasing concerns about antimicrobial resistance in livestock and in humans, are designed to insure that antibiotics “are used as judiciously as possible,” Dr. Craig Lewis, of the Food and Drug Administration’s Center for Veterinary Medicine, said. Lewis was a presenter in a recent National Cattlemen’s Beef Association (NCBA) webinar, available at www.beefusa.org . The regulations discussed are contained in the FDA Guidance for Industry #209 and its follow up document, #213.
The drugs affected by these regulations are those considered medically important, and which are currently available over the counter as a feed or water additive. Those not currently available over the counter are not impacted, nor are injectable drugs.
Veterinary feed directive
Regulations have been put in place which require increased involvement by veterinarians in the use of these drugs. Instead of OTC availability, drugs added to water will require a prescription, and those added to feed will require a Veterinary Feed Directive (VFD). In addition, off-label uses of VFD drugs are not allowed.
“Any antimicrobials for use in or on feed requires a VFD,” Dr. Lewis emphasized.
The VFD has been in place for several drugs in the high potential for risk category. The new regulations are expanding the drugs which will require VFD, but reclassifying VFD drugs so that they are not automatically all considered high risk. High risk drugs require the manufacturer to be licensed to handle the drug in its most concentrated, or “Type A,” form. Any drug which, at the lowest levels of use in any species requires a withdrawal period, or those which have a no residue, zero tolerance restriction, due to carcinogenic concerns, will be in the high risk category.
Manufacturers have until December 2016 to implement labeling changes, as well as licensing and distribution changes required by the regulations. Combination feed products which involve at least one ingredient covered under the VFD will be regulated, and any new drug combinations will need approvals, for which there are specific guidelines.
The regulations will also be reformulating existing VFD requirements to make them more efficient and comprehensive. A VFD has several components. The first requirement is that there is an existing Veterinary-Client Patient Relationship. (VCPR). This requires that the veterinarian assumes responsibility for the herd’s health. He or she will have knowledge of the herd and of the farm’s practices, and will provide follow up care and evaluation.
A VFD will include the farm name, and the veterinary contact information. The species and the production class of the animals which will be given the feed additive must be included, the approximate number of animals to be fed, as well as the age, weight range and location of animals included in the VFD. The VFD will carry an expiration date, as well as a duration of use provision.
The expiration date states the last day which the feed can be fed to any animal on the farm. The duration of use defines the length of time any given animal can be fed the drug. If the expiration date occurs before the duration of use for an animal ends, the VFD will need to be renewed before the farmer can continue with the feed additive. No open reorders are currently allowed, and there are restrictions regarding refills.
The VFD must also include an affirmation of intent statement. This states whether the VFD is for the authorized single ingredient drug ingredient only, for a specific combination containing the drug, or for any approved combination product containing the drug. This is to insure that illegal, unapproved drug combinations are not being used.
VFD’s are to be kept on file for two years, and a copy must be kept by all parties involved. They may be electronic or paper, and require the veterinarian’s signature.
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. Prescription drugs can allow for extra-label use as long as the Animal Medical Drug Use Clarification Act regulations are met.
“What they can prescribe is defined by the label,” Mike Apley, of Kansas State University said.
In addition, veterinarians can no longer provide a drug simply because a farmer wants to use it. The veterinarian can only recommend a drug in direct response to a disease challenge. These drugs are not meant to be used for a long-term regiment, and veterinarians will have to consider resistance issues. The need, the drug efficacy, and any withdrawal requirements prior to slaughter will all play important roles in veterinary decision making.
“This helps us understand what will be going through your veterinarian’s mind as they consider the potential application of the drug,” Apley said.
Veterinarians have been actively engaged with the FDA throughout the development of the VFD regulations. There have also been training programs, and ongoing dialogues between the FDA, veterinarians and feed manufacturers and nutritionists.
Apley led attendees in a quiz regarding whether or not certain common practices would now require a VFD. Some, such as oxytetracycline in milk replacer, were obviously feed additives which will — as of January 2017 — require a VFD. Others, such as chlortetracycline in feed for treating foot rot will no longer be available, as this is an extra-label use of a medically important drug added to feed. Still others, such as monensin in a feed ration, will not require a VFD, and is an allowed use, because it is not considered a medically important antibiotic.
“It all revolves around the label,” Apley said. “You and your veterinarian will need to understand the specifications of use.”
The use of medically important antibiotics as livestock feed additives will no longer be routine. Beginning Jan. 1, 2017, all such drugs will be limited to labeled use only, will no longer be available in OTC products, and will require a VFD in order to obtain them. Designed to provide oversight and limit irresponsible use of medically important antimicrobial drugs, these regulations will require livestock producers to re-evaluate their current herd health plans, and perhaps to work more closely with their veterinarians to achieve the best outcomes without the regular use of these regulated drugs.