New antibiotic rules for 2017
The use and distribution of antibiotics in animal agriculture is changing and producers of all sizes need to begin preparing to adapt in the coming year. Focusing on the one-health concept of combating antibiotic resistance, the United States Food and Drug Administration (FDA) is working to ensure the judicious use of humanly medically important antibiotics. Changes include eliminating the growth promotion use of human medically important antibiotics and expanding the list of feed-grade antibiotics classified as Veterinary Feed Directive (VFD) drugs. Historically, a majority of feed-grade antibiotics used in or on animal feeds have been available to producers over-the-counter, without approval from a veterinarian. By Jan. 1, 2017 the FDA will move all human medically important feed-grade antibiotics to the VFD drug process.
In addition, the FDA has aligned with drug companies to voluntarily revise label claims for antibiotics falling under the VFD regulation. Sponsors are removing growth promotion and feed efficiency as allowable uses, effectively preventing veterinarians from writing VFD orders for these purposes.
What does this mean for animal agriculture?
Farmers must work with a licensed veterinarian with whom they have an established veterinarian-client-patient relationship (VCPR) in order to receive permission to order and use feed containing a VFD drug. The veterinarian’s primary role is to advise and guide the producer (the client) in determining which medications are appropriate for their animals (the patients). This relationship must be established and recognized by the veterinarian prior to any VFD order being written. Feed distributors will require a valid VFD, provided by the veterinarian, prior to supplying customers with the regulated feed product. VFDs will need to be renewed every 6 months, based on renewal guidelines set by FDA.
So far, only a small number of antibiotics (tilmicosin, florfenicol, and avilamycin) have been restricted in feed-grade use under a VFD. While some industries, like swine, are very familiar with the VFD process because of the common use of Pulmotil® (tilmicosin), many producers have never had to use the VFD process to acquire antibiotics. With the expansion, this will soon change as nearly all sectors of animal agriculture will be affected, including honey bees and other “minor-use” species.
Are all antibiotics affected?
It is important to note not all antibiotics will be considered VFD drugs (Figure 1). The use of injectable antibiotics will not be affected. At this time, FDA has only moved antibiotics essential to human medicine and being fed to animals to VFD status. Also, as a part of the new FDA changes, water soluble antibiotics, which are important to human medicine, will now require a prescription from a veterinarian. This transition of water soluble drugs will include Aureomycin® Water Soluble Concentrate (Chlortetracycline).
Some other key components of the VFD process for the producer are:
- You can fill a VFD order at any mill, retailer or other establishment listed as a distributor with the FDA, a complete list can be found here.
- In order for feed mills to fill requests for feed with VFD drugs, a current VFD order must be on file.
- A Veterinarian can write a VFD order that may only apply for up to six months. The FDA will publish a list of specific products that are allowed VFD renewal.
- The expiration date on the VFD order is the last date the VFD feed can be fed.
- A copy of the VFD order must be kept by the producer for two years from the date of writing. If the farm is inspected by the FDA, producers must be able to provide VFD orders, when requested.
- Labels of VFD drugs must have the following statement: “Caution: Federal law restricts medicated feed containing this VFD drug to use by or on the order of a licensed veterinarian.”
- The FDA is also maintaining a list of VFD drugs on their website. The most up-to-date version is available online.
As the limitations on animal health products increase, such as requiring veterinary feed directives and less feed-grade antibiotics are available through retail outlets, producers will find themselves seeking veterinary guidance either for a VFD, alternative medications or appropriate vaccine protocols. Increased emphasis on improvements to management practices such as biosecurity, housing and animal flow to reduce the need for antibiotic use while maintaining a profit are excellent opportunities for livestock producers. Please do your part to understand the VFD requirements. As a producer, you play a vital role in treating animals and protecting food safety.
For more information and resources regarding the changes and responsible antibiotic use on the farm, please visit the State of Michigan VFD website.
Figure 1. Present listing of in and on feed antibiotics outside of VFD directive.*
Ionophores (i.e. lasalocid and monensin) Decoquinate
*Unless used in combination with a VFD drug.