Last December, the Food and Drug Administration Center for Veterinary Medicine (CVM) released its final draft of Guidance for Industry (GFI) 213. This is the road map for companies to enact the voluntary actions described in GFI 209, which was released in 2012.
In GFI 209, CVM indicated it didn’t view the use of medically important antibiotics for growth promotion purposes as judicious. The agency also indicated it desires all uses of medically important antibiotics in feed or water for food animals to be under veterinary control.
As of March 2014, CVM says 25 of the 26 companies affected by these GFIs have indicated they will comply; this represents 283 product labels, which includes generic versions. What does this mean for producers?
First, what are “medically important” antibiotics? Essentially, they’re everything we use in food animals except for the ionophores (monensin, lasalocid), bacitracin, bambermycins, and the pleuromutilins (tiamulin, used in swine). By the way, the World Health Organization list includes some additional drugs, so the U.S. list may be updated in the future.
The following discussion only applies to the medically important antibiotics; at this time, I’m not aware of any CVM intent to require a veterinary feed directive (VFD) for the ionophores.
The bottom line is that use of the listed antibiotics for any purpose (prevention, control or therapy) in feed or water will require veterinary authorization in the form of a VFD or a veterinary prescription, respectively. “Feed” includes milk replacer, so the purchase of a medicated milk replacer will require a VFD. Purchase of currently over-the-counter (OTC) water medications will require a prescription. Currently available injectable OTC antibiotics (e.g., oxytetracycline, penicillin G and tylosin) will remain available as OTC, according to current and pending actions, but I expect them to be subject to similar action in the future.
I strongly urge these OTC antibiotics only be used with guidance from your veterinarian. Any use of these injectable products other than specified on the label requires a veterinary prescription, including using penicillin G at routine doses rather than the dose specified on the label.
When will this happen? GFI 213 stipulated a three-year timeline that began in March 2014. The changes are based on label changes for individual products, so we may see some changes before that depending on when new labels come out.
CVM has reserved the option of extending this timeline, depending on how things move along. Companies also have the ability to demonstrate that growth promotion- label regimens also result in disease prevention or control, and then may alter the label so that the same label regimen now has the new claim. This will require substantial additional research to show this activity, however.
What a new VFD will look like is still being determined. CVM released a proposed rule for comment and is now continuing to work with veterinary and food-animal producer organizations to refine the requirements. One proposed change is that the definition of veterinary oversight lies with the local jurisdictions (states). The states are starting to work on this definition, figuring out just exactly how it will work. You will likely be getting news and updates from your organizations.
Our industry’s ability to transition to this new system will require active cooperation from two parties — veterinarians and producers. There is the opportunity for increased cooperation in drug use and disease avoidance, as veterinarians and producers have more reasons to come together in relation to animal health.
Lots of information will be coming out over the next few years on this topic, and we’ll undoubtedly be doing some things differently. If not already in place, it would be wise for producers to build and expand the relationships necessary to manage antibiotic use in these applications.
Mike Apley, DVM, Ph.D., is a professor in clinical sciences at Kansas State University in Manhattan.
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