Best of BoVet: FDA Issues Progress Report on Antimicrobial Use

As we approach the end of 2016, we want to look back on the top 10 articles from Bovine Vet this year. Read the number



The FDA's Center for Veterinary Medicine (CVM) this week issued its fourth progress report outlining its actions promoting judicious use of antimicrobials in livestock. The FDA's efforts in this area have focused on reducing the use of medically important antimicrobials administered through feed, particularly those used to improve animal performance, and to bring other uses of those products under the oversight of veterinarians.

To address those goals, the FDA issued its

Guidance for Industry 213

in December of 2013. That guidance calls on drug sponsors, by December 2016, to voluntarily remove indications for use related to growth promotion from product labels of medically important feed-grade antimicrobials. According to the FDA/CVM, there were 293 applications initially affected by Guidance 213. All of the affected drug sponsors have indicated they intend to comply with the voluntary guidance by the December deadline, and some already have begun implementing the recommended changes. Three applications have been converted from over-the-counter to prescription dispensing status, production indications have been withdrawn from one application and 35 affected applications have been completely withdrawn.

Also, in June 2015, the agency issued its final

veterinary feed directive (VFD) rule, which places the use of medically important antimicrobials, used in feed for prevention, control or treatment of disease, under the oversight of veterinarians. Many of those products have been available for over-the-counter purchase. Once the changes recommended by Guidance 213 are fully implemented, medically important antimicrobials intended for use in animal feed will be limited to use under a VFD order issued by a licensed veterinarian. The rule also specifies that veterinarians can issue VFD orders only in the context of a valid veterinarian-client-patient relationship (VCPR).

In December 2015, FDA another document, draft Guidance for Industry #233, which is titled "Veterinary Feed Directive Common Format Questions and Answers." The draft guidance is intended to help drug sponsors meet certain requirements for VFD drug approval. FDA began accepting public comments on draft Guidance 233 on December 1, 2015, and the comment period will continue until January 30. To electronically submit comments to the docket, visit

and type FDA-2010-N-0155 in the search box.

For these efforts to provide much value to the public, the FDA and other agencies will need to quantify their effects on antimicrobial use and, ultimately, on antimicrobial-resistance trends. Toward that goal, in May 2015 the agency proposed revisions to its annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals in order to obtain estimates of sales broken out by major food-producing species.

Also the FDA, USDA and the Centers for Disease Control and Prevention are working together to develop and implement a plan to collect additional data on estimated antibiotic use in food-producing animals. The agencies held a public meeting in September 2015, and intend to finalize this data collection plan in 2016.


Latest News

12 Ways to Prevent the Spread of Disease in Feedlots

Sound management, health protocols and facilities maintenance can help achieve the ultimate goal of keeping cattle healthy and productive.

BQA Low Stress Cattle Handling Principles

Sound care and handling practices, based on years of experience and research are known to impact the well-being of cattle, individual animal health and herd productivity.

Idaho Dairy Demo Center Planned

The University of Idaho is building a massive dairy research center focused on the industry’s sustainability.

Is Grass-Fed Beef Healthier or Better for the Environment?

Oklahoma State University meat scientist Gretchen Mafi has studied the scientific differences between beef that comes from animals finished on a grain diet versus those animals finished on grass.

How To Give a Calf Electrolytes, The Dehydration Lifeline

Electrolytes can serve as a needed boost for a scouring calf. Here's a look at what’s in electrolyte products, how much electrolytes should be given and a few ways and tips on how to give electrolytes to a calf.

National Institute for Animal Agriculture to Host Equine Industry Leaders

Equine leaders will discuss the importance and sustainability of the working ranch horse at NIAA’s Annual Conference in April.