Cephalosporin is commonly used to treat human cases of pneumonia, skin infections and strep throat. In cattle it is used for treatment of respiratory conditions and foot rot.

The FDA said the extralabel ban on livestock will preserve the effectiveness of the drug for human medications.

"We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals," said Michael R. Taylor, deputy commissioner for foods.

FDA specified in its online documents that the ban restricts the use of “biobullets in beef cattle,” as well as its preventative use in major species of food production animals. The order also bans using cephalosporin “at unapproved dose levels, frequencies, durations, or routes of administration.”

But cephalosporin drugs will continue to be used to treat or control extralabel diseases, as long as the use “adheres to a labeled dosage regimen” and the “dose, route, frequency and duration” specified on the label.

The move is the latest in the FDA’s examination into antimicrobial resistance, when a drug loses its ability to control bacterial growth due to overuse. Health welfare groups have criticized livestock producers for the use of certain antibiotics in preventatively treating cattle and using it in feed to improve the rate of gain.

Mike Apley of Kansas State University, a DVM and professor of production medicine and clinical pharmacology, said cephalosporins are “still a reliable drug for animal conditions” and “still used extensively in the beef industry.”

“It’s not being removed and we can still use it as labeled,” he said. “We just can’t change the actual regimen, duration and registry. They’ve restricted how far off label you can go.”

Cephalosporins are only used for therapeutic use in individual animals, according to the FDA, and are not used for growth promotion in feed. They were introduced for human clinical use in 1964.

Approved cephapirin products in food-producing animals will still be allowed, the FDA said, because those specific drugs are no longer approved for use in humans. Apley said cephapirin drugs are still effective for treating cattle mastitis.

Apley said producers should expect to see some work on the definitions used in the cephalosporin labels, as they relate to control of respiratory disease.

“When you have a group of animals that are at high risk for disease, and some incubated, there is a label for that respiratory disease,” Apley explained. “If some of those livestock are still displaying or incubating the disease, that’s still going to be completely appropriate (to use the antibiotic).”

The FDA’s decision on cephalosporins, Apley said, mirrors previous policies that limited extralabel use of fluoroquinolones.

The message, Apley said, is for producers to do things right with closer scrutiny of antibiotic usage. Regulatory agencies such as the FDA will keep tighter watch on drugs used in veterinary and human care. Apley said that over time the agency’s objectives will be to transition toward requiring a vet’s involvement in all antibiotics given to food animals, and strictly phasing out the use of antibiotics as food growth promotants.

“In this case by going the extralabel authority route, limiting to use off label, was a direct way to reduce the cephalosporins in food animals. They’ll monitor to see how things continue to change. It could be the first step or the only step, we’ll have to wait and see how they interpret monitoring data.” 

The rule has a comment period that began on Jan. 6, 2012 and closes on March 6, 2012. To comment on the order, visit www.regulations.gov and enter FDA-2008-N-0326 in the keyword box.

Following the comment period, the FDA will consider the comments prior to the order of prohibition going into effect on April 5, 2012.