January 4, 2012

1 Min Read
FDA Issues Order Restricting The Use of the Drug Ceftiofur

 

The Food and Drug Administration (FDA) has issued an order restricting the use of cephalosporin antibiotics, which are given to food-producing animals, according to a news release from the American Meat Institute.

Under the new rules, extra-label use of ceftiofur will only be allowed for use to treat or control, but not prevent a disease, and must be used at the labeled dose, frequency, duration and route of administration approved for that species and production class, according to FDA.

These new rules apply to major species such as cattle, swine, chickens and turkeys.

FDA’s ruling today significantly revises a 2008 rule by the agency that called for prohibiting all extra-label drug use of cephalosporins; that proposal was later withdrawn.

Cephalosporin antibiotics are used to treat pneumonia, skin infections and meningitis, among other diseases, in humans.

“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,” says Michael R. Taylor, deputy commissioner for Foods.

The final rule is to be published Friday in the Federal Register, with a comment period that will begin on Jan. 6, 2012 and close on March 6, 2012. To comment on the order, visit www.regulations.gov and enter FDA-2008-N-0326 in the keyword box. Comments will be considered prior to the order of prohibition going into effect on April 5, 2012.

For more information about this announcement, visit  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm285704.htm?source=govdelivery

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