FDA to prohibit certain uses of cephalosporin antibiotics in food animals
The new order, FDA says, takes into consideration “substantial public comment the agency received on a similar order it issued in 2008, but revoked prior to implementation.” FDA contends the new rules will help preserve the effectiveness of cephalosporins for treating human diseases by reducing the risk of cephalosporin resistance in certain bacterial pathogens.
The order prohibits “extra-label” or unapproved uses of cephalosporins in cattle, swine, chickens and turkeys. Specifically, the new rule bans the use of cephalosporins at unapproved dose levels, frequencies, durations or routes of administration; using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (such as cephalosporin drugs intended for humans or companion animals); or using cephalosporin drugs for disease prevention.
The 2008 order, which was previously issued and revoked by FDA, banned extra-label uses of cephalosporins in food-producing animals without exceptions. FDA says the order does not limit the use of cephapirin, an older cephalosporin that FDA does not believe contributes significantly to antimicrobial resistance.
Veterinarians will still be able to use or prescribe cephalosporins for limited extra-label use in cattle, swine, chickens or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label, according to FDA. Veterinarians may also use or prescribe cephalosporins for extra-label uses in minor species of food-producing animals, such as ducks or rabbits.
"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, FDA's deputy commissioner for foods.
Comments on the new order may submitted Jan. 6 to March 6.
The new order of prohibition's comment period is from Jan. 6 to March 6, 2012. To comment on the order of prohibition, visit regulations.gov and enter FDA-2008-N-0326 in the keyword box.
FDA will consider the comments prior to implementation of this order of prohibition on April 5, 2012.