Cephalosporin Order of Prohibition Goes Into Effect

April 9, 2012 — 

The U.S. Food and Drug Administration (FDA) announced on April 6 that the order of prohibition of cephalosporins originally published on January 6, 2012 is now effective.

The order prohibits certain uses of the cephalosporin (excluding cephapirin) class of antimicrobial drugs in cattle, swine, chickens and turkeys.

FDA is taking this action to preserve the effectiveness of cephalosporin drugs for treating disease in humans. Prohibiting these uses is intended to reduce the risk of cephalosporin resistance in certain bacterial pathogens.

In its order, FDA is prohibiting what are called “extralabel” or unapproved uses of cephalosporins in cattle, swine, chickens and turkeys, the so-called major species of food-producing animals. Specifically, the prohibited uses include:

• using cephalosporin drugs 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 (e.g., cephalosporin drugs intended for humans or companion animals);
• using cephalosporin drugs for disease prevention.

The order had a comment period of 60 days that began on January 6, 2012 and closed on March 6, 2012. The FDA carefully reviewed all submitted comments and determined that the order of prohibition, as published on Jan 6, 2012, should go into effect on April 5, 2012 without further revision or delay.

[Editor's comment: What this means for swine veterinarians is that, effective immediately, cephalosporins cannot be prescribed for use in an extralabel manner except for indications not included on the label and then only at the dose, frequency, duration and route of administration described on the label. Also, cephalosporins intended for use in humans or companion animals are prohibited for use in swine as is any use for the prevention of disease.]

Source: FDA Center for Veterinary Medicine