Extralabel Cephalosporin Ban Goes Into Effect

Extralabel uses of the cephalosporin class of antimicrobial drugs has officially been put under federal prohibition by the FDA.

The federal prohibition on extralabel uses of the cephalosporin class of antimicrobial drugs in major species of food-producing animals went into effect yesterday, the U.S. Food and Drug Administration reported today.

The FDA order prohibits extralabel uses of all cephalosporins, excepting cephapirin, in cattle, swine, chickens and turkeys, including:

• 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 FDA enacted the prohibition to preserve the effectiveness of cephalosporin drugs for treating humans by reducing the risk of cephalosporin resistance in certain bacterial pathogens, the agency said. The order does not limit the use of cephapirin, because the FDA does not believe the drug contributes significantly to antimicrobial resistance.

In 2008, the FDA issued a similar order, but revoked it prior to implementation to consider remarks made during the comment period. In January 2012, the FDA issued the current order and once again called for comments. After reviewing those comments, the agency determined that the order of prohibition should go into effect on April 5, 2012, without further revision.

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