FDA Extends Cephalosporin Comment Period and Delays Final Rule

August 15, 2008

FDA has agreed to extend the comment period on a final rule for an order of prohibition of cephalosporin to November 1, 2008. The FDA is also delaying the effective date of this final rule to November 30, 2008.

FDA had received extension requests from various groups saying they needed additional time to examine the available evidence, consider the impact of the ruling, and provide constructive comment. After careful consideration, the agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying implementation of the final rule.

The order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals was originally announced in the Federal Register on July 3, 2008 with a 60-day comment period and a 90-day effective date for the final rule.