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December 11, 2013
11:36 EDTZTS, MWIVFDA takes significant steps to address antimicrobial resistance
The U.S. Food and Drug Administration today is implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs. In a final guidance issued today, the FDA lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications. The plan also calls for changing the current over-the-counter status to bring the remaining appropriate therapeutic uses under veterinary oversight. Once a manufacturer voluntarily makes these changes, its medically important antimicrobial drugs can no longer be used for production purposes, and their use to treat, control, or prevent disease in animals will require veterinary oversight. The FDA is asking animal pharmaceutical companies to notify the agency of their intent to sign on to the strategy within the next three months. These companies would then have a three-year transition process. Reference Link
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