Extralabel Animal Drug Use; Fluoroquinolones and Glycopeptides; Order of Prohibition

Samenvatting

The Food and Drug Administration (FDA) is issuing an order prohibiting the extralabel use of fluoroquinolones and glycopeptides. The agency is issuing this order because it believes that some extralabel uses of fluoroquinolones and glycopeptides in food-producing animals are capable of increasing the level of drug resistant zoonotic pathogens (pathogens that are infective to humans) in treated animals at the time of slaughter. FDA finds that some extralabel uses of fluoroquinolone and glycopeptide drugs in food-producing animals likely will cause an adverse event, which constitutes a finding under the Animal Medicinal Drug Use Clarification Act of 1994 (the AMDUCA) that extralabel use of these drugs in food animals presents a risk to the public health. Therefore, the agency is issuing this order of prohibition.