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

other · Food and Drug Administration · Rule · Published 1997-05-22 · Effective 1997-08-20 · 62 FR 27944

Document

Document number
97-13677
Federal Register citation
62 FR 27944
CFR reference
21 CFR 530
Type
Rule
Action
Final rule; order of prohibition.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-05-22
Effective date
1997-08-20
HHS docket
Docket No. 97N-0172

Abstract

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.

Source

Authoritative
Federal Register document
Machine
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