New Animal Drugs; Phenylbutazone; Extralabel Animal Drug Use; Order of Prohibition
other · Food and Drug Administration · Rule · Published 2003-02-28 · Effective 2003-05-29 · 68 FR 9528
Document
Document number
03-4741
Federal Register citation
68 FR 9528
CFR reference
21 CFR 530
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-02-28
Effective date
2003-05-29
HHS docket
Docket No. 03N-0024
Abstract
The Food and Drug Administration (we) is issuing an order prohibiting the extralabel use of phenylbutazone animal and human drugs in female dairy cattle 20 months of age or older. We are issuing this order based on evidence that extralabel use of phenylbutazone in female dairy cattle 20 months of age or older will likely cause an adverse event in humans. We find that such extralabel use presents a risk to the public health for the purposes of the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA).