# New Animal Drugs; Phenylbutazone; Extralabel Animal Drug Use; Order of Prohibition
> **Food and Drug Administration** · Final rule. · Published 2003-02-28 · Effective 2003-05-29 · 68 FR 9528
## Document
- **Document number:** 03-4741
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 9528
- **CFR reference:** 21 CFR 530
- **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).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/02/28/03-4741/new-animal-drugs-phenylbutazone-extralabel-animal-drug-use-order-of-prohibition)
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