[Federal Register Volume 59, Number 205 (Tuesday, October 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26376]
[[Page Unknown]]
[Federal Register: October 25, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 524
[Docket No. 94N-0202]
Nitrofurazone Solution; Removal of Regulation
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is removing the
regulation which reflects approval of three new animal drug
applications (NADA's) providing for the use of nitrofurazone solution
drug products. Additionally, approval of those portions of a fourth
NADA (sponsored by SmithKline Beecham Animal Health) which provide for
use of nitrofurazone solution product is also being withdrawn, but that
approval is not codified. All four sponsors submitted written requests
that the agency withdraw the approvals.
EFFECTIVE DATE: November 3, 1994.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0749.
SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this
issue of the Federal Register, FDA is withdrawing approval of three
NADA's and those portions of NADA 6-475 providing for the use of
nitrofurazone solution. The withdrawals of approval were requested in
writing by the sponsors after FDA informed them that new information
establishes that the labeled directions for use of the 0.2 percent
nitrofurazone solutions have not been followed in practice. The NADA's
are:
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Sponsor NADA No.
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SmithKline Beecham
Animal Health, 1600
Paoli Pike, West
Chester, PA 19380 6-475
Veterinary Laboratories,
Inc., 12340 Santa Fe
Dr., Lenexa, KS 66215 121-559
Fermenta Animal Health
Co., 10150 North
Executive Hills Blvd.,
Kansas City, MO 64153 126-023
Med-Pharmex, Inc.,
Biomed Laboratories,
325 East Arrow Hwy.,
San Dimas, CA 91773 126-950
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The NADA's provide for over-the-counter use of 0.2 percent
nitrofurazone solution on dogs, cats, and horses for prevention or
treatment of topical bacterial infections, and prescription use for
female equine genital tract infections and impaired fertility due to
strains of certain bacteria. This document removes 21 CFR 524.1580d,
the regulation which reflects the approvals.
List of Subjects in 21 CFR Part 524
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 524 is
amended as follows:
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 524.1580d [Removed]
2. Section 524.1580d Nitrofurazone solution is removed and
reserved.
Dated: September 21, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-26376 Filed 10-24-94; 8:45 am]
BILLING CODE 4160-01-F