← HHS Federal Register rules

New Animal Drugs for Use in Animal Feeds; Bacitracin; Nitarsone; Zoalene

other · Food and Drug Administration · Rule · Published 2006-03-31 · Effective 2006-03-31 · 71 FR 16222

Document

Document number
06-3122
Federal Register citation
71 FR 16222
CFR reference
21 CFR 558
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-03-31
Effective date
2006-03-31
HHS docket
Docket No. 2003N-0324

Abstract

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of three supplemental new animal drug applications (NADAs) filed by Alpharma, Inc. Two of the supplemental NADAs provide for the use of approved, single-ingredient Type A medicated articles containing bacitracin methylene disalicylate and zoalene, with or without roxarsone, to formulate two-way or three- way combination drug Type C medicated feeds for replacement chickens. The third NADA provides for the use of bacitracin zinc and nitarsone single-ingredient Type A medicated articles for two-way combination Type C medicated feeds for growing turkeys. These approvals reflect FDA's effectiveness conclusions, which relied on the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Group's evaluation of the effectiveness of these drugs when used in animal feed as single ingredients.

Source

Authoritative
Federal Register document
Machine
JSON-LD · Markdown