New Animal Drugs for Use in Animal Feeds; Oxytetracycline; Neomycin
other · Food and Drug Administration · Rule · Published 2009-08-13 · Effective 2009-08-13 · 74 FR 40723
Document
Document number
E9-19414
Federal Register citation
74 FR 40723
CFR reference
21 CFR 558
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-08-13
Effective date
2009-08-13
HHS docket
Docket No. FDA-2009-N-0665
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pennfield Oil Co. The supplemental NADA provides for the use of fixed-combination Type A medicated articles containing oxytetracycline and neomycin sulfate to formulate two-way, fixed-combination drug Type B and Type C medicated feeds for chickens, turkeys, swine, cattle, and sheep. This approval reflects 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.