Animal Drugs, Feeds, and Related Products; Eprinomectin; N-Methyl-2-Pyrrolidone
other · Food and Drug Administration · Rule · Published 2011-11-25 · Effective 2011-11-25 · 76 FR 72617
Document
Document number
2011-30329
Federal Register citation
76 FR 72617
CFR reference
21 CFR 500
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2011-11-25
Effective date
2011-11-25
HHS docket
Docket No. FDA-2011-N-0003
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Merial Ltd. The NADA provides for the veterinary prescription use of eprinomectin by injection for the treatment and control of internal and external parasites of cattle on pasture with persistent effectiveness. The current tolerance for the marker residue for total residues of eprinomectin in edible tissues of cattle is being lowered. The method of detection for residues of the carcinogenic excipient n-methyl-2- pyrrolidone (NMP) in edible tissues of cattle is also being codified.