Implantation or Injectable Dosage Form New Animal Drugs; Zeranol
other · Food and Drug Administration · Rule · Published 2002-02-14 · Effective 2002-02-14 · 67 FR 6866
Document
Document number
02-3681
Federal Register citation
67 FR 6866
CFR reference
21 CFR 522
Type
Rule
Action
Final rule, technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2002-02-14
Effective date
2002-02-14
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for use of a subcutaneous ear implant containing zeranol in pasture cattle for increased rate of weight gain. FDA is also amending the regulations to add the acceptable daily intake (ADI) for total residues of zeranol.