Topical Drug Products for Over-the-Counter Human Use; Products for the Prevention of Swimmer's Ear and for the Drying of Water-Clogged Ears; Partial Stay of Final Rule
other · Food and Drug Administration · Rule · Published 1995-08-16 · Effective 1995-06-22 · 60 FR 42435
Document
Document number
95-20315
Federal Register citation
60 FR 42435
CFR reference
21 CFR 310
Type
Rule
Action
Final rule; partial stay of regulation.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1995-08-16
Effective date
1995-06-22
HHS docket
Docket No. 77N-334S
Abstract
The Food and Drug Administration (FDA) is staying part of a final rule that established that any over-the-counter (OTC) topical otic drug products for the prevention of swimmer's ear or for the drying of water-clogged ears is not generally recognized as safe and effective and is misbranded. This action, which is being taken in response to new clinical data and a petition for stay of action, applies only to topical otic drug products for the drying of water- clogged ears. This action is part of the ongoing review of OTC drug products conducted by FDA.