Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; OTC Nasal Decongestant Drug Products; Partial Stay of Final Rule; Enforcement Policy
other · Food and Drug Administration · Rule · Published 1996-03-08 · Effective 1995-08-31 · 61 FR 9570
Document
Document number
96-5444
Federal Register citation
61 FR 9570
CFR reference
21 CFR 310
Type
Rule
Action
Final rule; partial stay of regulation; enforcement policy.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1996-03-08
Effective date
1995-08-31
HHS docket
Docket No. 76N-052N
Abstract
The Food and Drug Administration (FDA) is staying part of a final rule that established that certain over-the-counter (OTC) nasal decongestant drug products are not generally recognized as safe and effective and are misbranded. This action is being taken in response to a citizen petition for a stay of enforcement of regulatory action against OTC nasal decongestant drug products containing the active ingredient l-desoxyephedrine. The agency is also providing labeling requirements for OTC topical nasal decongestant drug products containing l-desoxyephedrine. This action is part of the ongoing review of OTC drug products conducted by FDA.