# 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
> **Food and Drug Administration** · Final rule; partial stay of regulation; enforcement policy. · Published 1996-03-08 · Effective 1995-08-31 · 61 FR 9570
## Document
- **Document number:** 96-5444
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 61 FR 9570
- **CFR reference:** 21 CFR 310
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1996/03/08/96-5444/cold-cough-allergy-bronchodilator-and-antiasthmatic-drug-products-for-over-the-counter-human-use-otc)
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