Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Partial Final Rule for Combination Drug Products Containing a Bronchodilator; Correction
other · Food and Drug Administration · Rule · Published 2001-10-19 · Effective 2001-10-19 · 66 FR 53088
Document
Document number
01-26315
Federal Register citation
66 FR 53088
CFR reference
21 CFR 310
Type
Rule
Action
Final rule; correction.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-10-19
Effective date
2001-10-19
HHS docket
Docket No. 76N-052G
Abstract
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of September 27, 2001 (66 FR 49276). The document issued a final rule establishing that cough-cold combination drug products containing any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic- antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient are not generally recognized as safe and effective and are misbranded for over-the-counter (OTC) use. The document published with two inadvertent errors. This document corrects those errors.