Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-The-Counter Human Use; Final Monograph for Combination Drug Products
other · Food and Drug Administration · Rule · Published 2002-12-23 · Effective 2004-12-23 · 67 FR 78158
Document
Document number
02-32158
Federal Register citation
67 FR 78158
CFR reference
21 CFR 341
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2002-12-23
Effective date
2004-12-23
HHS docket
Docket No. 76N-052G
Abstract
The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph that establishes conditions under which over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) combination drug products are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation (tentative final monograph) and new data and information on OTC cough- cold combination drug products that have come to the agency's attention.