Antiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph
other · Food and Drug Administration · Rule · Published 2003-06-09 · Effective 2004-12-09 · 68 FR 34273
Document
Document number
03-14140
Federal Register citation
68 FR 34273
CFR reference
21 CFR 310
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-06-09
Effective date
2004-12-09
HHS docket
Docket No. 78N-0064
Abstract
The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) antiperspirant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, issued as a tentative final monograph (TFM), and all new data and information on antiperspirant drug products that have come to the agency's attention.