# Antiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph
> **Food and Drug Administration** · Final rule. · Published 2003-06-09 · Effective 2004-12-09 · 68 FR 34273
## Document
- **Document number:** 03-14140
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 34273
- **CFR reference:** 21 CFR 310
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/06/09/03-14140/antiperspirant-drug-products-for-over-the-counter-human-use-final-monograph)
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