Rulemaking History for OTC Antifungal Drug Products

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Rulemaking History for OTC Topical Antifungal Drug Products
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Final Monograph (21 CFR part 333 subpart C):
Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Topical Antifungal Drug Products

OTC Topical Antifungal Drug Products found on this page:

Original Active Ingredients and Labeling
Nonmonograph Ingredients
Clotrimazole
Diaper Rash
Indications
Treatment of Tinea Pedis
Vaginal Drug Products

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**Topical Antifungal Drug Products: Original Active Ingredients and Labeling**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	3/23/1982	47FR12480
Correction	4/23/1982	47FR17575
Correction	12/7/1982	47FR54981
Proposed Rule	Date	FR Citation
Tentative Final Monograph	12/12/1989	54FR51136
Correction	1/9/1990	55FR797
Correction	1/22/1990	55FR2202
Final Rule	Date	FR Citation
Final Rule: Nonmonograph labeling claims	9/2/1993	58FR46744
Final Monograph	9/23/1993	58FR49890

**Topical Antifungal Drug Products: Nonmonograph Ingredients**
Proposed Rule	Date	FR Citation
Proposed Rule: Classifies category II and III ingredients without data as non-monograph	8/25/1992	57FR38568
Correction	9/8/1992	57FR40944
Technical Amendment: Correct an ingredient name	10/1/1992	57FR45295
Correction	11/9/1992	57FR53300
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as non-monograph	5/10/1993	58FR27636

**Topical Antifungal Drug Products: Clotrimazole**
Proposed Rule	Date	FR Citation
Proposed Rule: Adds clotrimazole as GRASE active ingredient	5/29/2001	66FR29059
Final Rule	Date	FR Citation
Final Rule	2/8/2002	67FR5942

**Topical Antifungal Drug Products: Diaper Rash**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	9/7/1982	47FR39464
Extension of Comment Period	12/28/1982	47FR57738
Proposed Rule	Date	FR Citation
Proposed Rule: Classifies diaper rash claim as nonmonograph	6/20/1989	55FR25240
Correction	7/19/1990	55FR29453
Final Rule	Date	FR Citation
Final Rule	12/18/1992	57FR60430

**Topical Antifungal Drug Products: Indications**
Proposed Rule	Date	FR Citation
Proposed Rule: Revises "cures" to "cures most" and "treats" to "treats most"	7/22/1999	64FR39452
Final Rule	Date	FR Citation
Final Rule	8/29/2000	65FR52302

**Topical Antifungal Drug Products: Treatment of Tinea Pedis**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Notice: Advisory Committee meeting on effectiveness and labeling	3/30/2004	69FR16582
Correction	4/22/2004	69FR21838

**Topical Antifungal Drug Products: Vaginal Drug Products**
Proposed Rule	Date	FR Citation
Reopening of Administrative Record	11/19/1997	62FR61710

Date created: December 28, 2006; Last updated: May 4, 2007