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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Topical Antifungal Drug Products

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:

 


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

9/2/1993

 58FR46744
Final Monograph [PDF] 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 [PDF] 8/25/1992 57FR38568
    Correction [PDF] 9/8/1992 57FR40944
    Technical Amendment: Correct an ingredient name [PDF] 10/1/1992 57FR45295
    Correction [PDF] 11/9/1992 57FR53300
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as non-monograph [PDF] 5/10/1993 58FR27636

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

Topical Antifungal Drug Products: Diaper Rash
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 9/7/1982 47FR39464
     Extension of Comment Period [PDF] 12/28/1982 47FR57738
Proposed Rule Date FR Citation
Proposed Rule: Classifies diaper rash claim as nonmonograph [PDF] 6/20/1989 55FR25240
    Correction [PDF] 7/19/1990 55FR29453
Final Rule Date FR Citation
Final Rule [PDF] 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" [PDF] 7/22/1999 64FR39452
Final Rule Date FR Citation
Final Rule [PDF] 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 [PDF] 3/30/2004 69FR16582
    Correction [PDF] 4/22/2004 69FR21838

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