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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Topical Antifungal Drug Products
  1. Historical Status of OTC Rulemakings

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 47FR12480disclaimer icon
    Correction [PDF] 4/23/1982 47FR17575disclaimer icon
    Correction [PDF] 12/7/1982 47FR54981disclaimer icon
Proposed Rule Date FR Citation
Tentative Final Monograph 12/12/1989 54FR51136disclaimer icon
    Correction 1/9/1990 55FR797disclaimer icon
    Correction 1/22/1990 55FR2202disclaimer icon
Final Rule Date FR Citation
Final Rule: Nonmonograph labeling claims

9/2/1993

58FR46744disclaimer icon
Final Monograph 9/23/1993 58FR49890disclaimer icon

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 57FR38568disclaimer icon
    Correction 9/8/1992 57FR40944disclaimer icon
    Technical Amendment: Correct an ingredient name 10/1/1992 57FR45295disclaimer icon
    Correction 11/9/1992 57FR53300disclaimer icon
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as non-monograph 5/10/1993 58FR27636disclaimer icon

Topical Antifungal Drug Products: Clotrimazole

Proposed Rule Date FR Citation
Proposed Rule: Adds clotrimazole as GRASE active ingredient 5/29/2001 66FR29059disclaimer icon
Final Rule Date FR Citation
Final Rule 2/8/2002 67FR5942disclaimer icon

Topical Antifungal Drug Products: Diaper Rash

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 9/7/1982 47FR39464disclaimer icon
Extension of Comment Period 12/28/1982 47FR57738disclaimer icon
Proposed Rule Date FR Citation
Proposed Rule: Classifies diaper rash claim as nonmonograph 6/20/1989 55FR25240disclaimer icon
Correction 7/19/1990 55FR29453disclaimer icon
Final Rule Date FR Citation
Final Rule 12/18/1992 57FR60430disclaimer icon

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 64FR39452disclaimer icon
Final Rule Date FR Citation
Final Rule 8/29/2000 65FR52302disclaimer icon

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 69FR16582disclaimer icon
Correction 4/22/2004 69FR21838disclaimer icon

Topical Antifungal Drug Products: Vaginal Drug Products

Proposed Rule Date FR Citation
Reopening of Administrative Record 11/19/1997 62FR61710disclaimer icon

 

 
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