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  7. Rulemaking History for OTC Topical Antimicrobial Drug Products
  1. Status of OTC Rulemakings

Rulemaking History for OTC Topical Antimicrobial Drug Products

Final Monograph (21 CFR part 333):
Topical Antimicrobial Drug Products for Over-the-Counter Human Use

OTC Topical Antimicrobial Drug Products found on this page:

Topical Antimicrobial Drug Products: Alcohol Original Indications

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking5/21/198247FR22324

Topical Antimicrobial Drug Products: Diaper Rash

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking9/7/198247FR39406
    Correction12/7/198247FR54981
    Extension of Comment Period12/28/198247FR57738
Proposed RuleDateFR Citation
Proposed Rule6/20/199055FR25246

Topical Antimicrobial Drug Products: First Aid Antiseptic

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking9/13/197439FR33103
    Extension of Comment Period 10/17/197439FR37066
Proposed RuleDateFR Citation
Tentative Final Monograph1/6/197843FR1210
    Extension of Comment Period2/3/197843FR4637
    Reopening of Administrative Record3/9/197944FR13041
    Reopening of Administrative Record: Category II & III active ingredients10/26/197944FR61609
Reopening of Administrative Record3/21/198045FR18398
Proposed Rule: Establishes first aid separate from healthcare antiseptics7/22/199156FR33644
    Correction1/9/199257FR858
Call for Data: Miscellaneous products12/31/200368FR75585

Topical Antimicrobial Drug Products: Healthcare Antiseptic

Advance Notice of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking9/13/197439FR33103
    Extension of Comment Period10/17/197439FR37066
Proposed RuleDateFR Citation
Tentative Final Monograph1/6/197843FR1210
    Extension of Comment Period2/3/197843FR4637
    Reopening of Administrative Record3/9/197944FR13041
    Reopening of Administrative Record10/26/197944FR61609
Proposed Rule: Establishes healthcare separate from first aid antiseptics6/17/1994

59FR31402

    Extension of Comment Period11/15/199459FR58799
    Reopening of Administrative Record5/29/200368FR32003
Call for Data: Miscellaneous products12/31/200368FR75585
Notice: Public Hearing and Request for Comment11/21/201277FR69863
Proposed Rule: Establishes GRAS/E conditions for healthcare antiseptics 5/1/2015  80FR25166 
Final Rule: Finalizes rulemaking for healthcare antiseptics12/20/2017  FR  12/20/2017

Topical Antimicrobial Drug Products: Consumer Antiseptic

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking9/13/197439FR33103
Extension of Comment Period10/17/197439FR37066
Proposed RuleDateFR Citation

Tentative Final Monograph

1/6/1978

43FR1210

Extension of Comment Period

2/3/1978

43FR4637

Reopening of Administrative Record

3/9/1979

44FR13041

Reopening of Administrative Record

10/26/1979

44FR61609

Proposed Rule: Establishes healthcare separate from first aid antiseptics

6/17/1994

59FR31402

Extension of Comment Period

11/15/1994

59FR58799

Reopening of Administrative Record

5/29/2003

68FR32003

Call for Data: Miscellaneous products

12/31/2003

68FR75585

Proposed Rule:  Establishes consumer antiseptic washes separate from healthcare antiseptics

12/17/2013

78FR76444

Proposed Rule: Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use (Consumer Antiseptic Rubs); Tentative Final Monograph

6/29/2016

81FR42911

Final Rule: Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use (Consumer Antiseptic Washes); Tentative Final Monograph

9/02/2016

81FR61106

Topical Antimicrobial Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph8/25/199257FR38568
    Correction9/8/199257FR40944
    Technical Amendment: Correct an ingredient name10/1/199257FR45295
    Correction11/9/199257FR53300
Proposed Rule: 60+ Drug Categories6/19/200873FR34895
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph4/22/199863FR19799

Topical Antimicrobial Drug Products: Hexachlorophene

Proposed RuleDateFR Citation
Proposed Rule1/7/197237FR219
    Request for Data: Hexachlorophene + 7 other ingredients1/7/197237FR235
    Correction:1/7/1972 Request for Data1/26/1972 37FR1182
Final RuleDateFR Citation
Final Rule9/27/197237FR20160
    Technical Amendment: Aerosol content determination11/4/197237FR23537

Topical Antimicrobial Drug Products: Tribromsalan

Proposed RuleDateFR Citation
Proposed Rule:  Prohibits certain halogenated salicylanilides9/13/197439FR33102
Final RuleDateFR Citation
Final Rule10/30/197540FR50527

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