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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 Rulemaking [PDF]5/21/198247FR22324

Topical Antimicrobial Drug Products: Diaper Rash

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]9/7/198247FR39406
    Correction [PDF]12/7/198247FR54981
    Extension of Comment Period [PDF]12/28/198247FR57738
Proposed RuleDateFR Citation
Proposed Rule [PDF]6/20/199055FR25246

Topical Antimicrobial Drug Products: First Aid Antiseptic
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]9/13/197439FR33103
    Extension of Comment Period [PDF]10/17/197439FR37066
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]1/6/197843FR1210
    Extension of Comment Period [PDF]2/3/197843FR4637
    Reopening of Administrative Record [PDF]3/9/197944FR13041
    Reopening of Administrative Record: Category II & III active ingredients [PDF]10/26/197944FR61609
Reopening of Administrative Record [PDF]3/21/198045FR18398
Proposed Rule: Establishes first aid separate from healthcare antiseptics [PDF]7/22/199156FR33644
    Correction [PDF]1/9/199257FR858
Call for Data: Miscellaneous products [PDF]12/31/200368FR75585

Topical Antimicrobial Drug Products: Healthcare Antiseptic
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]9/13/197439FR33103
    Extension of Comment Period [PDF]10/17/197439FR37066
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]1/6/197843FR1210
    Extension of Comment Period [PDF]2/3/197843FR4637
    Reopening of Administrative Record [PDF]3/9/197944FR13041
    Reopening of Administrative Record [PDF]10/26/197944FR61609
Proposed Rule: Establishes healthcare separate from first aid antiseptics [PDF]6/17/199459FR31402
    Extension of Comment Period [PDF]11/15/199459FR58799
    Reopening of Administrative Record [PDF]5/29/200368FR32003
Call for Data: Miscellaneous products [PDF]12/31/200368FR75585
Notice: Public Hearing and Request for Comment11/21/201277FR69863

Topical Antimicrobial Drug Products: Consumer Antiseptic

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]9/13/197439FR33103
Extension of Comment Period [PDF]10/17/197439FR37066
Proposed RuleDateFR Citation

Tentative Final Monograph [PDF]

1/6/1978

43FR1210

Extension of Comment Period [PDF]

2/3/1978

43FR4637

Reopening of Administrative Record [PDF]

3/9/1979

44FR13041

Reopening of Administrative Record [PDF]

10/26/1979

44FR61609

Proposed Rule: Establishes healthcare separate from first aid antiseptics [PDF]

6/17/1994

59FR31402

Extension of Comment Period [PDF]

11/15/1994

59FR58799

Reopening of Administrative Record [PDF]

5/29/2003

68FR32003

Call for Data: Miscellaneous products [PDF]

12/31/2003

68FR75585

Proposed Rule:  Establishes consumer antiseptic washes separate from healthcare antiseptics

12/17/2013

78FR76444


Topical Antimicrobial Drug Products: Nonmonograph Ingredients
Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]8/25/199257FR38568
    Correction [PDF]9/8/199257FR40944
    Technical Amendment: Correct an ingredient name [PDF]10/1/199257FR45295
    Correction [PDF]11/9/199257FR53300
Proposed Rule: 60+ Drug Categories [PDF]6/19/200873FR34895
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]4/22/199863FR19799

Topical Antimicrobial Drug Products: Hexachlorophene
Proposed RuleDateFR Citation
Proposed Rule [PDF]1/7/197237FR219
    Request for Data: Hexachlorophene + 7 other ingredients [PDF]1/7/197237FR235
    Correction:1/7/1972 Request for Data [PDF]1/26/197237FR1182
Final RuleDateFR Citation
Final Rule [PDF]9/27/197237FR20160
    Technical Amendment: Aerosol content determination [PDF]11/4/197237FR23537

Topical Antimicrobial Drug Products: Tribromsalan
Proposed RuleDateFR Citation
Proposed Rule:  Prohibits certain halogenated salicylanilides [PDF]9/13/197439FR33102
Final RuleDateFR Citation
Final Rule [PDF]10/30/197540FR50527