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  6. Status of OTC Rulemakings
  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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 5/21/1982 47FR22324

Topical Antimicrobial Drug Products: Diaper Rash

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 9/7/1982 47FR39406
    Correction 12/7/1982 47FR54981
    Extension of Comment Period 12/28/1982 47FR57738
Proposed Rule Date FR Citation
Proposed Rule 6/20/1990 55FR25246

Topical Antimicrobial Drug Products: First Aid Antiseptic

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 9/13/1974 39FR33103
    Extension of Comment Period  10/17/1974 39FR37066
Proposed Rule Date FR 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: Category II & III active ingredients 10/26/1979 44FR61609
Reopening of Administrative Record 3/21/1980 45FR18398
Proposed Rule: Establishes first aid separate from healthcare antiseptics 7/22/1991 56FR33644
    Correction 1/9/1992 57FR858
Call for Data: Miscellaneous products 12/31/2003 68FR75585

Topical Antimicrobial Drug Products: Healthcare Antiseptic

Advance Notice of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 9/13/1974 39FR33103
    Extension of Comment Period 10/17/1974 39FR37066
Proposed Rule Date FR 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
Notice: Public Hearing and Request for Comment 11/21/2012 77FR69863
Proposed Rule: Establishes GRAS/E conditions for healthcare antiseptics  5/1/2015   80FR25166 
Final Rule: Finalizes rulemaking for healthcare antiseptics 12/20/2017   FR  12/20/2017

Topical Antimicrobial Drug Products: Consumer Antiseptic

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 9/13/1974 39FR33103
Extension of Comment Period 10/17/1974 39FR37066
Proposed Rule Date FR 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); Final Monograph 9/06/2016 81FR61106

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

4/12/2019

84FR14847

Topical Antimicrobial Drug Products: Nonmonograph Ingredients

Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph 8/25/1992 57FR38568
    Correction 9/8/1992 57FR40944
    Technical Amendment: Correct an ingredient name 10/1/1992 57FR45295
    Correction 11/9/1992 57FR53300
Proposed Rule: 60+ Drug Categories 6/19/2008 73FR34895
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph 4/22/1998 63FR19799

Topical Antimicrobial Drug Products: Hexachlorophene

Proposed Rule Date FR Citation
Proposed Rule 1/7/1972 37FR219
    Request for Data: Hexachlorophene + 7 other ingredients 1/7/1972 37FR235
    Correction:1/7/1972 Request for Data 1/26/1972  37FR1182
Final Rule Date FR Citation
Final Rule 9/27/1972 37FR20160
    Technical Amendment: Aerosol content determination 11/4/1972 37FR23537

Topical Antimicrobial Drug Products: Tribromsalan

Proposed Rule Date FR Citation
Proposed Rule:  Prohibits certain halogenated salicylanilides 9/13/1974 39FR33102
Final Rule Date FR Citation
Final Rule 10/30/1975 40FR50527

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