Drugs

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 [PDF] 5/21/1982 47FR22324

Topical Antimicrobial Drug Products: Diaper Rash

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

Topical Antimicrobial Drug Products: First Aid Antiseptic

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

Topical Antimicrobial Drug Products: Healthcare Antiseptic

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

Topical Antimicrobial Drug Products: Consumer Antiseptic

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 9/13/1974 39FR33103
Extension of Comment Period [PDF] 10/17/1974 39FR37066
Proposed Rule Date FR 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

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

6/29/2016

Topical Antimicrobial Drug Products: Nonmonograph Ingredients

Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [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
Proposed Rule: 60+ Drug Categories [PDF] 6/19/2008 73FR34895
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 4/22/1998 63FR19799

Topical Antimicrobial Drug Products: Hexachlorophene

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

Topical Antimicrobial Drug Products: Tribromsalan

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

 

 

Page Last Updated: 06/29/2016
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