Final Monograph (21 CFR part 333 subpart A ): Topical Antimicrobial Drug Products for Over-the-Counter Human Use: First Aid Antibiotic Drug Products
OTC Topical Antibiotic Drug Products found on this page:
Advance Notice Of Proposed Rulemaking
Date
FR Citation Advance Notice of Proposed Rulemaking
4/1/1977
42FR17642 Correction
4/29/1977
42FR21816 Reopening of Administrative Record
3/21/1980
45FR18400 Proposed Rule
Date
FR CitationTentative Final Monograph
7/9/1982
47FR29986 Correction
1/9/1992
57FR858 Proposed Rule: Divides monograph into multiple subparts; proposes first aid antiseptic part
7/22/1991
56FR33644 Final Rule
Date
FR CitationFinal Monograph
12/11/1987
52FR47312 Technical Amendment
5/25/1988
53FR18837 Final Rule: Classifies category II and III ingredients without data as nonmonograph
4/22/1998
63FR19799
Proposed Rule
Date
FR CitationProposed Rule
2/14/1996
61FR5918 Final Rule
Date
FR CitationFinal Rule
11/15/1996
61FR58471
Proposed Rule
Date
FR CitationProposed Rule: Classifies bacitracin-polymyxin B sulfate aerosol with suitable anesthetic as GRASE combination
8/18/1989
54FR34188 Proposed Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate
5/11/1990
55FR19868 Proposed Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE
6/8/1990
55FR23450 Correction
6/21/1990
55FR25392 Final Rule
Date
FR CitationFinal Rule: Classifies bacitracin- polymyxin B sulfate aerosol as GRASE combination
3/15/1990
55FR9721 Final Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate
10/3/1990
55FR40379 Final Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE
12/5/1990
55FR50171
Proposed Rule
Date
FR CitationProposed Rule: Exempts monograph products
7/22/1985
50FR29702 Final Rule
Date
FR CitationFinal Rule
7/15/1986
51FR25523 Correction
8/27/1986
51FR30478 Correction
9/24/1986
51FR33897
Content current as of:
03/02/2017
