Rulemaking History for OTC First Aid Antibiotic Drug Products

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Rulemaking History for OTC First Aid Antibiotic Antibiotic Drug Products
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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:

Original Active Ingredients and Labeling
Allergy Warning
Bacitracin Combinations
Exemption from Batch Certification

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**Topical Antibiotic Drug Products: Original Active Ingredients and Labeling**
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 Citation
Tentative 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 Citation
Final 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

**Topical Antibiotic Drug Products: Allergy Warning**
Proposed Rule	Date	FR Citation
Proposed Rule	2/14/1996	61FR5918
Final Rule	Date	FR Citation
Final Rule	11/15/1996	61FR58471

**Topical Antibiotic Drug Products: Bacitracin Combinations**
Proposed Rule	Date	FR Citation
Proposed 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 Citation
Final 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

**Topical Antibiotic Drug Products: Exemption from Batch Certification**
Proposed Rule	Date	FR Citation
Proposed Rule: Exempts monograph products	7/22/1985	50FR29702
Final Rule	Date	FR Citation
Final Rule	7/15/1986	51FR25523
Correction	8/27/1986	51FR30478
Correction	9/24/1986	51FR33897

Date created: December 28, 2006; Last updated: May 9, 2007