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 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC First Aid Antibiotic Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC First Aid Antibiotic Drug Products
  
  	
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    Print**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 CertificationTopical Antibiotic Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			4/1/1977
			42FR17642Correction
			4/29/1977
			42FR21816Reopening of Administrative Record
			3/21/1980
			45FR18400Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			7/9/1982
			47FR29986Correction
			1/9/1992
			57FR858Proposed Rule: Divides monograph into multiple subparts; proposes first aid antiseptic part
			7/22/1991
			56FR33644Final Rule
			Date
			*FR* CitationFinal Monograph
			12/11/1987
			52FR47312Technical Amendment
			5/25/1988
			53FR18837Final 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* CitationProposed Rule
			2/14/1996
			61FR5918Final Rule
			Date
			*FR* CitationFinal Rule
			11/15/1996
			61FR58471

Topical Antibiotic Drug Products: Bacitracin Combinations

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies bacitracin-polymyxin B sulfate aerosol with suitable anesthetic as GRASE combination
			8/18/1989
			54FR34188Proposed Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate
			5/11/1990
			55FR19868Proposed Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE
			6/8/1990
			55FR23450Correction
			6/21/1990
			55FR25392Final Rule
			Date
			*FR* CitationFinal Rule: Classifies bacitracin- polymyxin B sulfate aerosol as GRASE combination
			3/15/1990
			55FR9721Final Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate
			10/3/1990
			55FR40379Final 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* CitationProposed Rule: Exempts monograph products
			7/22/1985
			50FR29702Final Rule
			Date
			*FR* CitationFinal Rule
			7/15/1986
			51FR25523Correction
			8/27/1986
			51FR30478Correction
			9/24/1986
			51FR33897

                                                                                  Content current as of:
      03/02/2017Historical Status of OTC Rulemakings
 
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