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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 Sweet Spirits of Nitre Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Sweet Spirits of Nitre Drug Products
  
  	
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    Print**Final Monograph** (21 CFR 310.502(a))**:***Certain drugs accorded new drug status through rulemaking procedures*

OTC Sweet Spirits of Nitre Drug Products found on this page:

Original Classification
	Consolidation of Drug Regulations**Sweet Spirits of Nitre Drug Products: Original Classification**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies sweet spirits of nitre as nonmonograph
			2/22/1980
			45FR11846Correction
			3/25/1980
			45FR19265Final Rule
			Date
			*FR* CitationFinal Rule
			6/27/1980
			45FR43400

**Sweet Spirits of Nitre Drug Products: Consolidation of Drug Regulations**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Removes 21 CFR 310.525 and adds 21 CFR 310.502
			6/11/1996
			61FR29502Final Rule
			Date
			*FR* CitationFinal Rule
			3/14/1997
			62FR12083

                                                                                  Content current as of:
      03/01/2022Historical Status of OTC Rulemakings
 
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