Office of Nonprescription Products
Over-the-Counter (OTC) Related Federal Register Notices, Ingredient References,
and other Regulatory Information

OTC-Related Federal Register Publications

• Rulemaking History for OTC Drug Products. Index of Full-text Federal Register publications organized by OTC drug product category.
• FDA Regulations Open for Comment
• Annual Comprehensive List of Guidance Documents at the Food and Drug Administration [TXT] [PDF] (Issued 1/5/2005)
• Summary of Sunscreen Rulemakings
  

Index of Significant OTC Drug Federal Register Publications

• 2000 to 2008 (Updated 8/14/2008)
• 1990 to 2003
• 1980-1989
• 1972-1981
  

Status of OTC Rulemakings

• Unified Agenda Rulemakings under review/development.
• Drug Facts Labeling Information
• Sample Drug Facts Labels
  

OTC Active Ingredient and Drug Product References

• Listing of OTC Active Ingredients
  
  • Alphabetical Listing
  • By Monograph/Category
    
• Approved Drug Products (Orange Book)
• National Drug Code (NDC) Directory
• New & Generic Drug Approval Packages
• Inactive Ingredient Search for Approved Drug Products
• Rx-to-OTC Switch List (Updated 10/20/2008)
  

Other Regulatory Information

• Clarification of Recent FDA Initiatives Affecting OTC Drugs
• How FDA Regulates OTC Drugs
• Frequently Asked Questions on the Regulatory Process of OTC Drugs
• Consumer Healthcare Products Association (CHPA) / FDA Joint Seminar Series
• Guidelines for Effectiveness Testing of OTC Antiperspirant Drug Products
• Nonprescription Drugs Advisory Committee (NDAC) Meetings
• Chronological List of All NDAC Meetings (1992 to Present)
• How to Comment on Proposed Regulations and Submit Petitions
• "Is it Cosmetic, a Drug, or Both?  (Or is it a Soap?)"
• Laws Enforced by FDA
• Regulatory and Scientific Guidances
• Import Regulations and Procedures
• Drug Registration and Listing Requirements
• Small Business Assistance
• Regulations.gov. This U.S. Government web site makes it easier for you to participate in Federal rulemaking - an essential part of the American democratic process.

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Date updated: March 4, 2009

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