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 Drug Product and Ingredient References

OTC Drug Review Ingredient Status Report, August 2006. (Posted 8/3/2006.)  This report contains an alphabetical listing of the ingredients considered in the OTC Drug Review that were classified and published in various Federal Register publications. This list includes over 2,700 ingredients (records) that provide a classification history throughout the rulemaking process.

• Guide: OTC Drug Review Ingredient Report This guide describes the information presented in the Report. (Posted 8/3/2006)
  • Ingredients A-C
  • Ingredients D-O
  • Ingredients P-Z
    
    
• 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: August 14, 2008

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