Industry Information: 
OTC-Related Federal Register Notices,
Ingredient References, and other Regulatory Information

• OTC-related Federal Register publications
  • FDA Regulations Open for Comment
  • Rulemaking History for OTC Drug Products. (10/15/2004) Index of Full-text Federal Register publications organized by OTC drug product category.
  • Rulemaking History for Time and Extent Applications
  • Administrative Procedure Rulemakings
  • General Labeling Rulemakings
    
    
• Index of Significant OTC Drug Federal Register publications
  • 1990 to 2003   (7/11/2003)
  • 1980-1989
  • 1972-1981
    
    
• Status of OTC rulemakings
  • The Milestone List 6/13/2003   (Posted 7/11/2003)  List of the Federal Register publication dates of all major OTC rulemakings
  • OTC Unified Agenda   (7/12/2004)  Rulemakings under review/development.
  • Drug Facts Labeling Information 
    
    
• OTC drug product and ingredient references
  • OTC Drug Review Ingredient Status Report, July 2003. (Posted 7/30/2003).   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.
    • Ingredients A-C
    • Ingredients D-O
    • Ingredients P-Z
  • Approved Drug Products (Orange Book)
  • National Drug Code (NDC) Directory
  • New & Generic Drug Approval Packages
    
    
• Other Regulatory Information
  • "Over the Counter and On the Air: The Advertising of OTC Drug Products," FDA-CHPA Seminar, May 13, 2004. [HTML] or [PowerPoint]  (6/8/2004)

  • Frequently Asked Questions on the Regulatory Process of OTC Drugs (4/5/2004)

  • Guidelines for Effectiveness Testing of OTC Antiperspirant Drug Products. [WORD] [PDF]
  • Nonprescription Drugs Advisory Committee (NDAC) Meetings
  • How to Comment on Proposed Regulations and Submit Petitions
  • FDA-CHPA Seminar, October 2, 2003, "Working Within the OTC Drug Monographs"  (Posted 10/3/2003)
  • "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.