FDA Logo links to FDA home page
U.S. Food and Drug Administration
  HHS Logo links to Department of Health and Human Services website
 MedWatch logoThe FDA Safety Information and Adverse Event Reporting Program

line line line line line

Reporting of Serious Adverse Events Associated with OTC Human Drug Products and Dietary Supplements

Public Law 109-462, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, was signed by President George Bush on December 22, 2006. Public Law 109-462 amends the Federal Food, Drug, and Cosmetic Act (the Act) to add safety reporting requirements for OTC drug products that are marketed without an approved application under section 505 of the Act (21 U.S.C. 355): http://www.fda.gov/cder/regulatory/public_law_109462.pdf. These reporting requirements become effective December 22, 2007.

Nonprescription Drug Products

  • Guidance to Industry for reporting post-marketing serious adverse events associated with nonprescription (over-the-counter (OTC)) human drug products marketed without an approved application. This document provides guidance on:
    • the minimum data elements that should be included in a serious adverse event report using MedWatch Form 3500A
    • the label that should be included with the report
    • reporting formats for paper and electronic submissions, and
    • how and where to submit the reports.
  • Additional information on adverse event reporting requirements which apply to the manufacturers, packers, and distributors of over-the-counter (OTC) or behind-the-counter (BTC) products

Dietary Supplements


horizonal rule