Changes to Antiseptic Regulations

FDA recently released a proposed amendment to the 1994 Tentative Final Monograph (TFM) for Healthcare Antiseptic Drug Products.  The proposed amendment is open for comment until October 28, 2015.

Key changes would include:

  • Alcohols and iodine go to “Category III”
  • Clinical and in vitro data now required for all actives
  • Log reduction of >2.5 within 5 minutes required
  • Minimum bactericidal concentration (MBC) may replace minimum inhibitory concentration (MIC) tests
  • New requirements for toxicity testing of actives

For the dozens of companies that make alcohol-based hand sanitizers, the proposed rule has a large potential impact.  As stated by FDA, Category III means “available data are insufficient to classify [an active ingredient] as safe and effective, and further testing is required.”  Thus, companies that have not been historically required to generate data supporting the efficacy of their products will be required to conduct testing. 

If FDA were to finalize the monograph and conclude that insufficient data exists to substantiate the safety or efficacy of alcohol as an active ingredient, then all alcohol-based hand sanitizers would require New Drug Applications.  FDA has relied upon the tentative final monograph for more than 20 years, so transition to a final monograph may take several more years.