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FDA Regulation of Hand Sanitizers: What Testing Should be Conducted to Market a New Hand Sanitizer?

Published Date: May 12, 2022

All hand sanitizers, whether used by consumers or healthcare professionals, are considered over-the-counter (OTC) drugs that are regulated by the FDA. As with any new human-use product entering the market, the FDA requires Good Manufacturing Practices, safety data, and in vitro and in vivo efficacy data before the product is marketed to the public. This presentation discusses the required in vitro and clinical safety & efficacy testing to conduct and important considerations for study design.

Key areas of discussion:

  • FDA monograph and current requirements
  • Requirements for safety testing
  • Applicable screening tests and basic methodologies
  • Overview of clinical evaluations for hand sanitizers

Learn more about the presenter below.


Russell Griggs

Principle Investigator II

Russell Griggs earned his B.A. from Middlebury College (Middlebury, VT) in 2010 with a major in molecular biology and biochemistry. He earned an M.S. in earth sciences from Montana State University (Bozeman, MT) in 2013 with a focus on low-temperature geochemistry and subglacial microbial processes. Russell has worked for Nelson Labs for 8 years with a focus on conducting clinical and in vitro testing of topical antiseptics.

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