Dow Isopropanol, HS grade, is an alternative material for compounders to use as an active ingredient in hand sanitizers. This material meets the final test result specifications listed in the USP monograph. FDA has reviewed Dow's manufacturing information and analytical results and considers this grade of IPA is acceptable for use under the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry (updated June 1, 2020) or section 505G of the FD&C Act.
For the most current information on the status of the temporary policy, 505G of the FD&C Act, and Rulemaking History for OTC Topical Antimicrobial Drug Products, visit the following links:
(updated June 1, 2020)
Rulemaking History for OTC Topical Antimicrobial Drug Products
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