For certain “companies that first registered with the FDA during the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE were not identified as facilities subject to the OMUFA facility fee, for a certain time period. That time period, which extended beyond the end of the PHE, […]
In an announcement today, the FDA reminded manufacturers of alcohol-based hand sanitizers that they can no longer distribute products made under the temporary policy, which was withdrawn on December 31, 2021 and gave manufacturers until March 31, 2022 to comply (see the announcement here). The Agency notes that distribution from manufacturers to all outlets, which […]
In a prepublication Federal Register (FR) notice (here), the “Food and Drug Administration (FDA or Agency) is announcing the withdrawal of three guidance documents titled ‘Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),’ ‘Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health […]
Be careful out there, warns FDA, as they continue to see hand sanitizers containing potentially deadly methanol (as well as other toxic substances). The FDA has a DO NOT USE list of hand sanitizers (here) and issued another warning about assuring safe use of these products in a press release on July 27, 2020 (here). […]
FDA issued three updated guidance documents that have revised recommendations and additional information on the preparation, manufacture, and temporary compounding of hand sanitizers under the COVID-19 public health emergency. The Agency provides additional guidance on the use of both active and inactive ingredients, updates permitted formulation and denaturing processes, and discusses permissible levels of impurities […]
