Dear ACSA Members,
As of Monday December 7th, 2020, the US Department of Transportation Pipeline and Hazardous Materials Safety Administration (DOT-PHMSA) granted an extension of enforcement discretion for the transport of hand sanitizer mainly to help those who wish to deplete stock. More specifically, PHMSA gives notice that it will not take enforcement action against any offeror or carrier who offers or transports hand sanitizers manufactured and packaged prior to October 31, 2020, and in accordance with the April 10, 2020 “Temporary Policy for the Transportation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)” and the June 24, 2020 notice which extended the relief until October 31, 2020, and expanded it to include transportation by rail.
Please note; the current Notice provides relief to shippers offering stock that was packaged in accordance with the original notices PRIOR to October 31. PHMSA is NOT extending the original notice to anyone wishing to continue to manufacture and package the sanitizer, but only those who have stock manufactured and packaged prior to October 31, 2020. All hand sanitizers manufactured and packaged after October 31, 2020 must be in compliance with the HMR.
Per the text of the FDA temporary policy, authorization for manufacture of the WHO formula would last for the duration of the public health emergency, including any renewals. If you are planning to continue producing sanitizer, ACSA recommends that your distillery initiate a New Drug Application through the normal FDA registration process for OTC drugs.
