FDA Withdrawal of Temporary Guidances for Alcohol-Based Hand Sanitizers

by | Oct 26, 2021 | OTC Drugs, Research/Science/Technology, U.S. Regulatory

Did your company manufacture alcohol-based hand sanitizer or manufacture alcohol for use in hand sanitizers during the COVID-19 pandemic based on temporary policies outlined in FDA guidances originally issued in March 2020? If so, it is important for your company to note that, effective Dec. 31, 2021, these guidances are to be withdrawn. If this affects your company, the following is what you need to know:

  • Effective Dec. 31, 2021, you must cease all production of alcohol-based hand sanitizers.
  • If you cease production of alcohol-based hand sanitizers, you must deregister.
  • The deadline to sell any alcohol-based hand sanitizer produced on or before Dec. 31, 2021 is Mar. 31, 2022.
  • If you wish to continue production, you may do so provided you comply with the OTC topical antiseptics tentative final monograph and other requirements, including FDA cGMP.

If you would like further information on this, please do not hesitate to contact us.