US FDA announces withdrawal of 3 temporary guidance documents established during COVID-19 for alcohol-based products

November 15, 2021

The US Food & Drug Administration (FDA) recently issued a notice in the federal register (Docket No. FDA–2020–D–1106) announcing the withdrawal of three guidance documents applicable to alcohol-based hand sanitizers previously issued in the wake of the COVID-19 pandemic.

Guidance withdrawal

The three guidance documents being revoked are:

  1. Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
  2. Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
  3. Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

Based on consumer data, the FDA has determined that there are no longer supply chain constraints preventing production of, or access to, alcohol-based hand sanitizers or alcohol produced for such products. The temporary guidance documents, which were enacted to ease constraints due to an influx in demand for alcohol-based hand sanitizers, are therefore no longer necessary according to the FDA.

Important dates

Manufacturers must cease production of alcohol-based hand sanitizers produced under the temporary guidance documents by December 31, 2021. Sellers must cease distribution of products produced under the guidance documents no later than March 31, 2022.

How can TSG help?

TSG’s experts are equipped to ensure your company is compliant under the changes to FDA regulation. Have a question? Get in touch: info@tsgconuslting.com

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