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