Methanol Content and How to Test for it: FDA Guidance : vima

Methanol Content and How to Test for it: FDA Guidance


Methanol Content and How to Test for it: FDA Guidance
January 22, 2021
Contact Author Rachel Grabenhofer
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Since relaxing the rules last March to quickly fulfill a desperate hand sanitizer need, the U.S. Food and Drug Administration (FDA) has been watching products flood the market—and flagging those tested or suspected to contain dangerous methanol in its "do not use" list.
Now, the agency has released a guidance policy for manufacturers to test for this contaminant in alcohol (ethanol) and ispropyl alcohol supplies before they are used for hand sanitizer production.
According to the policy:
"In response to the demand for alcohol-based hand sanitizers during the COVID-19 public health emergency, FDA issued temporary policies for the manufacture of alcohol-based hand sanitizer products and ethanol for use in alcohol-based hand sanitizer. The temporary policies explain that FDA does not intend to take action against firms with respect to certain violations of the FD&C Act, including section 501(a)(2)(B), provided that certain conditions are present.

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