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FDA Issues New Guidance On Pharmaceutical Alcohol

Agency has concerns about methanol contamination in drug products other than hand sanitizer.

To help protect consumers from methanol poisoning, the FDA has issued a new guidance,“Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19),” to notify drug manufacturers and compounders of FDA’s policy on certain testing procedures on all lots of alcohol and isopropyl alcohol prior to manufacturing to prevent methanol contamination or substitution in drugs.     This guidance is intended to alert pharmaceutical manuf...

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