US FDA Clarifies Testing In Sanitizer Production Temporary Guidances To Tighten Compliance
The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.
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FDA makes withdrawal effective on 31 December, also the deadline for firms manufacturing or compounding alcohol-based hand sanitizer products, and making alcohol for those products under temporary guidances, to cease production.
"Fewer people are manufacturing the products ... That seems to be a sort of a natural reaction to I think the decreased consumer demand," says Donald Ashley, compliance chief in FDA’s drug center.
Widespread problems FDA found in hand sanitizers resulted from businesses unfamiliar with drug production entering the space after agency eased manufacturing standards to encourage increased supplies. Heartburn remedy ranitidine noted due to its chemical profile, not errors by manufacturers.