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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The 31 March cut-off date brings to a comparatively low-profile end a well-chronicled saga of FDA acting to increase OTC hand sanitizer production as consumer demand soared in response to COVID-19.
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.