No ‘Surprise’ Facility Fees For Sanitizer Makers After Responding To COVID-19 Emergency In US
HHS says FDA made subject to monograph program facility fees businesses that began making hand sanitizers in response to temporary guidance easing manufacturing standards "about the same time” the department withdrew the user fee schedule.
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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.
The agency’s latest in a series of increasingly strident announcements expands its its warning not to use any hand sanitizers from the firms linked to methanol contamination “even if the product or particular lot number are not listed since some manufacturers are recalling only certain – but not all – of their hand sanitizer products.”
Dow Chemical, Anheuser-Busch and Kodak designate manufacturing for hand sanitizers and donate products to fight COVID-19. Dow is making up to 15 tons of sanitizer a day while Kodak donates formulas to New York's “NYS Clean” sanitizer distribution program.