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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FDA publishes second notice on FY2021 rates for OTC monograph drug user fee program. With fewer firms paying, those still subject to facility fees will pay more so the total collected matches amount Congress authorized agency to collect, nearly $23.3m.
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.”