US OTC Monograph Facilty Fees Increase With Pandemic-Inspired Sanitizer Makers Exempted
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.
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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.
The FDA says the new OTC monograph drug user-fee program (OMUFA) will provide additional resources needed to support the streamlined regulatory activities described by OTC drug reform legislation enacted in March 2020.
More than 6.2m containers of sanitizers have been recalled since mid-October due to methanol contamination. Total includes 67,440 made by Genesis Partnership Co., the first manufacturer in Guatemala that the FDA identified as making contaminated hand sanitizers distributed in the US.