Businesses that began making hand sanitizers in response to the COVID-19 pandemic won’t pay US OTC drug monograph program facility fees but firms subject to the requirement will pay $6,000 more than initially was calculated.
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.

More from Regulation
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.
Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.
Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.
More from Policy & Regulation
A round-up of the latest industry moves in Europe: Pharma Deutschland elects board of new Brussels operation; MHRA's new CEO gets to work; Futura names non-executive director.
“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. “If we reauthorize it, will it continue?” Texas representative Lizzie Fletcher asks of OMUFA.