Last week FDA announced the fiscal year 2021 OTC-Drug User Fee rates in a Federal Register Notice. Under the new 2021 rates:
- Owners of manufacturing and processing facilities of finished OTC-drug dosage forms will pay a full facility fee: $14,060.
- Owners of a contract manufacturing facility will pay 2/3 of the full fee: $9,373.
Payment is due to FDA within 45 days of the notice’s publication and these user fees apply to all qualifying manufacturers and processors of finished dosage form OTC monograph drugs, including contract manufacturing facilities and submitters of OTC monograph order requests.
Do you know if your Contract Manufacturing Organization is aware of their user fee obligation?
EAS Consulting Group assists clients with facility registrations, drug listings and coordination of User Fee payments in accordance with FDA requirements. We can also assist with notification of facility registration cancellations and the delisting products no longer in production.
Of note to firms engaged in manufacturing emergency use (CDC/WHO formulas) hand sanitizers under the DHHS/FDA’s COVID-19 Pandemic emergency guidance documents, rather than the OTC Monograph formulas: FDA considers these products OTC drugs and the facilities where they are made responsible for paying an OTC-Drug Monograph User Fee facility fee.
Still have questions? Contact Victoria Pankovich, EAS Regulatory Specialist.