FDA announced the fiscal year 2021 OTC-Drug User Fee rates in a Federal Register Notice published today, 12/29/2020. The notice covers all qualifying manufacturers and processors of finished dosage form OTC monograph drugs, including contract manufacturing facilities and submitters of OTC monograph order requests. Those affected by the OTC-Drug Monograph User Fee Program (OMUFA) must ensure proper registration with FDA and payment of the appropriate user fee within 45 days of this publication.
Regarding fee specifics,
- 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: $9373.
- Submitters of OTC monograph order requests (OMOR) will pay tier-based user fees, (with the exception of those submitting certain safety-related changes). Tier 1 OMOR user fees are assessed at $500,000, Tier 2 OMOR user fees are assessed at $100,000.
Those firms that are 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, should be aware that FDA considers these products OTC drugs and the facilities where they are made responsible for paying an OMUFA facility fee.
Only those facilities that ceased OTC monograph drug activities, and updated their registration with FDA to that effect, prior to December 31, 2019 (see section 744M(a)(1)(B)(i) of the FD&C Act) are exempt.
These fees are effective as of October 1, 2020, and will remain in effect through September 30, 2021.
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.
Still have questions? Contact Victoria Pankovich, EAS Regulatory Specialist.
Posted in Client Update.