On March 20, 2025, the US Food and Drug Administration (FDA) announced its 2025 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). These fees are required to be paid by all "qualifying persons who own an OTC monograph drug facility, including contract manufacturing organization facilities". This year, the [...]
On March 24, 2023, the US Food and Drug Administration (FDA) announced its 2023 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The Monograph Drug Facility (MDF) fee has increased by $1,975 from $24,178 last year and the Contract Manufacturing Organization (CMO) fee has increased by $1,316 from [...]
On March 26, 2021, the US Food and Drug Administration (FDA) announced its 2021 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). This fee assessment was authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act which added a new provision to the Federal Food, Drug and [...]