Failing to pay an OTC drug monograph program user fee could have the US government knocking on a firm’s door, Food and Drug Administration officials advise while prepping the industry to add “OMUFA fee liable” to its commonly used terms.
While some firms with sales in the nonprescription drug space are exempt from the program’s facility fees, own-label OTC drug marketers aren’t among them—they’re OMUFA fee liable
Officials from the Division of User Fee Management in the FDA’s Center for Drug Evaluation and Research during a webinar on 3 June explained fee amounts and due dates and which businesses are subject to the fees the agency began collecting under OTC monograph drug program