‘OMUFA Fee Liable’ Trending In US OTC Drug Industry To Pay For FDA's Monograph Reform

Some firms with sales in nonprescription drug space are exempt from program’s facility fees, but own-label OTC drug marketers aren’t among them. Although FDA allows fee discounts for small businesses in other areas, it’s not trimming monograph user fee rates.

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

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