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US OTC Monograph Drug Facility Fees Up 8%, Higher Price Tags Stuck On OMORs, Too

 
• By Malcolm Spicer

FY2023 OTC monograph user fee target facility fee revenue is $25.4m from manufacturers’ fees of $26,153 and contract manufacturers’ fees of $17,435, all due by 1 June. OMOR fees are $517,381 for Tier 1 requests and $103,476 for Tier 2.

• Source: Shutterstock

Total facility registration fees in the US OTC monograph user fee program are up for fiscal year 2023 as the fees each manufacturer will pay increase 8% from FY2022.

Also increasing for the current fiscal year are the price tags for the two types of OTC monograph order requests, the Food and

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