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  1. FDA User Fee Programs

Potential Over-the-Counter Monograph User Fees

A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. This website will be updated as further information on the development of a potential user fee program becomes available.

For questions relating to potential OTC monograph user fees, please email us at:
OTCMonographUserFeeProgram@fda.hhs.gov