Over-the-Counter Monograph Drug User Fee Amendments

This legislation, known as the Over-the-Counter Monograph Drug User Fee Amendments, aims to reauthorize and significantly revise the user fee program for over-the-counter (OTC) monograph drugs. The program is extended for an additional five fiscal years, covering fiscal years 2026 through 2030 , ensuring continued funding for the Food and Drug Administration's (FDA) oversight of these products. Congress explicitly finds that the authorized fees will be dedicated to OTC monograph drug activities. Key changes include modifications to the assessment and collection of facility fees . The bill alters the applicable periods for fee assessment and revises due dates, introducing a two-installment payment system for fiscal year 2027. It also updates the methodology for calculating fee revenue amounts, incorporating adjustments for inflation, operating reserves, and additional direct costs, alongside specific dollar amounts for certain fiscal years. A notable addition is a one-time facility fee workload adjustment that the Secretary may apply for fiscal years 2028, 2029, or 2030 under specific conditions related to facility numbers and arrears rates. Furthermore, the bill amends the definition of an OTC monograph drug to include the addition or modification of testing procedures that reflect voluntary consensus standards recognized by the Secretary. It also clarifies that the FDA can provide development advice to sponsors, requestors, or organizations nominated by them regarding nonprescription drugs. The authorization for these fee provisions will cease on October 1, 2030 , with reporting requirements ending on January 31, 2031.