Over-the-Counter Monograph Drug User Fee Amendments

The bill would reauthorize the FDA's Over-the-Counter (OTC) Monograph Drug User Fee Program through fiscal year 2030, which funds FDA oversight of nonprescription drugs marketed under FDA monographs rather than individual drug approvals. It would revise how facility fee revenue is calculated each year, change the due dates and payment schedule for facility fees (including a two-installment option in fiscal year 2027), and let the FDA impose a one-time fee increase in FY2028-FY2030 if the number of fee-paying facilities grows substantially and few fall into arrears. It would also add a new category of fee-eligible "Tier 2" request covering new or modified testing procedures based on voluntary consensus quality standards, and require the FDA to publish fee amounts at least 60 days before each fiscal year begins. It would not change the underlying framework for how OTC drugs qualify for marketing under a monograph, and existing fees for years before FY2026 would still be collected under prior law under a savings clause. The amendments would take effect October 1, 2025, or on enactment, whichever is later.

Facilities that manufacture or process over-the-counter monograph drugs and pay annual facility fees, companies or organizations that submit monograph order requests (including testing-procedure change requests), and the FDA, which administers the fee program and reports to Congress on its implementation.

Without reauthorization, the FDA could lose a funding stream and dedicated staff capacity for reviewing OTC drug monograph changes and facility compliance, potentially slowing agency work on drug safety and labeling updates. Facilities would face revised fee amounts, due dates, and a possible new one-time fee increase, affecting their compliance costs and timing.

The FDA would recalculate annual facility fee revenue targets each year using a formula combining a base amount, inflation adjustment, operating reserve adjustment, and fixed dollar add-ons, then publish the resulting facility and order-request fees in the Federal Register at least 60 days before each fiscal year. Facilities would pay fees on revised schedules, including installments in FY2027. The FDA could apply a one-time fee increase in FY2028-2030 only if facility counts and arrears rates meet specified thresholds, and must report annually to Congress on program implementation through FY2030.