Over-the-Counter Monograph Drug User Fee Amendments

This bill would reauthorize the Over-the-Counter Monograph Drug User Fee Program through fiscal year 2030, allowing the Food and Drug Administration to continue collecting fees from facilities that manufacture certain non-prescription drugs. The proposal would update the total revenue targets for these fees, adjust payment deadlines, and require the agency to publish fee amounts at least 60 days before each fiscal year begins. Additionally, the bill would establish a new category of requests for modifying drug testing procedures based on voluntary industry standards.

This bill affects facilities that manufacture over-the-counter (OTC) drugs marketed under the Food and Drug Administration (FDA) monograph system, as well as entities that submit requests to modify these monographs. The FDA is also affected, as the legislation reauthorizes and revises its authority to collect user fees and manage the monograph program through fiscal year 2030. Additionally, the bill impacts requestors seeking to add or modify drug testing procedures that reflect voluntary consensus standards for pharmaceutical quality.

• Reauthorization of the OTC Monograph Drug User Fee Program. The bill extends the authority for the Food and Drug Administration to collect fees from over-the-counter drug facilities and monograph change requesters through fiscal year 2030.
• Adjustment of facility fee revenue and schedules. The legislation revises the total facility fee revenue targets for fiscal years 2026 through 2030 and updates the due dates for these payments. It also grants the FDA authority to implement a one-time fee adjustment under specific conditions.
• Enhanced fee transparency requirements. The FDA is required to publish the specific amounts for facility fees and monograph order request fees at least 60 days before the beginning of each fiscal year.
• Expansion of Tier 2 monograph order requests. The bill classifies requests to add or modify drug testing procedures as Tier 2 requests, provided they reflect voluntary consensus standards for pharmaceutical quality. These specific requests are not eligible for market exclusivity.

The bill reauthorizes the user fee program through fiscal year 2030 and establishes revised facility fee revenue amounts and administrative requirements for fiscal years 2026 through 2030.

This bill reauthorizes and modifies the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) through fiscal year 2030. It amends existing program requirements regarding the collection of fees from drug facilities, the timing of fee publications, and the classification of monograph order requests.

The bill aims to reauthorize and modify the Over-the-Counter (OTC) Monograph Drug User Fee Program through fiscal year 2030. It updates the program's financial structure by revising fee collection amounts and deadlines, while also expanding the types of requests allowed for modifying drug testing procedures to include voluntary consensus standards.