Who is affected and how:

• Drug manufacturers and applicants: Directly affected as primary fee payers; they must budget for revised annual fees and comply with the updated assessment timeline. Changes to allowed testing procedures (recognizing voluntary consensus standards via FDA guidance) may reduce testing burden for some firms if adopted.

• Pharmacies and wholesalers / dispensers: May be assessed fees depending on the statutory fee categories and could face small increases in operating costs that may, over time, affect distribution or retail pricing dynamics.

• Consumers: Indirectly affected because fee-funded FDA activities fund rulemaking, review, and oversight of OTC monograph products; adequacy of funding can affect review speed, safety oversight, and availability of OTC products.

• FDA and HHS: Receive a dedicated revenue stream restricted to OTC monograph activities, enabling planning for program work but with clear limits on fund use, new reporting/timetable obligations, and responsibility to recognize specified consensus testing standards when appropriate.

• Small businesses and startups in the OTC market: May feel proportionally larger impact from fees; the Act does not appear to include explicit small-business fee waivers in the text summarized, so affected entities should plan accordingly.

• Timeline and administrative impact: The fixed annual fee publication timetable and updated crediting/availability rules create predictable requirements for agency rulemaking and industry compliance. Sunset dates mean the program is temporary unless extended by future legislation.

Overall effect: The law refines and extends fee-raising authority to resource FDA's OTC monograph work with clearer limits on fund use, updated technical recognition of testing standards, and new schedules and formulas for fees — while preserving prior rules for pre-2026 fees and setting explicit sunset dates for the new authority.