Over-the-Counter Monograph Drug User Fee Amendments

This bill keeps the federal program that funds work on nonprescription (over‑the‑counter) medicines going for five more years and updates how companies are charged. It extends the program through 2030, sets when fees are due, and explains how yearly fee targets are calculated. The money is dedicated to activities for these drugs.

Companies that own facilities making these medicines will pay facility fees on a set schedule, with special timing in 2026 and 2027, and a regular fall due date starting in 2028. Firms that fully stop all related activities before certain cutoff dates won’t owe the fee for that year. The law also allows a one‑time fee increase later in the program if the number of facilities grows more than expected.

• Who is affected

  • Companies that own or run over‑the‑counter monograph drug facilities (they pay facility fees).
  • Sponsors, requestors, or organizations they nominate can get development advice from the agency.

• What changes

  • Program is extended; fee revenue is set each year using base amounts plus adjustments like inflation and specific add‑ons for 2026–2028, with a possible one‑time workload adjustment.
  • Annual reports are required within 120 days after each fiscal year.

• When

  • Most changes take effect October 1, 2025; fees start being assessed on that date.
  • The fee program ends October 1, 2030; related reporting ends January 31, 2031.
  • Prior‑year fees remain governed by the old rules (a savings clause).