Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027
FDA sets FY2027 user fee rates for OTC monograph drugs; fees apply to certain submissions and facilities.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 29, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) facilities that engage with OTC monograph drugs. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Fiscal year 2027 begins October 1, 2026; fees are effective for that fiscal year.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
User fee rates for OTC monograph drug activities for fiscal year 2027 are established.
Who it affects
Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) facilities that engage with OTC monograph drugs.
What you must do
Review the new fee schedule and budget for any applicable fees; ensure timely payment for submissions or facility fees.
Deadline
Fiscal year 2027 begins October 1, 2026; fees are effective for that fiscal year.
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