Outsourcing Facility Fee Rates for Fiscal Year 2027
FDA announces FY 2027 fee rates for outsourcing facilities that compound human drugs: establishment fee $18,714, reinspection fee $4,679.
Aforeworn detected this change in the Pharmacy & Controlled Substances space on July 30, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Outsourcing facilities (compounding pharmacies that elect to register with FDA) that compound human drugs. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Fees are due for FY 2027 starting October 1, 2026. Specific payment deadline not stated; check FDA guidance.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmacy & Controlled Substances continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FY 2027 establishment fee set at $18,714 (up from $17,803 in FY 2026) and reinspection fee at $4,679 (up from $4,451).
Who it affects
Outsourcing facilities (compounding pharmacies that elect to register with FDA) that compound human drugs.
What you must do
Pay the applicable establishment fee by the due date (typically October 1, 2026, or upon registration).
Deadline
Fees are due for FY 2027 starting October 1, 2026. Specific payment deadline not stated; check FDA guidance.
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