Outsourcing Facility Fee Rates for Fiscal Year 2027
FDA published FY 2027 fee rates for outsourcing facilities (503B compounders). The annual establishment fee is $18,714 and the reinspection fee is $4,679 per reinspection. These rates apply to the fiscal year beginning October 1, 2026.
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 Medium urgency. All registered outsourcing facilities (503B compounders) and entities considering registration. should confirm how it applies to their specific situation before acting. There is a time constraint attached: October 1, 2026 (start of FY 2027) – fees are due for the 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
FY 2027 annual establishment fee set at $18,714 (up from $17,823 in FY 2026) and reinspection fee at $4,679 (up from $4,456).
Who it affects
All registered outsourcing facilities (503B compounders) and entities considering registration.
What you must do
Pay the annual establishment fee by the deadline (typically October 1, 2026 or upon registration). Ensure budget includes the new rates.
Deadline
October 1, 2026 (start of FY 2027) – fees are due for the fiscal year.
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