What is the FDA establishment registration fee for 2026?
FDA does not charge one universal establishment registration fee. For pharmaceutical drug establishments, basic registration under 21 CFR Part 207 generally has no standalone fee, while specific programs—including generic drugs, outsourcing facilities, and medical devices—have separate FY 2026 fees.
Answer
The FDA establishment registration fee for fiscal year 2026 depends on the regulated product and facility activity. A conventional prescription or OTC drug establishment does not pay a single general fee merely to submit its basic drug-establishment registration. However, other statutory user-fee programs may apply.
For generic drug facilities subject to GDUFA, FY 2026 annual fees include:
Domestic API facility: $43,549
Foreign API facility: $58,549
Domestic finished-dosage-form facility: $238,943
Foreign finished-dosage-form facility: $253,943
Domestic contract manufacturing organization: $57,346
Foreign contract manufacturing organization: $72,346
These fees apply from October 1, 2025, through September 30, 2026, to facilities meeting the applicable GDUFA definitions. The complete schedule appears in FDA’s FY 2026 generic drug user-fee notice.
Registered 503B outsourcing facilities have different FY 2026 establishment fees: $20,726 for non-small businesses and $6,829 for qualifying small businesses.
The frequently quoted $11,423 FY 2026 establishment registration fee applies to medical device establishments, not conventional pharmaceutical drug registration. FDA established that amount in its FY 2026 medical device user-fee notice.
Businesses must therefore identify their regulatory category before calculating costs. Establishment registration, product listing, application review, facility fees, and program fees are legally distinct obligations.
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