Compounding Pharmacies: FDA's 2026 Fee Squeeze Hits Hard
Published Date: 7/30/2025
Notice
Summary
If you run a drug-compounding outsourcing facility, the FDA just set the fees for fiscal year 2026. Small businesses will pay $6,829, while bigger ones owe $20,726, plus $20,486 for any reinspections. These fees help keep drug safety in check, so get ready to pay on time and keep your facility in tip-top shape!
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
Small Business Establishment Fee Set
If you run a drug‑compounding outsourcing facility and are classified as a small business, the FDA set the FY 2026 annual establishment fee at $6,829. This is the yearly amount your facility must pay to be registered as an outsourcing facility under the Federal Food, Drug, and Cosmetic Act.
Non‑Small Business Establishment Fee
If you run a drug‑compounding outsourcing facility that is not a small business, the FDA set the FY 2026 annual establishment fee at $20,726. This is the yearly fee larger outsourcing facilities must pay to be registered under the Federal Food, Drug, and Cosmetic Act.
Reinspection Fee Charged Per Reinspection
If your outsourcing facility is reinspected, the FDA set the FY 2026 reinspection fee at $20,486 for each reinspection. You must pay this fee for every reinspection conducted during FY 2026.
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