FDA License to Operate (LTO)
Establishment-level certification · Required before any product registration
The LTO authorizes a business establishment to handle regulated health products. It must be obtained before any product registration or notification can be filed — making it the first and most critical step for entering the market with food, drug, cosmetic, or medical device products. The LTO covers the establishment, not the individual products.
Applies to
- Manufacturers
- Importers
- Distributors
- Drug establishments
- Cosmetic establishments
- Medical device establishments
- Food establishments
FDA LTO — New ApplicationRequired first
FDA LTO — Renewal
FDA LTO — Variation (address / establishment details)
FDA LTO — ConsigneeNew
Pharmacist for FDA Compliance (Outsourced)
Renewal must be filed before expiration. Operating with an expired LTO can result in establishment closure, product recall, and administrative sanctions.