21 CFR § 203.10 Prescription Drug Marketing

§ 203.10 Restrictions on reimportation.

Current through Sep 8, 2026 · Read all of Part 203

No prescription drug or drug composed wholly or partly of insulin that was manufactured in a State and exported from the United States may be reimported by anyone other than its manufacturer, except that FDA may grant permission to a person other than the manufacturer to reimport a prescription drug or insulin-containing drug if it determines that such reimportation is required for emergency medical care.

← § 203.3 Definitions.§ 203.11 Applications for reimportation to provide emergency medical care. →