In the United States, modafinil is classified as a schedule IV controlled substance under US federal law. This means that the drug has a low potential for abuse and dependence compared to other controlled substances. However, it still requires a prescription from a licensed healthcare provider to obtain.
It is illegal to import modafinil to the United States without a Drug Enforcement Administration (DEA)-registered importer and a prescription. Individuals may legally bring modafinil into the US from a foreign country for personal use, limited to 50 dosage units, with a prescription and proper declaration at the border. Under the Pure Food and Drug Act, marketing drugs for off-label uses is prohibited. Cephalon, the manufacturer of Provigil, faced legal issues for promoting off-label uses and paid significant fines in 2008.