Modafinil - Legal Status

Legal Status

Modafinil is currently classified as a Schedule IV controlled substance under United States federal law; it is illegal to import by anyone other than a DEA-registered importer without a prescription. However, one may legally bring Modafinil into the United States in person from a foreign country, provided that he or she has a prescription for it, and the drug is properly declared at the border crossing. U.S. residents are limited to 50 dosage units (i.e. pills). Note that Adrafinil, a drug that is closely related to Modafinil, is currently not classified as a controlled substance and therefore is not as severely regulated. Under the US Food and Drug Act, drug companies are not allowed to market their drugs for off-label uses (conditions other than those officially approved by the FDA); Cephalon was reprimanded in 2002 by the FDA because its promotional materials were found to be "false, lacking in fair balance, or otherwise misleading". Cephalon pled guilty to a criminal violation and paid several fines, including $50 million and $425 million fines to the U.S. government in 2008.

The following countries do not classify Modafinil as a controlled substance:

• Canada (not listed in the Controlled Drugs and Substances Act, but it is a Schedule F prescription drug, so it is subject to seizure by Canada Border Services Agency)
• Mexico
• United Kingdom (not listed in the Misuse of Drugs Act and is available without legal restrictions by prescription)
• Australia (listed as a Schedule 4 prescription drug)
• In Germany the classification has been changed from controlled substance (BtM) to prescription drug (RP) effective March 1, 2008.
• In India, generic retailing as Modalert is available from Sun Pharmaceuticals; Indian firms are not required to respect patents filed before 1995.

Currently, use of modafinil is controversial in the sporting world, with high profile cases attracting press coverage since several prominent American athletes have tested positive for the substance (see Modafinil as a doping agent). Some athletes who were found to have used modafinil protested that the drug was not on the prohibited list at the time of their offenses. However, the World Anti-Doping Agency (WADA) maintains that it was related to already banned substances. The Agency added modafinil to its list of prohibited substances on August 3, 2004, ten days before the start of the 2004 Summer Olympics.