Editing Modafinil (section)

====United States====
In the United States, modafinil is classified as a [[Controlled Substances Act|schedule IV controlled substance]]<ref name="modafinil-schedule-IV-1999"/> under US federal law.<ref name="Provigil FDA label" /><ref name="Pharmaceutical Press-2017">{{cite book |title=BNF 74 |date=September 2017 |publisher=Pharmaceutical Press |isbn=978-0-85711-298-9 |page=468 |edition=74}}</ref> 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 [[Health care provider|licensed healthcare provider]] to obtain.<ref name="Pharmaceutical Press-2017"/>

It is illegal to import modafinil to the United States without a [[Drug Enforcement Administration]] ([[Drug Enforcement Administration|DEA]])–registered importer and a prescription.<ref name="United States Drug Enforcement Administration-info-modafinil-2007">{{Cite web |title=Is It Illegal to Obtain Controlled Substances from the Internet? |url=http://www.usdoj.gov/dea/illegal_internet.html |url-status=dead |archive-url=https://web.archive.org/web/20070709032821/http://www.usdoj.gov/dea/illegal_internet.html |archive-date=July 9, 2007 |publisher=[[United States Drug Enforcement Administration]] |access-date=July 21, 2007}}</ref> 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.<ref name="United States Department of Justice-1997">{{cite web |date=March 24, 1997 |title=USC 201 Section 1301.26 Exemptions from import or export requirements for personal medical use |url-status=dead |archive-url=https://web.archive.org/web/20070203125143/http://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_26.htm |archive-date=February 3, 2007 |access-date=January 10, 2007 |publisher=[[United States Department of Justice]]|url=http://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_26.htm }}</ref> Under the [[Pure Food and Drug Act]], marketing drugs for off-label uses is prohibited.<ref name="FDA-DMA-1987">{{cite web |title=Prescription Drug Marketing Act of 1987 (PDMA), PL 100-293 |archive-url=https://web.archive.org/web/20080223233036/https://www.fda.gov/opacom/laws/pdma.html |archive-date=February 23, 2008 |publisher=U.S. [[Food and Drug Administration]] (FDA) |url=https://www.fda.gov/opacom/laws/pdma.html }}</ref> Cephalon, the manufacturer of Provigil, faced legal issues for promoting off-label uses and paid significant fines in 2008.<ref name="Allison-2009">{{cite web |vauthors=Allison J |date=October 9, 2009 |title=Class Action Over Cephalon Off-Label Claims Tossed |url=https://www.law360.com/articles/127434 |publisher=Law360 |quote=Cephalon executives have repeatedly said that they do not condone off-label use of Provigil, but in 2002 the company was reprimanded by the FDA for distributing marketing materials that presented the drug as a remedy for tiredness, "decreased activity" and other supposed ailments. In 2008, Cephalon paid $425m and pleaded guilty to a federal criminal charge relating to its promotion of off-label uses for Provigil and two other drugs. |access-date=January 12, 2022 |archive-date=April 30, 2022 |archive-url=https://web.archive.org/web/20220430201243/https://www.law360.com/articles/127434 |url-status=live }}</ref>