Editing Modafinil (section)

===Legal status===
==== Australia ====
In Australia, modafinil is considered to be a [[Standard for the Uniform Scheduling of Medicines and Poisons#Schedule 4: Prescription Only Medicine|Schedule 4]] [[prescription-only medicine]]. This means that it is a drug with a perceived low potential for abuse and low risk of dependence; still, the use of Schedule 4 drugs in Australia is restricted to those who have a valid prescription from a medical practitioner; import from abroad is illegal.<ref name="Legislation.gov.au">{{cite web |title=Poisons Standard March 2018 |date=February 28, 2018 |url=https://www.legislation.gov.au/Details/F2018L00168 |access-date=January 20, 2019 |publisher=Legislation.gov.au |archive-date=August 7, 2020 |archive-url=https://web.archive.org/web/20200807113733/https://www.legislation.gov.au/Details/F2018L00168 |url-status=live }}</ref>

==== Canada ====
In Canada, modafinil is not specifically included in the lists of controlled drugs and substances specified within the [[Controlled Drugs and Substances Act]].<ref name="Canada-Gazette-2005">{{cite news|date=March 26, 2005 |title=Regulations Amending the Food and Drug Regulations (1184 — Modafinil) |newspaper=[[Canada Gazette]] |volume=140 |issue=20 |url=http://gazette.gc.ca/archives/p1/2005/2005-03-26/html/reg5-eng.html |archive-url=https://web.archive.org/web/20110706181716/http://gazette.gc.ca/archives/p1/2005/2005-03-26/html/reg5-eng.html |archive-date=July 6, 2011}}</ref> However, it is classified as a Schedule&nbsp;F prescription drug.<ref name="canada-modafinil-guidance">{{Cite web|url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/guidance-document.html|title=Guidance Document: Determining Prescription Status for Human and Veterinary Drugs| author = Health Canada|date=May 29, 2013|website=www.canada.ca|access-date=February 8, 2024|archive-date=February 8, 2024|archive-url=https://web.archive.org/web/20240208124250/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/guidance-document.html|url-status=live}}</ref><ref name="canada-prescription-drug-list">{{Cite web|url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list.html|title=The Prescription Drug List| author = Health Canada|date=May 29, 2013|website=www.canada.ca|access-date=February 8, 2024|archive-date=June 28, 2023|archive-url=https://web.archive.org/web/20230628231029/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list.html|url-status=live}}</ref><ref name="modafinil-canada-ca">{{Cite web|url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/questions-answers.html|title=Questions and Answers - Prescription Drug List| author = Health Canada|date=May 30, 2013|website=www.canada.ca|access-date=February 8, 2024|archive-date=February 8, 2024|archive-url=https://web.archive.org/web/20240208124251/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/questions-answers.html|url-status=live}}</ref> This means that modafinil can only be obtained legally with a valid prescription from a licensed health care practitioner in Canada, and the import of modafinil to Canada from other countries is subject to restrictions: importing prescription drugs without an import permit may result in the seizure of the drugs at the border, the refusal of entry of the drugs into Canada, or prosecution.<ref name="import-of-modafinil-to-canada">{{cite web | url=https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/personal-use-health-products-guidance/document.html | title=Bringing health products into Canada for personal use (GUI-0116) | date=December 23, 2020 | access-date=January 29, 2024 | archive-date=January 29, 2024 | archive-url=https://web.archive.org/web/20240129173522/https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/personal-use-health-products-guidance/document.html | url-status=live }}</ref>

====China====
In mainland China, modafinil is strictly controlled like other stimulants such as amphetamines and [[methylphenidate]]. It is classified as Class&nbsp;I psychotropic drug. This classification means that modafinil is considered to have a high potential for abuse and dependence, and is therefore subject to strict regulation and control. As a result, modafinil is only available by prescription and cannot be purchased over the counter. In order to obtain a prescription for modafinil, a patient must have a valid medical reason for using the drug, such as [[narcolepsy]] or [[obstructive sleep apnea]]. Additionally, the prescription must be written by a licensed physician and filled at a [[Pharmacy in China|licensed pharmacy]]. The use of modafinil for non-medical purposes, such as with the aim to improve cognitive performance or to stay awake for long periods of time, is strictly prohibited and can result in legal consequences.<ref name="China Food and Drug Administration">{{cite web|title=食品药品监管总局 公安部 国家卫生计生委关于公布麻醉药品和精神药品品种目录的通知 | trans-title = Notice from the Food and Drug Administration, the Ministry of Public Security, and the National Health and Family Planning Commission on publishing the catalog of narcotic drugs and psychotropic drugs | language = zh |publisher=China Food and Drug Administration|url=http://samr.cfda.gov.cn/WS01/CL0844/94735.html |archive-url=https://web.archive.org/web/20181205061404/http://samr.cfda.gov.cn/WS01/CL0844/94735.html|archive-date=December 5, 2018|url-status=dead}}</ref><ref name="China-Modafinil">{{cite web|url=http://www.gov.cn/flfg/2007-03/13/content_549406.htm|title=处方管理办法(原卫生部令第53号)| trans-title = Prescription Management Measures (Former Ministry of Health Order No. 53) |website=中国政府网 (China Government Network) |language=zh|access-date=February 8, 2019|archive-date=February 8, 2020|archive-url=https://web.archive.org/web/20200208155424/http://www.gov.cn/flfg/2007-03/13/content_549406.htm|url-status=live}}</ref>

====Europe====
In Denmark, modafinil is a prescription drug but not listed as a controlled substance. According to the [[Danish Medicines Agency]], modafinil is approved for use in the treatment of narcolepsy, still, importing modafinil to Denmark is considered illegal without a valid prescription.<ref name="Retsinformation.dk-2020">{{cite web |url=https://www.retsinformation.dk/eli/lta/2020/950 |title=Bekendtgørelse om euforiserende stoffer |date=June 23, 2020 |website=Retsinformation.dk |language=da |trans-title=Narcotics act |access-date=October 7, 2020 |archive-date=November 28, 2020 |archive-url=https://web.archive.org/web/20201128175558/https://www.retsinformation.dk/eli/lta/2020/950 |url-status=live }}</ref><ref name="import-dk-1">{{cite web | url=https://laegemiddelstyrelsen.dk/en/pharmacies/medicines-imported-from-abroad/medicines-for-human-use/are-you-bringing-medicine-into-denmark/ | title=Are you bringing medicine into Denmark? | date=August 13, 2018 | access-date=February 5, 2024 | publisher=Danish Medicines Agency | archive-date=January 26, 2024 | archive-url=https://web.archive.org/web/20240126183328/https://laegemiddelstyrelsen.dk/en/pharmacies/medicines-imported-from-abroad/medicines-for-human-use/are-you-bringing-medicine-into-denmark/ | url-status=live }}</ref><ref name="import-dk-2">{{cite web | url=https://laegemiddelstyrelsen.dk/en/pharmacies/medicines-imported-from-abroad/ | title=Medicines imported from abroad | date=March 16, 2022 | access-date=February 5, 2024 | publisher=Danish Medicines Agency | archive-date=January 26, 2024 | archive-url=https://web.archive.org/web/20240126183315/https://laegemiddelstyrelsen.dk/en/pharmacies/medicines-imported-from-abroad/ | url-status=live }}</ref><ref name="Civilstyrelsen-2011">{{cite web|url=https://www.retsinformation.dk/eli/lta/2011/557|title=BEK nr 557 af 31/05/2011, Indenrigs- og Sundhedsministeriet|date=May 31, 2011|access-date=February 5, 2024|publisher=Civilstyrelsen|archive-date=January 26, 2024|archive-url=https://web.archive.org/web/20240126183312/https://www.retsinformation.dk/eli/lta/2011/557|url-status=live}}</ref>

In Finland, modafinil is a prescription drug but not listed as a [[controlled substance]]. Finland is a member of the European Union, and it is illegal to import prescription medicine from outside the European Union unless the person has a valid prescription.<ref name="Finlex.fi-2009">{{cite web|url=https://www.finlex.fi/fi/lainsaadanto/saadoskokoelma/2009/1095|title=Lääkealan turvallisuus- ja kehittämiskeskuksen päätöslääkeluettelosta|date=2009|website=Finlex.fi|access-date=January 3, 2017|archive-date=August 23, 2020|archive-url=https://web.archive.org/web/20200823111409/https://finlex.fi/fi/laki/alkup/2009/20091095|url-status=live}}</ref><ref name="finland-prohibited-goods">{{cite web|url=https://tulli.fi/en/private-persons/ordering-goods-online/prohibited-goods|title=Prohibited goods|publisher=Finnish Customs|access-date=February 5, 2024|archive-date=January 26, 2024|archive-url=https://web.archive.org/web/20240126183313/https://tulli.fi/en/private-persons/ordering-goods-online/prohibited-goods|url-status=live}}</ref><ref name="finland-doping">{{cite web|url=https://dopinglinkki.fi/en/info-bank/doping-substances/modafinil/|title=Modafinil|date=September 19, 2019|access-date=February 5, 2024|website=Dopinglinkki|publisher=A-klinikkasäätiö|archive-date=January 26, 2024|archive-url=https://web.archive.org/web/20240126183315/https://dopinglinkki.fi/en/info-bank/doping-substances/modafinil/|url-status=live}}</ref>

In the Republic of Moldova, modafinil is classified as a psychotropic drug (included in table III list 3 which is the list of psychotropic substances as defined by the [[Government of Moldova]])<ref name="moldova_HG_list_of_substances"/> and is available by prescription.<ref name="moldova_HG_list_of_substances">{{cite web | url = https://www.legis.md/cautare/getResults?doc_id=103676&lang=ro | title = Hotărâre Nr. 79 din 23-01-2006 privind aprobarea Listei substanţelor stupefiante, psihotrope şi a plantelor care conţin astfel de substanţe depistate în trafic ilicit, precum şi cantităţile acestora | trans-title = Decision No. 79 of 01-23-2006 regarding the approval of the List of narcotic, psychotropic substances and plants containing such substances detected in illicit traffic, as well as their quantities | language = Romanian | publisher = Moldavian Ministry of Justice | date = January 23, 2006 | access-date = February 5, 2024 | archive-date = April 3, 2023 | archive-url = https://web.archive.org/web/20230403194451/https://www.legis.md/cautare/getResults?doc_id=103676&lang=ro | url-status = live }}</ref> Importation of modafinil may be considered illegal and subject to severe penalties, even if you have a prescription.<ref name="Customs-Moldova-2023">{{cite web | url = https://customs.gov.md/ro/articles/e-bine-sa-stim-1369-ro | title = Serviciul Vamal al Republicii Moldova – E bine să știm! | trans-title = Customs Service of the Republic of Moldova - Good to know! | language = Romanian | work = Customs Service of the Republic of Moldova | access-date = September 4, 2023 | archive-date = September 4, 2023 | archive-url = https://web.archive.org/web/20230904105420/https://customs.gov.md/ro/articles/e-bine-sa-stim-1369-ro | url-status = live }}</ref> For example, on June 29, 2017, [[Poșta Moldovei|Moldovan postal officers]] discovered 60 tablets of Modalert (200&nbsp;mg modafinil tablets) in a parcel sent from India to a resident in [[Chișinău]], Moldova. The prohibited substance was detected during a routine scan and was seized as illegal. The authorities were notified of the incident and the recipient was charged with criminal penalties.<ref name="modafinil-moldova-2017-discovered-curentul-md">{{cite web|date=June 30, 2007|publisher=curentul.md|vauthors=Parfeni C|url=http://curentul.md/stiri/substante-psihotrope-si-un-pumnal-militar-au-fost-depistate-de-vamesi-in-coletele-postale.html|title=Substanțe psihotrope și un pumnal militar au fost depistate de vameși în coletele poștale|access-date=January 29, 2024|archive-date=January 29, 2024|archive-url=https://web.archive.org/web/20240129202533/http://curentul.md/stiri/substante-psihotrope-si-un-pumnal-militar-au-fost-depistate-de-vamesi-in-coletele-postale.html|url-status=live}}</ref><ref name="modafinil-moldova-2017-discovered-noi-md">{{cite web| publisher=noi.md| date=June 30, 2017| url=https://noi.md/md/news_id/231399| title=Centrul de Sănătate din Edineţ va fi eficientizat energetic| access-date=January 29, 2024| archive-date=January 29, 2024| archive-url=https://web.archive.org/web/20240129202534/https://noi.md/md/news_id/231399| url-status=live}}</ref> In the [[Transnistria]] region of Moldova, modafinil is completely prohibited, due to application of the legislation similar to that of Russia where modafinil is completely prohibited and is in the same list as narcotics. Possession or an attempt to bring modafinil to Transnistria potentially leads to imprisonment.<ref name="base.consultant.ru-2017" />

In Romania, modafinil is classified as a stimulant doping agent and is prohibited in sports competitions.<ref name="ro-antidopink">{{cite web | title = LISTA INTERZISĂ - 2018 | trans-title = Forbidden List - 2018 |work =AGENȚIA NAȚIONALĂ ANTI-DOPING | trans-work = National Anti-Doping Agency | language = Romanian |url=http://anad.gov.ro/web/wp-content/uploads/2017/10/LISTA-2018-web.pdf |archive-date=February 24, 2021 |archive-url=https://web.archive.org/web/20210224105716/http://anad.gov.ro/web/wp-content/uploads/2017/10/LISTA-2018-web.pdf |url-status=dead }}</ref> In 2022, laws were passed making its importation or sale a felony, punishable by three to seven years in jail.<ref name="LEGE 219 26/07/2021 – Portal Legislativ">{{cite web | url=https://legislatie.just.ro/Public/DetaliiDocumentAfis/245003 | title=LEGE 219 26/07/2021 | trans-title = Law 219 26/07/2021 - | work = Portal Legislativ | trans-work = Romanian Legislative Portal| access-date=October 16, 2022 | archive-date=October 16, 2022 | archive-url=https://web.archive.org/web/20221016104753/https://legislatie.just.ro/Public/DetaliiDocumentAfis/245003 | url-status=live | language = Romanian }}</ref> Simple possession for personal use may result in a fine and confiscation.<ref name="LEGE 219 26/07/2021 – Portal Legislativ" />

In Sweden, modafinil is classified as a schedule&nbsp;IV substance, which means that it is considered to have a low potential for abuse and a low risk of dependence. Still, possession is illegal without a prescription.<ref name="LVFS">{{cite web |title=Läkemedelsverkets föreskrifter (LVFS 2011:10) om förteckningar över narkotika | trans-title = The Swedish Medicines Agency's regulations (LVFS 2011: 10) on lists of drugs | language = sv |url=https://lakemedelsverket.se/upload/lvfs/konsoliderade/LVFS_2011_10_konsoliderad_tom_HSLF-FS_2019_7.pdf |archive-url=https://web.archive.org/web/20190807175859/https://lakemedelsverket.se/upload/lvfs/konsoliderade/LVFS_2011_10_konsoliderad_tom_HSLF-FS_2019_7.pdf |archive-date=August 7, 2019 |url-status=dead }}</ref>

In the United Kingdom, it is not listed in [[Misuse of Drugs Act 1971|Misuse of Drugs Act]], so possession is not illegal, but a prescription is required.<ref name="MHRA-2013">{{cite web|url = http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con273748.pdf|title = MHRA license for Modafinil in UK|author = MHRA|date = April 3, 2013|publisher = MHRA|location = London|access-date = April 3, 2013|archive-date = January 22, 2016|archive-url = https://web.archive.org/web/20160122195257/http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con273748.pdf|url-status = live}}</ref>

====Mexico====
In Mexico, modafinil is not listed as a controlled substance, in the National Health Law, and can be purchased in pharmacies without prescription.<ref name="Federal Commission for Protection against Health Risks-2007">{{cite web |title=Estupefacientes y Psicotrópicos |trans-title=Narcotic Drugs and Psychotropic Substances |language=es |publisher=<!--Comisión Federal para la Protección contra Riesgos Sanitarios-->Federal Commission for Protection against Health Risks |url=http://www.cofepris.gob.mx/pyp/estpsic/es.htm |archive-url=https://web.archive.org/web/20070713135452/http://www.cofepris.gob.mx/pyp/estpsic/es.htm |archive-date=July 13, 2007}}</ref>

====Japan====
In Japan, modafinil is Schedule&nbsp;I psychotropic drug. This means that it is considered to have a high potential for abuse and dependence, and is therefore subject to strict regulations. The use of Schedule I drugs in Japan is generally prohibited, except under certain circumstances, such as for medical purposes. It can only be prescribed by a doctor. It cannot be imported or exported without a permit. It cannot be used while driving or operating machinery.<ref name="List of psychotropics">{{cite web|url=http://www.ncd.mhlw.go.jp/img/en/total.pdf|title=List of psychotropics|access-date=May 24, 2019|archive-date=July 11, 2019|archive-url=https://web.archive.org/web/20190711014332/http://www.ncd.mhlw.go.jp/img/en/total.pdf|url-status=dead | work = Narcotics Control Department }}</ref><ref name="Japan-Modafinil">{{cite web |url=http://www.fukushihoken.metro.tokyo.jp/kenkou/iyaku/sonota/shitei_m/moda.html |title=モダフィニルの向精神薬への指定 | trans-title = Designation as a psychotropic drug of Modafinyl | language = Japanese |access-date=January 17, 2017 |archive-url=https://web.archive.org/web/20150515002556/http://www.fukushihoken.metro.tokyo.jp/kenkou/iyaku/sonota/shitei_m/moda.html |archive-date=May 15, 2015 |url-status=dead }}</ref> [[Cephalon]] licensed Alfresa Corporation to produce, and [[Mitsubishi Tanabe Pharma]] to sell modafinil products under the trade name Modiodal in Japan.<ref name="modafinil-japanese">{{cite web|title=医疗用医薬品の添付文书情报-モディオダール锭100mg | trans-title = Attachment of drugs for doctors-Modio Dal 100mg |work = 独立行政法人 医薬品医疗机器総合机 | trans-work = Pharmaceuticals and Medical Devices Agency |url=http://www.info.pmda.go.jp/go/pack/1179047F1022_2_15/ |language=ja|archive-url=https://web.archive.org/web/20190209124042/http://www.info.pmda.go.jp/go/pack/1179047F1022_2_15/|archive-date=February 9, 2019|url-status=dead}}</ref> There have been arrests of people who imported modafinil for personal use.<ref name="Medicallaw.exblog.jp">{{cite web|url=https://medicallaw.exblog.jp/20422896/|title=モダフィニル密輸で逮捕された歯科医師, ダイエットに使用と供述(報道)| trans-title = Dentist who was arrested for Modafinyl smuggling, usage and confidence (report) | language = ja |website=Medicallaw.exblog.jp|access-date=January 20, 2019|archive-url=https://web.archive.org/web/20190121010916/https://medicallaw.exblog.jp/20422896/|archive-date=January 21, 2019|url-status=dead}}</ref><ref name="Hayabusa3.5ch.net">{{cite web|url=https://hayabusa3.5ch.net/test/read.cgi/news/1391949369/|title=向精神薬をインドから密輸入した男を逮捕 | trans-title = Arrested a man who imported psychotropic drugs from India | language = ja |website=Hayabusa3.5ch.net |access-date=January 20, 2019|archive-date=January 21, 2019|archive-url =https://web.archive.org/web/20190121064119/https://hayabusa3.5ch.net/test/read.cgi/news/1391949369/ |url-status=live}}</ref>

====Russia====
In Russia, starting from May 18, 2012, modafinil is Schedule&nbsp;II controlled substance. Being classified as a Schedule II controlled substance in Russia means that it is seen as a drug with a high potential for abuse and dependence. This classification imposes strict regulations on the production, distribution, and use of modafinil. Possession of a few modafinil pills can lead to three to ten years imprisonment. Modafinil is not approved for medical use in Russia and cannot be bought even in pharmacies. It also cannot be imported from abroad, even if you have a prescription issued outside Russia.<ref name="base.consultant.ru-2017">{{cite web |url=http://base.consultant.ru/cons/cgi/online.cgi?req=doc;base=LAW;n=142882;fld=134;dst=4294967295;rnd=0.8965571122244;from=141820-563 |title=Decree of the Government of the Russian Federation of 06.30.1998 N 681 (as amended on 02.26.2013) "On approval of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation" |website=base.consultant.ru |format=PDF |access-date=January 3, 2017 |archive-date=August 28, 2021 |archive-url=https://web.archive.org/web/20210828174157/http://www.consultant.ru/cons/cgi/online.cgi?req=doc&base=LAW&n=142882&fld=134&dst=4294967295&rnd=0.8965571122244&from=141820-563 |url-status=live | language = Russian }}</ref><ref name="Russia-New-Stimulator">{{cite web |title=Россия начнет производить новый стимулятор на базе модафинила |trans-title=Russia will begin to produce a new stimulator based on modafinil |language=ru |url=https://medvestnik.ru/content/news/Rossiya-gotovitsya-proizvodit-novyi-stimulyator-na-baze-modafinila.html |access-date=December 8, 2023 |website=medvestnik.ru |archive-date=December 8, 2023 |archive-url=https://web.archive.org/web/20231208054906/https://medvestnik.ru/content/news/Rossiya-gotovitsya-proizvodit-novyi-stimulyator-na-baze-modafinila.html |url-status=live }}</ref> There are multiple cases of criminal proceedings initiated against Russian residents who tried to import modafinil by mail from abroad.<ref name="SpbPenal2020">{{cite web |date=February 19, 2020 |title=В Петербурге завели дело из-за полученных по почте таблеток от сонливости |trans-title=In St. Petersburg, a case was started because of the pills received by mail from drowsiness |language=ru |url=https://www.rbc.ru/society/19/02/2020/5e4d28499a79473eeeac6613 |access-date=December 8, 2023 |website=РБК (RBC) |archive-date=December 8, 2023 |archive-url=https://web.archive.org/web/20231208054905/https://www.rbc.ru/society/19/02/2020/5e4d28499a79473eeeac6613 |url-status=live }}</ref><ref name="ru-russian-trapped-2023">{{cite web |date=October 11, 2023 |title="Вместо лечения — тюрьма". Россияне с редкими болезнями оказались в ловушке |trans-title="Instead of treatment - a prison." Russians with rare diseases were trapped |url=https://ria.ru/20231011/son-1901816843.html |access-date=December 8, 2023 |website=РИА Новости (Ria News) |language=ru |archive-date=December 8, 2023 |archive-url=https://web.archive.org/web/20231208054905/https://ria.ru/20231011/son-1901816843.html |url-status=live }}</ref>

====South Africa====
In South Africa, modafinil is Schedule&nbsp;V substance, which means that it is legal to use modafinil in South Africa, but only with a valid prescription from a licensed medical practitioner.<ref name="SAFLII-2003">{{cite web|title = GENERAL REGULATIONS MADE IN TERMS OF THE MEDICINES AND RELATED SUBSTANCES ACT 101 OF 1965, AS AMENDED Government Notice R510 in Government Gazette 24727 dated 10 April 2003. 22A/16/b; states that although import and export is restricted, possession is not illegal providing that a prescription is present.|author = SA Government|date = April 10, 2003|publisher = SAFLII|location = Pretoria| url=http://saflii.org/za/legis/consol_reg/marsa101o1965rangnr510723.pdf |archive-url = https://web.archive.org/web/20160422183746/http://saflii.org/za/legis/consol_reg/marsa101o1965rangnr510723.pdf|archive-date = April 22, 2016|url-status = dead}}</ref>

====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>