Controlled Substances Act: Difference between revisions

| effective date = May 1, 1971

| title amended  = [[Title 21 of the United States Code|21 U.S.C.: Food and Drugs]]11

| introducedby    = [[Harley O. Staggers]] ([[Democratic Party (United States)|D]]–[[West Virginia|WV]])

| committees      = [[United States House Committee on Energy and Commerce|Interstate and Foreign Commerce Committee]] and [[United States Senate Committee on the Judiciary|Senate Judiciary Committee]]

The '''Controlled Substances Act''' ('''CSA''') is the statute establishing [[federal government of the United States|federal]] [[drug policy of the United States|U.S. drug policy]] under which the manufacture, importation, possession, use, and distribution of certain substances is regulated. It was passed by the [[91st United States Congress]] as Title II of the [[Comprehensive Drug Abuse Prevention and Control Act of 1970]] and signed into law by President [[Richard Nixon]].<ref>{{USStatute|91|513|84|1236|1970|10|27}}, codified at {{usc|21|801}} et. seq.</ref> The Act also served as the national implementing legislation for the [[Single Convention on Narcotic Drugs]].

The legislation created five schedules (classifications), with varying qualifications for a substance to be included in each. Two federal agencies, the [[Drug Enforcement Administration]] (DEA) and the [[Food and Drug Administration]] (FDA), determine which substances are added to or removed from the various schedules, although the statute passed by Congress created the initial listing. Congress has sometimes scheduled other substances through legislation such as the [[Hillory J. Farias and Samantha Reid Date-Rape Prevention Act of 2000]], which placed [[gamma hydroxybutyrate]] (GHB) in Schedule I and [[sodium oxybate]] (the isolated sodium salt in GHB) in [[Schedule III controlled substance|Schedule III]] when used under an FDA [[New Drug Application]] (NDA) or [[Investigational New Drug]] (IND).<ref>{{cite web|title=2000 - Addition of Gamma-Hydroxybutyric Acid to Schedule I|url=https://www.deadiversion.usdoj.gov/fed_regs/rules/2000/fr0313.htm|publisher=US Department of Justice via the Federal Register|date=March 13, 2000|access-date=April 16, 2018|archive-date=May 1, 2021|archive-url=https://web.archive.org/web/20210501154805/https://www.deadiversion.usdoj.gov/fed_regs/rules/2000/fr0313.htm|url-status=dead}}</ref><ref>{{cite web|title=William J. Clinton: Statement on Signing the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000|url=http://www.presidency.ucsb.edu/ws/index.php?pid=58098|date=February 18, 2000}}</ref> Classification decisions are required to be made on criteria including potential for abuse (an undefined term),<ref name=":1" /> currently accepted medical use in treatment in the United States, and international treaties.

The nation first outlawed addictive drugs in the early 1900s and the [[International Opium Convention]] helped lead international agreements regulating trade.<ref>{{cite web |url=http://www.deamuseum.org/museum_ida.html |title=Illegal Drugs in America: A Modern History |website=DEA Museum & Visitors Center |archive-url=https://web.archive.org/web/20041204213309/http://www.deamuseum.org/museum_ida.html |archive-date=December 4, 2004}}</ref><ref>{{cite book |contribution-url=http://www.druglibrary.org/schaffer/library/studies/canadasenate/vol3/chapter19_hague.htm |title=Public Policy Options |url=http://www.druglibrary.org/schaffer/library/studies/canadiansenate/vol2_table_of_contents.htm |series=Canadian Senate Special Committee on Illegal Drugs |volume=3 |contribution=The 1912 Hague International Opium Convention |publisher=Schaffer Library of Drug Policy }}{{Dead link|date=March 2023 |bot=InternetArchiveBot |fix-attempted=yes}}</ref><ref>{{cite web |url=http://www.druglibrary.org/schaffer/history/ophs.htm |last=Musto |first=David F. |title=History of Legislative Control Over Opium, Cocaine, and Their Derivatives |website=Schaffer Library of Drug Policy }}</ref> The [[Pure Food and Drug Act]] (1906) was the beginning of over 200 laws concerning public health and consumer protections.<ref>{{cite web |url=https://www.fda.gov/RegulatoryInformation/Legislation/default.htm |archive-url=https://web.archive.org/web/20090531213346/http://www.fda.gov/RegulatoryInformation/Legislation/default.htm |url-status=dead |archive-date=May 31, 2009 |title=Legislation |website=U.S. Food and Drug Administration |date=July 2, 2015}}</ref> Others were the [[Federal Food, Drug, and Cosmetic Act]] (1938), and the [[Kefauver Harris Amendment]] of 1962.<ref>{{cite web |url=http://rx-wiki.org/index.php?title=Medical_Device_Amendments |title=Medical Device Amendments |access-date=December 30, 2012 |website=Rx-wiki |publisher=Parsons Printing Press}}</ref>

Rufus King notes that this stratagem was similar to that used by [[Harry Anslinger]] when he consolidated the previous anti-drug treaties into the Single Convention and took the opportunity to add new provisions that otherwise might have been unpalatable to the international community.<ref name="dontsit">{{cite book |chapter-url=http://www.druglibrary.net/special/king/dhu/dhu28.htm |chapter=The 1970 Act: Don't Sit There, Amend Something |last=King |first=Rufus |title=The Drug Hang Up, America's Fifty-Year Folly |url=http://www.druglibrary.net/special/king/dhu/dhumenu.htm |publisher=Schaffer Library of Drug Policy}}</ref> According to David T. Courtwright, "the Act was part of an omnibus reform package designed to rationalize, and in some respects to liberalize, American drug policy." (Courtwright noted that the Act became, not [[Libertarianism|libertarian]], but instead repressionistic to the point of tyrannical in its intent; a cruel and/or arbitrary exercise of power). It eliminated mandatory minimum sentences and provided support for drug treatment and research.<ref>{{cite journal |title=The Controlled Substances Act: how a "big tent" reform became a punitive drug law |last=Courtwright |first=David T. |date=October 5, 2004 |journal=Drug and Alcohol Dependence |volume=76 |issue=1 |pages=9–15 |pmid=15380284 |doi=10.1016/j.drugalcdep.2004.04.012}}</ref>

# In 2018 the act was also [https://www.ecfr.gov/current/title-21/chapter-II/part-1308/subject-group-ECFRf62f8e189108c4d/section-1308.11#p-1308.11(h)(i) amended to describe and control all chemical space related to Fentanyl like chemicals] using Markush like notation, the first time Markush like statement were directly used in the act itself

The Congressional findings in [[21 USC]] §§ {{USCSub2|21|801|7}}, {{USCSub2|21|801a|2}}, and {{USCSub2|21|801a|3}} state that a major purpose of the CSA is to "enable the United States to meet all of its obligations" under international [[treaty|treaties]]. The CSA bears many resemblances to these Conventions. Both the CSA and the treaties set out a system for classifying controlled substances in several schedules in accordance with the binding scientific and medical findings of a public health authority. Under {{usc|21|811}} of the CSA, that authority is the [[Secretary of Health and Human Services]] (HHS). Under Article 3 of the Single Convention and Article 2 of the Convention on Psychotropic Substances, the [[World Health Organization]] is that authority.

According to the Cato Institute, these treaties only bind (legally obligate) the United States to comply with them as long as that nation agrees to remain a state party to these treaties. The [[Congress of the United States|U.S. Congress]] and the [[President of the United States]] have the absolute [[Sovereignty|sovereign]] right to withdraw from or abrogate at any time these two instruments, in accordance with said nation's [[Constitution of the United States|Constitution]], at which point these treaties will cease to bind that nation in any way, shape, or form.<ref name="cato.org">{{cite book |chapter-url=http://www.cato.org/pubs/handbook/hb108/hb108-17.pdf |title=Cato Handbook for Congress: Policy Recommendations for the 108th Congress |chapter=The War on Drugs |pages=171–178 |year=2003 |publisher=Cato Institute |access-date=October 20, 2012 |archive-date=October 7, 2012 |archive-url=https://web.archive.org/web/20121007031243/http://www.cato.org/pubs/handbook/hb108/hb108-17.pdf |url-status=dead }}</ref>

! scope="col" | Potential for Abuse

! scope="col" | Accepted Medical Use?

! scope="col" | Potential for Addiction

Placing a drug or other substance in a certain schedule or removing it from a certain schedule is primarily based on [[21 USC]] §§ {{uscsub2|21|801}}, {{uscsub2|21|801a}}, {{uscsub2|21|802}}, {{uscsub2|21|811}}, {{uscsub2|21|812}}, {{uscsub2|21|813}}, and {{uscsub2|21|814}}. Every schedule otherwise requires finding and specifying the "potential for abuse" before a substance can be placed in that schedule.<ref>{{cite web|url=http://www4.law.cornell.edu/uscode/html/uscode21/usc_sup_01_21_10_13.html|title=21 U.S. Code Chapter 13 - Drug Abuse Prevention and Control |website=LII / Legal Information Institute}}</ref> The specific classification of any given drug or other substance is usually a source of controversy, as is the purpose and effectiveness of the entire regulatory scheme.

* [[alpha-Methyltryptamine|αMT]] (alpha-methyltryptamine), a [[psychedelic drug|psychedelic]], [[stimulant]], and [[entactogen]] [[drug]] of the [[tryptamine]] class that was originally developed as an antidepressant by workers at [[Upjohn]] in the 1960s.

* [[Dimethyltryptamine|DMT]] (dimethyltryptamine), a naturally occurring [[psychedelic drug]] that is widespread throughout the plant kingdom and endogenous to the human body. DMT is the main psychoactive constituent in the [[psychedelic drug|psychedelic]] South American brew, [[ayahuasca]], for which the [[União do Vegetal|UDV]] are granted exemption from DMT's schedule I status on the grounds of religious freedom.

* [[Gamma-hydroxybutyric acid|GHB]] (gamma-Hydroxybutyric acid), a general anesthetic and treatment for [[narcolepsy]]-cataplexy and alcohol withdrawal with a limited safe dosage range and poor ability to control pain when used as an anesthetic (severely limiting its usefulness).<ref>{{cite journal | last1 = Tunnicliff | first1 = G. | year = 1997 | title = Sites of action of gamma hydroxybutyrate (GHB)—A neuroactive drug with abuse potential | journal = Clinical Toxicology | volume = 35 | issue = 6| pages = 581–590 | doi = 10.3109/15563659709001236 | pmid = 9365423 }}</ref> It was placed in Schedule I in March 2000 after widespread recreational use led to increased [[emergency room]] visits, hospitalizations, and deaths.<ref>{{Cite journal |last1=Okun |first1=M. S. |last2=Boothy |first2=L. A. |last3=Bartfield |first3=R. B. |last4=Doering |first4=P. L. |year=2001 |title=GHB: An important pharmacologic and clinical update |journal= Journal of Pharmacy & Pharmaceutical Sciences |volume=4| issue = 2 |pages=167–175|pmid=11466174 }}</ref> A specific formulation of this drug is also listed in Schedule III for limited uses, under the trademark [[Xyrem]].

* [[Heroin]] is the brand name for ''diacetylmorphine'' or ''morphine diacetate'', which is an inactive [[prodrug]] that exerts its effects after being converted into the major active metabolite morphine, and the minor metabolite 6-MAM - which itself is also rapidly converted to morphine. Some European countries still use it as a potent pain reliever in terminal cancer patients, and as second option, after [[morphine|morphine sulfate]]; it is about twice as potent, by weight, as morphine and, indeed, becomes morphine upon injection into the bloodstream. The two acetyl groups attached to the morphine make a prodrug which delivers morphine to the opioid receptors twice as fast as morphine can.

* [[Lysergic acid diethylamide|LSD]] (lysergic acid diethylamide), a [[semi-synthetic]] [[psychedelic drug]] famous for its involvement in the [[counterculture of the 1960s]].

* [[Cannabis (drug)|Marijuana]] and its [[cannabinoid]]s. Pure (–)-trans-Δ9-tetrahydrocannabinol is also listed in Schedule III for limited uses, under the trademark [[Marinol]]. As a result of ballot initiatives, [[Legality of cannabis by U.S. jurisdiction|many states]] have made recreational and medical use of marijuana legal, while other states have decriminalized possession of small amounts. Such measures operate only on state laws, and have no effect on federal law.<ref name=donnie /><ref name=Angelos>See ''United States v. Angelos'', 433 F.3d 738 ([[United States Court of Appeals for the Tenth Circuit|10th Cir.]] 2006) (55 years for three sales of marijuana).</ref> Whether such users would actually be prosecuted under federal law is a separate question with no definitive answer. Given the widespread medicinal use of cannabis, the maintenance of its Schedule I classification has been controversial, with many calling for a reclassification or holistic federal decriminalization. As of April 30, 2024, cannabis was set to be reclassified by the [[Drug Enforcement Administration|DEA]] as a Schedule III controlled substance.<ref>{{Cite web |title=Biden administration plans to drastically change federal rules on marijuana |url=https://www.usatoday.com/story/news/nation/2024/04/30/dea-reclassifies-marijuana-reports/72865632007/ |access-date=April 30, 2024 |website=USA TODAY |language=en-US}}</ref><ref>{{Cite web |date=April 30, 2024 |title=US drug control agency will move to reclassify marijuana in a historic shift, AP sources say |url=https://apnews.com/article/marijuana-biden-dea-criminal-justice-pot-f833a8dae6ceb31a8658a5d65832a3b8 |access-date=April 30, 2024 |website=AP News |language=en}}</ref>

* [[MDMA]] ("ecstasy" or "molly"), a [[stimulant]], [[psychedelic drug|psychedelic]], and [[Empathogen-entactogen|entactogenic]] drug which initially garnered attention in [[psychedelic therapy]] as a treatment for [[post-traumatic stress disorder]] (PTSD). The medical community originally agreed upon placing it as a Schedule III substance, but the government denied this suggestion, despite two court rulings by the DEA's administrative law judge that placing MDMA in Schedule I was illegal. It was temporarily unscheduled after the first administrative hearing from December 22, 1987 – July 1, 1988.<ref>{{cite web|url=http://maps.org/dea-mdma/|title=MAPS Legal History of MDMA|access-date=October 30, 2014|archive-date=August 5, 2007|archive-url=https://web.archive.org/web/20070805015508/http://maps.org/dea-mdma/|url-status=dead}}</ref>

* [[Mescaline]], a naturally occurring [[psychedelic drug]] and the main psychoactive constituent of [[peyote]] (''Lophophora williamsii''), [[Echinopsis pachanoi|San Pedro cactus]] (''Echinopsis pachanoi''), and [[Echinopsis peruviana|Peruvian torch cactus]] (''Echinopsis peruviana'').

In addition to the named substance, usually all possible ethers, esters, salts and stereoisomers of these substances are also controlled and also 'analogues', which are chemically similar chemicals.

* [[Amphetamine]] drugs including [[Adderall]], [[Dextroamphetamine]] (Dexedrine), [[Lisdexamfetamine]] (Vyvanse): treatment of [[ADHD]], [[narcolepsy]], severe [[obesity]] (limited use, dextroamphetamine only), [[binge eating disorder]] (lisdexamfetamine only). Originally placed in Schedule III, but moved to Schedule II in 1978 as part of the [[Psychotropic Substances Act (United States)|Psychotropic Substances Act]].

* [[Hydrocodone]] in ''any'' formulation since October 2014 (examples include Vicodin, Norco, Tussionex). Prior to October 2014, formulations containing hydrocodone and over-the-counter [[analgesic]]s such as [[Paracetamol|Acetaminophen]] and [[Ibuprofen]] were Schedule III.<ref>Federal Register / Vol. 79, No. 163 / Pgs. 49661 - 49682 / August 22, 2014, DEA-Final Rule, Effective October 6, 2014 [https://www.gpo.gov/fdsys/pkg/FR-2014-08-22/html/2014-19922.htm Text (162 KB)] [https://www.gpo.gov/fdsys/pkg/FR-2014-08-22/pdf/2014-19922.pdf PDF (242 KB)]</ref>

* [[Methylphenidate]] (Ritalin, Concerta), [[Dexmethylphenidate]] (Focalin): treatment of [[ADHD]], [[narcolepsy]]

* [[Opium]] tincture ([[Laudanum]]): a potent [[antidiarrheal]]

* [[Pentobarbital|Nembutal (Pentobarbital)]] – [[barbiturate]] medication originally developed for [[narcolepsy]]; primarily used today for [[Assisted suicide|physician assisted suicide]] and [[euthanasia]] of animals.

* [[Phencyclidine]] (PCP) - Formerly used as veterinary anesthetic under the trade name Sernylan and before then as an injectable anesthetic under the trade name Sernyl.<ref>{{cite web |url=https://www.unodc.org/LSS/SubstanceGroup/Details/6bf165ed-82e7-47e0-9eaa-daacc42d99cd |title=Details for Phencyclidine-type substances}}</ref>

* FDA-approved [[sodium oxybate]] products (e.g. Xyrem, Xywav and Lumryz)—preparations of [[gamma-Hydroxybutyric acid|GHB]] used to treat [[narcolepsy]]. These products are in Schedule III but with a [[Risk Evaluation and Mitigation Strategies|restricted distribution system]]. All other forms or preparations of GHB are in Schedule I.

* [[Tetrahydrocannabinol|Marinol]], synthetically prepared [[tetrahydrocannabinol]] (officially referred to by its [[International Nonproprietary Name|INN]], [[tetrahydrocannabinol|dronabinol]]) used to treat [[nausea]] and [[vomiting]] caused by [[chemotherapy]], as well as [[Anorexia (symptom)|appetite loss]] caused by [[AIDS]].

* [[Phendimetrazine]] Tartrate, a stimulant synthesized for use as an [[anorexiant]].

* [[Ergine]] (lysergic acid amide), listed as a sedative but also has psychedelic effects such as visual and auditory effects.<ref>{{cite journal | last1 = Halpern | first1 = J.H. | year = 2004 | title = Hallucinogens and dissociative agents naturally growing in the United States | journal = Pharmacology & Therapeutics | volume = 102 | issue = 2| pages = 131–138 | doi=10.1016/j.pharmthera.2004.03.003 | pmid=15163594| s2cid = 30734515 }}</ref><ref>Schultes, R.E. and Hofmann, A., 1980. ''The botany and chemistry of hallucinogens'', Charles C. Thomas, Springfield, IL.</ref> An inefficient precursor to its ''N'', ''N''-diethyl analogue, [[Lysergic acid diethylamide|LSD]], ergine occurs naturally in the seeds of the common garden flowers ''[[Turbina corymbosa]]'', ''[[Ipomoea tricolor]]'', and ''[[Argyreia nervosa]]''.

* [[Benzodiazepine]]s, such as [[alprazolam]] (Xanax), [[chlordiazepoxide]] (Librium), [[clonazepam]] (Klonopin), [[diazepam]] (Valium), [[midazolam]] (Versed), and [[Lorazepam]] (Ativan), as well as:

* [[Suvorexant]] and [[Lemborexant]], [[Hypocretin (orexin) receptor 1|orexinergic]] sedatives

These psychoactive drugs are not controlled by the act, and are also allowed for sale intended for [[recreational drug use|recreational use]] at the federal level (others are allowed for sale as [[dietary supplement]]s, but not specifically regulated or intended for recreational use):

* [[Caffeine]], a stimulant found in [[coffee]], [[chocolate]]; and some [[tea]]s and [[soft drink]]s. It is regulated by the FDA under the [[Federal Food, Drug, and Cosmetic Act]], and drinks cannot contain more than 200 parts per million (0.02%) of caffeine. There is no federal age restriction for caffeine-containing products.<ref>{{cite journal |last1=Rosenfeld |first1=Leah S. |last2=Mihalov |first2=Jeremy J. |last3=Carlson |first3=Susan J. |last4=Mattia |first4=Antonia |title=Regulatory status of caffeine in the United States |journal=Nutrition Reviews |date=October 2014 |volume=72 |issue=Suppl 1 |pages=23–33 |doi=10.1111/nure.12136 |pmid=25293541 |issn=1753-4887|doi-access=free }}</ref> Also available medically in some pain medications (usually in combination with other drugs, like in [[aspirin/paracetamol/caffeine|aspirin/acetaminophen/caffeine]]).

Starting in 2012, with the [[Synthetic Drug Abuse Prevention Act|Synthetic drug abuse prevention act]], and later an amendment to the CSA in 2018 [https://www.ecfr.gov/current/title-21/chapter-II/part-1308/subject-group-ECFRf62f8e189108c4d/section-1308.11#p-1308.11(h)(i) defining fentanyl chemical space], the CSA started to use [[Markush structure|Markush]] descriptions to clearly define what analogues or chemical space is controlled. These chemical space, chemical family, generic statements or markush statements (depending on the legislation terminology) have been used for many years by other countries,<ref>{{Cite web |title=An overview of chemical space laws and controlled drugs |url=https://blog.scitegrity.com/news/controlled-substances-lists-and-chemical-families}}</ref> notably the UK in the [[Misuse of Drugs Act 1971|Misuse of Drugs Act]].  

The CSA does not include a definition of "drug abuse".<ref name="regulations.gov">[http://www.regulations.gov/#!docketDetail;D=DEA-2009-0013 Government Regulations] Docket ID: DEA-2009-0013 in [http://www.regulations.gov/#!documentDetail;D=DEA-2009-0013-0003 Basis for the Recommendation to Control 5-Methoxy-Dimethyltryptamine (5-MeO-DMT) in Schedule I of the Controlled Substances Act] The term "abuse" is not defined in the CSA.</ref><ref name="Drug Abuse 1973 p.13">"[D]rug abuse may refer to any type of drug or chemical without regard to its pharmacologic actions. It is an eclectic concept having only one uniform connotation: societal disapproval. ... The Commission believes that the term drug abuse must be deleted from official pronouncements and public policy dialogue. The term has no functional utility and has become no more than an arbitrary codeword for that drug use which is presently considered wrong." – Second Report of the National Commission on Marihuana and Drug Abuse; Drug Use In America: Problem In Perspective (March 1973), p.13</ref> In addition, research shows certain substances on Schedule I, for drugs which have no accepted medical uses and high potential for abuse, actually have accepted medical uses, have low potential for abuse, or both.<ref>{{cite web |title=Drug Scheduling |publisher=Drug Enforcement Administration, United States Department of Justice |url=https://www.dea.gov/druginfo/ds.shtml |access-date=August 18, 2016 |archive-url=https://web.archive.org/web/20170809044016/https://www.dea.gov/druginfo/ds.shtml |archive-date=August 9, 2017 |url-status=dead}}</ref><ref>{{cite journal |last1=Nutt |first1=David J. |last2=King |first2=Leslie A. |last3=Phillips |first3=Lawrence D. |author4=Independent Scientific Committee on Drugs |date=November 6, 2010 |title=Drug harms in the UK: A multicriteria decision analysis |journal=The Lancet |volume=376 |issue=9752 |pages=1558–1565 |pmid=21036393 |doi=10.1016/S0140-6736(10)61462-6 |citeseerx=10.1.1.690.1283 |s2cid=5667719}}</ref><ref>{{cite web |title=DrugFacts: Is Marijuana Medicine? |date=July 2015 |website=National Institute on Drug Abuse |publisher=National Institutes of Health; U.S. Department of Health and Human Services |url=http://www.drugabuse.gov/publications/drugfacts/marijuana-medicine}}</ref> One of those substances is cannabis, Which is legal for medical use in 40 states, Legal for recreational in 24 states, and decriminalized in 8 states, one of which being North Carolina which has neither medical or recreational legalized [[Legality of cannabis by U.S. jurisdiction]]