The Controlled Substances Act (CSA): A Legal Overview for the 119th Congress

Changes from February 5, 2021 to January 19, 2023

This page shows textual changes in the document between the two versions indicated in the dates above. Textual matter removed in the later version is indicated with ~~red strikethrough~~ and textual matter added in the later version is indicated with blue.

The Controlled Substances Act (CSA):
~~February 5, 2021~~January 19, 2023
A Legal Overview for the ~~117th~~118th Congress
Joanna R. Lampe
The Controlled Substances Act (CSA) establishes a unified legal framework to regulate certain The Controlled Substances Act (CSA) establishes a unified legal framework to regulate certain
Legislative Attorney Legislative Attorney
drugs that are deemed to pose a risk of abuse and dependence. The CSA may apply to drugs that drugs that are deemed to pose a risk of abuse and dependence. The CSA may apply to drugs that

are medical or recreational, legally or illicitly distributed, but the statute does not apply to all are medical or recreational, legally or illicitly distributed, but the statute does not apply to all
drugs. Rather, it applies to drugs. Rather, it applies to ~~specific substances and categories of~~drugs and other substances that have been substances that have been

designated for control by designated for control by Congress or through administrative proceedings. The CSA also applies Congress or through administrative proceedings. The CSA also applies
to to controlled substance analogues that are intended to mimic the effects of controlled substances and to certain that are intended to mimic the effects of controlled substances and to certain listed chemicals—precursor
chemicals commonly used commonly used ~~in the manufacturing of~~to manufacture controlled substances. controlled substances.
Controlled substances subject to the CSA are divided into categories known as Schedules I through V based on their medical Controlled substances subject to the CSA are divided into categories known as Schedules I through V based on their medical
utility and their potential for abuse and dependence. Substances considered to pose the greatest risk to the public health and utility and their potential for abuse and dependence. Substances considered to pose the greatest risk to the public health and
safety are subject to the most stringent controlssafety are subject to the most stringent controls and sanctions. A lower schedule number corresponds to greater restrictions, and sanctions. A lower schedule number corresponds to greater restrictions,
so substances in Schedule I are subject to the strictest controls, while substances in Schedule V are subject to the least strict. so substances in Schedule I are subject to the strictest controls, while substances in Schedule V are subject to the least strict.
Many substances regulated under the CSA are also subject to other federal or state regulations, including the Federal Food, Many substances regulated under the CSA are also subject to other federal or state regulations, including the Federal Food,
Drug, and Cosmetic ActDrug, and Cosmetic Act ~~(FD&C Act)~~. .
The Drug Enforcement Administration (DEA) is the federal agency primarily responsible for implementing and enforcing the The Drug Enforcement Administration (DEA) is the federal agency primarily responsible for implementing and enforcing the
CSA. DEA may designate a substance for control through notice-and-comment rulemaking if the substance satisfies the CSA. DEA may designate a substance for control through notice-and-comment rulemaking if the substance satisfies the
applicable statutory criteria. The agency may also place a substance under temporary control on an emergency basis if theapplicable statutory criteria. The agency may also place a substance under temporary control on an emergency basis if the
substance poses an imminent hazard to public safety. In addition, DEA may designate a substance for control if required by substance poses an imminent hazard to public safety. In addition, DEA may designate a substance for control if required by
the United States’ international treaty obligations. In the alternative, Congress may place a substance under control by statute. the United States’ international treaty obligations. In the alternative, Congress may place a substance under control by statute.
The CSA simultaneously aims to ensure that patients have access to pharmaceutical controlled substances for legitimate The CSA simultaneously aims to ensure that patients have access to pharmaceutical controlled substances for legitimate
medical purposes while also seeking to protect public health from the dangers of controlled substances diverted into or medical purposes while also seeking to protect public health from the dangers of controlled substances diverted into or
produced for the illicit market. To accomplish those two goals, the statute creates two overlapping legal schemes. produced for the illicit market. To accomplish those two goals, the statute creates two overlapping legal schemes.
Registration provisions require entities working with controlled substances to register with DEA and take various steps to require entities working with controlled substances to register with DEA and take various steps to
prevent diversion and misuse of controlled substances. prevent diversion and misuse of controlled substances. Trafficking provisions establish penalties for the production, establish penalties for the production,
distribution, and possession of controlled substances outside the legitimate scope of the registration system. DEA is primarily distribution, and possession of controlled substances outside the legitimate scope of the registration system. DEA is primarily
responsible for enforcing the CSA’s registration provisions and works with the Criminal Division of the Department of responsible for enforcing the CSA’s registration provisions and works with the Criminal Division of the Department of
Justice to enforce the Act’s trafficking provisions. Violations of the registration provisions generally are not criminal Justice to enforce the Act’s trafficking provisions. Violations of the registration provisions generally are not criminal
offenses, but certain serious violations may result in criminal prosecutionsoffenses, but certain serious violations may result in criminal prosecutions, yielding fines fines, and even short prison sentences. Violations and even short prison sentences. Violations
of the trafficking provisions are criminal offenses that may result in large fines and lengthy prison sentences. of the trafficking provisions are criminal offenses that may result in large fines and lengthy prison sentences.
~~Drug regulation has received significant attention from Congress in recent years, with a number of bills introduced in the~~
~~116th Congress to amend the CSA in various ways. For example, the 116th Congress considered multiple proposals aimed at~~
~~addressing the opioid crisis, including the John S. McCain Opioid Addiction Prevention Act (H.R. 1614, S. 724), which~~
~~would have limited practitioners’ ability to prescribe opioids; the LABEL Opioids Act (H.R. 2732, S. 1449), which would~~
~~have required prescription opioids to bear certain warning labels; and the Ending the Fentanyl Crisis Act of 2019 (S. 1724),~~
~~which would have increased criminal liability for illicit trafficking in the powerful opioid fentanyl. The 116th Congress also~~
~~enacted the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act (P.L. 116-114),~~
~~which placed a broad class of fentanyl analogues in Schedule I on a temporary basis , and considered other measures~~
~~specifically seeking to address the proliferation of synthetic drugs that mimic the effects of fentanyl. In addition, multiple~~
~~recent proposals sought to address~~During the 117th Congress, significant legal developments related to controlled substances regulation occurred via executive branch actions, court decisions, and enacted federal and state legislation. Members of Congress also introduced a number of proposals to amend the CSA in various ways. For instance, the 117th Congress confronted ongoing issues related to the opioid epidemic, including the regulation of the powerful opioid fentanyl and its analogues and the legality of supervised consumption sites. Recent years also saw developments in marijuana law and policy, including a 2022 presidential grant of clemency for federal and D.C. marijuana possession offenses and a growing divergence between federal and state marijuana laws. Members of the 117th Congress reintroduced legislation such as the MORE Act (H.R. 3617) and introduced the Cannabis Administration and Opportunity Act (S. 4591), both of which would have removed marijuana from control under the CSA. Members also introduced other bills that would have addressed specific aspects of the divergence between federal the divergence between federal and state marijuana law, including proposals seeking~~and state marijuana laws . The MORE Act of 2019 (H.R.~~
~~3884, S. 2227), which passed the House in December 2020, would have removed marijuana from the schedules of controlled~~
~~substances. Other recent legislative proposals sought~~ to facilitate clinical research involving marijuana and other Schedule I to facilitate clinical research involving marijuana and other Schedule I
controlled substancescontrolled substances~~. In addition, the emergence of the Coronavirus Disease 2019 (COVID-19) pandemic in 2020 raised~~
~~legal issues under the CSA, including questions around the availability of controlled substances used in treating COVID-19~~
~~and medical practitioners’ ability to prescribe controlled substances via telemedicine. The various proposals introduced in the~~
~~116th Congress raise a number of legal questions that Congress may contemplate when deciding whether to change the laws~~
~~governing controlled substances~~, expand medical practitioners’ ability to prescribe controlled substances via telemedicine, and address sentencing disparities between CSA offenses involving crack and powder cocaine. .
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~~rescription~~harmaceutical drugs play a vital role in American public health. drugs play a vital role in American public health. ~~The~~Surveys by the Centers for Disease Centers for Disease
Control and Prevention (CDC) Control and Prevention (CDC) ~~estimates that during 2015 and 2016 over 45~~between 2015 and 2018 estimated that over 48% of % of
Americans had used one or more prescription drugs in the last 30 days.1 But Americans had used one or more prescription drugs in the last 30 days.1 But ~~unfettered~~
~~P access to drugs may~~ both P pharmaceutical and non-pharmaceutical drugs may also pose serious public health risks. pose serious public health risks. The CDC reports that 106,699 Americans died of drug overdoses in 2021~~The CDC reports that in 2018 over~~
~~67,000 Americans died of overdoses of prescription and nonprescription drugs~~.2 The .2 The
Controlled Substances Act3 (CSA or the Act) seeks to balance those competing considerations.4 Controlled Substances Act3 (CSA or the Act) seeks to balance those competing considerations.4
The CSA regulates The CSA regulates controlled substances——~~prescription and nonprescription~~pharmaceutical and non-pharmaceutical drugs and other drugs and other
substances that are deemed to pose a risk of abuse and dependence.5 By establishing rules for the substances that are deemed to pose a risk of abuse and dependence.5 By establishing rules for the
proper handling of controlled substances6 and imposing penalties for any proper handling of controlled substances6 and imposing penalties for any ~~il icit~~ illicit production, production,
distribution, or possession of such substances,7 the Act seeks to protect the public distribution, or possession of such substances,7 the Act seeks to protect the public ~~health~~ from the from the
dangers of controlled substances while also ensuring that patients have access to pharmaceutical dangers of controlled substances while also ensuring that patients have access to pharmaceutical
controlled substances for legitimate medical purposes.8 controlled substances for legitimate medical purposes.8
This report provides an overview of the CSA and select legal issues that have arisen under the This report provides an overview of the CSA and select legal issues that have arisen under the
Act, with a focus on legal issues Act, with a focus on legal issues ~~of concern for the 117th~~that may be relevant to the 118th Congress. The report first summarizes Congress. The report first summarizes
the history of the CSA and explains how the regulation of the history of the CSA and explains how the regulation of ~~drugs~~ controlled substances under the CSA overlaps with under the CSA overlaps with
other federal and state regulatory regimes.9 It then outlines the five main categories of substances other federal and state regulatory regimes.9 It then outlines the five main categories of substances
subject to the Act—known as subject to the Act—known as schedules—and discusses how substances are added to the —and discusses how substances are added to the
schedules.10 The report next outlines the CSA’s schedules.10 The report next outlines the CSA’s registration requirements, which govern the , which govern the
activities of individualsactivities of individuals and entities that register with the government to receive authorization to and entities that register with the government to receive authorization to
handle pharmaceutical controlled substances,11 before summarizing the CSA’s criminalhandle pharmaceutical controlled substances,11 before summarizing the CSA’s criminal
trafficking provisions, which apply to controlled-substance-related activities that are not , which apply to controlled-substance-related activities that are not
authorized under the Act.12 authorized under the Act.12 ~~Final y~~Finally, the report outlines select legal , the report outlines select legal ~~issues~~considerations for Congress related to for Congress related to
the CSA, including issues related to the response to the the CSA, including issues related to the response to the ~~opioid crisis, the control of analogues to~~
~~the potent~~ opioid opioid ~~fentanyl~~epidemic, the growing divergence between the , the growing divergence between the ~~treatment~~status of marijuana under of marijuana under
federal and state law, federal and state law, ~~the~~ legal limits on legal limits on clinical research and medical use of certain controlled substances, CSA 1 See CDC, Therapeutic Drug Use, https://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm (last visited Dec. 28, 2022). 2 See Merianne Rose Spencer, et al., Drug Overdose Deaths in the United States, 2001-2021, NCHS DATA BRIEF No. 457 (Dec. 2022). 3 21 U.S.C. §§ 801-904. 4 See id. §§ 801(1), (2). 5 See id. §§ 802(6), 811. The CSA adopts the definition of “drug” used in the Federal Food, Drug and Cosmetic Act. See 21 U.S.C. § 802(12); id. § 321(g)(1) (“The term ‘drug’ means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).”). The CSA does not apply exclusively to “drugs,” providing more broadly for the control of any “drug or other substance” included in the CSA’s schedules. 21 U.S.C. § 802(6). Substances subject to the CSA may include plants, such as marijuana or peyote, or chemicals not generally recognized as drugs. However, for the sake of simplicity, this report at times refers to “drugs” subject to the Act. 6 See id. §§ 821-832. 7 See id. §§ 841-865. 8 See id. §§ 801(1), (2). 9 See infra “Background and Scope of the CSA” and “~~medical use of certain controlled substances, and the~~
~~effects of the COVID-19 pandemic on control ed substance regulation.13~~
~~Background and Scope of the CSA~~
~~Congress has regulated drugs in some capacity since the 19th century. Federal drug regulation~~
~~began with tariffs, import and export controls, and purity and labeling requirements applicable to~~

~~1 See Crescent B. Martin, et al., Prescription Drug Use in the United States, 2015–2016, NCHS DATA BRIEF No. 334~~
~~(May 2019).~~
~~2 See Holly Hedegaard, et al., Drug Overdose Deaths in the United States, 1999–2018, NCHS DATA BRIEF No. 356~~
~~(Jan. 2020).~~
~~3 21 U.S.C. §§ 801-904. Unless otherwise indicated, this report uses United States Code citations for statutory material.~~
~~4 See id. §§ 801(1), (2).~~
~~5 See id. §§ 802(6), 811.~~
~~6 See id. §§ 821-832.~~
~~7 See id. §§ 841-865.~~
~~8 See id. §§ 801(1), (2).~~
~~9 See infra “Background and Scope of the CSA” and~~ “ Other Regulatory Schemes.”
10 10 See infra “Classification of Controlled Substances.”
11 11 See infra “Registration Requirements.”” 12 See infra “Trafficking Provisions.
~~12 See infra “T rafficking Provisions.”~~
~~13 See infra “Legal Considerations for the 117th Congress~~.” ”
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118th Congress regulation of prescribing controlled substances via telemedicine, and criminal sentences for CSA offenses involving crack cocaine.13 Background and Scope of the CSA Congress has regulated drugs in some capacity since the 19th century. Federal drug regulation began with tariffs, import and export controls, and purity and labeling requirements applicable to narcotic drugs such as opium and coca leaves and their derivatives.14 With the passage of the narcotic drugs such as opium and coca leaves and their derivatives.14 With the passage of the
Harrison Narcotics Tax Act of 1914, Congress began in earnest to regulate the domestic trade in Harrison Narcotics Tax Act of 1914, Congress began in earnest to regulate the domestic trade in
narcotic drugs.15 The Harrison Act imposed federal oversight of the legal trade in narcotic drugs narcotic drugs.15 The Harrison Act imposed federal oversight of the legal trade in narcotic drugs
and imposed criminal penalties for and imposed criminal penalties for ~~il icit~~ illicit trafficking in narcotics.16 Over the course of the 20th trafficking in narcotics.16 Over the course of the 20th
century, the list of drugs subject to federal control expanded beyond narcotic drugs to include century, the list of drugs subject to federal control expanded beyond narcotic drugs to include
marijuana, depressants, stimulants, and marijuana, depressants, stimulants, and ~~hal ucinogens~~hallucinogens.17 .17
In 1970, Congress revamped federal drug regulation by enacting the Comprehensive Drug Abuse In 1970, Congress revamped federal drug regulation by enacting the Comprehensive Drug Abuse
Prevention and Control Act.18 That act repealed nearly Prevention and Control Act.18 That act repealed nearly al all existing federal substance control laws existing federal substance control laws
and, for the first time, imposed a unified framework of federal controlled substance regulation.19 and, for the first time, imposed a unified framework of federal controlled substance regulation.19
Title II of the Comprehensive Drug Abuse Prevention and Control Act is known as the Controlled Title II of the Comprehensive Drug Abuse Prevention and Control Act is known as the Controlled
Substances Act.20 Substances Act.20
The CSA regulates certain The CSA regulates certain ~~drugs21~~drugs and other substances—whether medical or recreational, —whether medical or recreational, ~~legal y or il icitly~~
legally or illicitly distributed—that are found to pose a risk of abuse and dependence.distributed—that are found to pose a risk of abuse and dependence.2221 In enacting the CSA, In enacting the CSA,
Congress recognized two competing interests related to drug regulation. On one hand, many Congress recognized two competing interests related to drug regulation. On one hand, many
drugs “have a useful and legitimatedrugs “have a useful and legitimate medical purpose and are necessary to maintain the health and medical purpose and are necessary to maintain the health and
general welfare of the American people.”general welfare of the American people.”2322 On the other hand, “ On the other hand, “~~il egal~~ illegal importation, manufacture, importation, manufacture,
distribution, and possession and improper use of controlled substances have a substantial and distribution, and possession and improper use of controlled substances have a substantial and
detrimental effect on the health and general welfare of the American people.”detrimental effect on the health and general welfare of the American people.”24 23 Accordingly, the Accordingly, the
Act simultaneously aims to protect Act simultaneously aims to protect ~~public health~~the public from the dangers of controlled substances while from the dangers of controlled substances while
~~also~~ ensuring access to controlled substances for legitimate purposes.ensuring access to controlled substances for legitimate purposes.
To accomplish those two goals, the statute To accomplish those two goals, the statute ~~creates~~imposes two overlapping legal schemes. two overlapping legal schemes. Registration
provisions require individuals and entities working with controlled substances to register with the require individuals and entities working with controlled substances to register with the
government, take steps to prevent diversion and misuse of controlled substances, and report government, take steps to prevent diversion and misuse of controlled substances, and report
certain information to regulators.certain information to regulators.2524 Trafficking provisions establish penalties for the production, establish penalties for the production,
~~distribution, and possession of controlled substances outside the legitimate scope of the~~
~~registration system.26~~

~~14 T homas M. Quinn & Gerald T~~ 13 See infra “Legal Considerations for the 118th Congress.” 14 Thomas M. Quinn & Gerald T. McLaughlin, . McLaughlin, The Evolution of Federal Drug Control Legislation, 22 CATH. U.L. , 22 CATH. U.L.
REV. 586, 589-93 (1973). REV. 586, 589-93 (1973).
15 Pub. L. No. 63-223, 38 Stat. 785 (1915). 15 Pub. L. No. 63-223, 38 Stat. 785 (1915).
16 S16 See Quinn & McLaughlin,Quinn & McLaughlin, supra ~~note 14~~ note 14 at 593. at 593.
17 17 Id. at 600-03. at 600-03.
18 Pub. L. No. 91-513, 84 Stat. 1236 (1970). Congress has the authority to regulate controlled substances under the 18 Pub. L. No. 91-513, 84 Stat. 1236 (1970). Congress has the authority to regulate controlled substances under the
Commerce Clause.Commerce Clause. See Gonzales Gonzales v. Raich, 545 U.S. 1, 15 (2004). v. Raich, 545 U.S. 1, 15 (2004).
19 Quinn & McLaughlin, 19 Quinn & McLaughlin, supra notnote 14 at 605. at 605.
20 20 ~~T itle~~Title III of the Comprehensive Drug Abuse III of the Comprehensive Drug Abuse Prevention and Control Act is the closely related Controlled Substances Prevention and Control Act is the closely related Controlled Substances
Import and Export Act. Import and Export Act. See 21 U.S.C. §§ 21 U.S.C. §§ 951-971. 951-971.
21 See 21 U.S.C. §§ 811, 812. 22 Id. § 801(1). 23 Id. § 801(2). 24 See id. §§ 821-832. Congressional Research Service 2 link to page 21 link to page 8 link to page 10 link to page 12 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress distribution, and possession of controlled substances outside the legitimate scope of the registration system.25 The CSA does not apply to all drugs. As discussed below, substances must generally be identified for control (either individually or as a class) to fall within the scope of the Act.26 For medical drugs, the CSA primarily ~~21 T he CSA does not apply exclusively to “drugs,” providing more broadly for the control of any “drug or other~~
~~substance” included in the CSA’s schedules. 21 U.S.C. § 802(6). Subst ances subject to the CSA may include plants,~~
~~such as marijuana or peyote, or chemicals not generally recognized as drugs. However, for the sake of simplicity, this~~
~~report refers to “drugs” subject to the Act.~~
~~22 See 21 U.S.C. §§ 811, 812.~~
~~23 Id. § 801(1).~~
~~24 Id. § 801(2).~~
~~25 See id. §§ 821-832.~~
~~26 Id. §§ 841-865.~~
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~~The CSA does not apply to al drugs. As discussed below, substances must be specifical y~~
~~identified for control (either individual y or as a class) to fal within the scope of the Act.27 For~~
~~medical drugs, the CSA primarily~~ applies to prescription drugs, not drugs available over the applies to prescription drugs, not drugs available over the
counter.counter.28 27 Moreover, the statute does not apply to Moreover, the statute does not apply to al all prescription drugsprescription drugs, but rather to a subset of but rather to a subset of
those drugs deemed to warrant additional controls.those drugs deemed to warrant additional controls.~~29 As for nonpharmaceutical drugs, wel~~ 28 As for non-pharmaceutical drugs, well-known -known
recreational drugs such as marijuana, cocaine,recreational drugs such as marijuana, cocaine,3029 heroin, and lysergic acid diethylamide (LSD) are heroin, and lysergic acid diethylamide (LSD) are
al all controlled substances, as are numerous lesser-known substances, some of which are identified controlled substances, as are numerous lesser-known substances, some of which are identified
only by their chemical formulas.only by their chemical formulas.3130 Some recreational drugs are not classified as Some recreational drugs are not classified as ~~federal y~~federally
controlled substances.controlled substances.3231 Alcohol and tobacco, which might otherwise qualify as drugs Alcohol and tobacco, which might otherwise qualify as drugs ~~potential y~~potentially
warranting control under the CSA, are explicitlywarranting control under the CSA, are explicitly excluded from the scope of the Act,excluded from the scope of the Act,3332 as is hemp as is hemp
that meets certain statutory requirements.that meets certain statutory requirements.~~34 Final y~~33 Finally, it is possible for legitimate researchers and , it is possible for legitimate researchers and
~~il icit~~ illicit drug manufacturers to formulate new drugs not listed in any of the Act’s schedules. Even if drug manufacturers to formulate new drugs not listed in any of the Act’s schedules. Even if
those drugs are similar to existing controlled substances, they may those drugs are similar to existing controlled substances, they may ~~fal~~ fall outside the scope of the outside the scope of the
CSA unless they are classified as controlled substances.CSA unless they are classified as controlled substances.35
~~Other Regulatory Schemes~~
~~Many drugs classified as controlled substances subject to the CSA are also subject to other legal~~
~~regimes. For example, al pharmaceutical drugs, including those subject to the Act, are subject to~~
~~the Federal Food, Drug, and Cosmetic Act (FD&C Act).36~~34 In some cases, however, substances not specifically listed in the CSA’s schedules may nonetheless be subject to CSA regulation as controlled substance analogues.35 25 Id. §§ 841-865. 26 Id. § 811. 27 Id. § 829; see also infra “Prescriptions.” The U.S. Food and Drug The U.S. Food and Drug
~~Administration (FDA) is the agency primarily responsible for enforcing the FD&C Act which,~~
~~among other things, prohibits the “introduction or delivery for introduction into interstate~~
~~commerce of any . . . drug . . . that is adulterated or misbranded.”37 The FD&C Act defines~~
~~misbranding broadly: a drug is considered misbranded if, among other things, its labeling,~~

~~27 Id. § 811.~~
~~28 Id. § 829; see also infra “Prescriptions.”~~
~~29 T he~~Administration also regulates pharmaceutical drugs, including pharmaceutical controlled substances, under the Federal Food, Drug, and Cosmetic Act. See infra “Federal Food, Drug, and Cosmetic Act.” 28 The Drug Enforcement Administration (DEA) has estimated that 10%-11% of all drug Drug Enforcement Administration (DEA) has estimated that 10%-11% of all drug prescriptions written in the prescriptions written in the
United States are for controlled substances. United States are for controlled substances. See DEA, Dispensing of Controlled Substances DEA, Dispensing of Controlled Substances to Residents at Long to Residents at Long ~~T erm~~Term
Care Facilities, 75 Fed. Reg.Care Facilities, 75 Fed. Reg. 37,463, 37,464 (June 29, 2010). 37,463, 37,464 (June 29, 2010).
30 29 Although cocaine is Although cocaine is commonly considered a commonly considered a ~~nonpharmaceutical~~non-pharmaceutical drug, it has been placed drug, it has been placed in Schedulein Schedule II, reflecting a II, reflecting a
finding that it has an accepted medicalfinding that it has an accepted medical use. use. See 21 C.F.R. § 21 C.F.R. § 1308.12(b)(4); 1308.12(b)(4); see also infra “ Overview of Schedules.”
~~31 T he~~30 The full schedules full schedules are promulgated at 21 C.F.R.are promulgated at 21 C.F.R. §§ §§ 1308.11-1308.15. 1308.11-1308.15.
3231 For example, Salvia For example, Salvia divinorum (an herb with hallucinogenic effects) and kratom (a tropical tree whose leaves may divinorum (an herb with hallucinogenic effects) and kratom (a tropical tree whose leaves may
have either stimulant or sedative effects depending on dosage) are not subject to the CSAhave either stimulant or sedative effects depending on dosage) are not subject to the CSA at this writing, although DEA at this writing, although DEA
has identified them as “has identified them as “drugs ~~drugs~~ of concern.” DEA, DRUGS OF ABUSE: A DEA RESOURCE GUIDE, 84-85 (2017). of concern.” DEA, DRUGS OF ABUSE: A DEA RESOURCE GUIDE, 84-85 (2017).
3332 See 21 U.S.C. 21 U.S.C. § § 802(6). 802(6).
3433 Id. § 802(16)(B)(i). Hemp and marijuana are both varieties of the cannabis plant. Hemp is defined § 802(16)(B)(i). Hemp and marijuana are both varieties of the cannabis plant. Hemp is defined as “as “ the plant the plant
CannabisCannabis sativa L. and any part of that plantsativa L. and any part of that plant ~~. .~~ ... with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 . with a delta-9 tetrahydrocannabinol concentration of not more than 0.3
percent on a dry weight basis.”percent on a dry weight basis.” 7 U.S.C.7 U.S.C. § 1639(o). § 1639(o). ~~T he~~The cannabis plant and most products produced from that plant cannabis plant and most products produced from that plant
remain controlled substances subjectremain controlled substances subject to the CSA,to the CSA, ~~unless~~ unless they meet the statutory definition of hemp. they meet the statutory definition of hemp. See 21 C.F.R. 21 C.F.R.
§ 1308.11(d)(23). § 1308.11(d)(23).
35 34 See ~~T he~~The Countdown: Fentanyl Analogues & the Expiring Emergency Scheduling Countdown: Fentanyl Analogues & the Expiring Emergency Scheduling Order: Hearing Before the Sen. Order: Hearing Before the Sen.
Comm. on the JudiciaryComm. on the Judiciary, , 116th Cong. 1, 4 (2019) (statement of the U.S. Dep’t of Justice) [hereinafter, DOJ 116th Cong. 1, 4 (2019) (statement of the U.S. Dep’t of Justice) [hereinafter, DOJ
~~T estimony];~~ Testimony]; see also CRSsee also CRS Report R42066, Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa, by Lisa N. SaccoN. Sacco ~~and~~
~~Kristin Finklea. In some cases, substances not specifically listed in the CSA’s schedules may qualify as controlled~~
~~substance analogues.~~ and Kristin Finklea. 35 See infra “ Analogues and Listed Chemicals.”
~~36 21 U.S.C. §§ 301-399i.~~
~~37 Id. § 331(a).~~
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~~advertising, or promotion “is false or misleading in any particular.”38 Unlabeled~~ Congressional Research Service 3 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress Other Regulatory Schemes Federal Food, Drug, and Cosmetic Act Many drugs classified as controlled substances subject to the CSA are also subject to other legal regimes. For example, all pharmaceutical drugs, including those subject to the Act, are subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act).36 The U.S. Food and Drug Administration (FDA) is the agency primarily responsible for enforcing the FD&C Act, which, among other things, prohibits the “introduction or delivery for introduction into interstate commerce of any ... drug ... that is adulterated or misbranded.”37 The FD&C Act defines misbranding broadly: a drug is considered misbranded if, among other things, its labeling, advertising, or promotion “is false or misleading in any particular.”38 Unlabeled drugs are drugs are
considered misbranded,39 as are prescription drugs that FDA has not approved, including considered misbranded,39 as are prescription drugs that FDA has not approved, including
imported drugs.40 The FD&C Act provides that a drug is deemed to be adulterated if, among other imported drugs.40 The FD&C Act provides that a drug is deemed to be adulterated if, among other
things, it “consists in whole or in part of any filthy, putrid, or decomposed substance,” “it has things, it “consists in whole or in part of any filthy, putrid, or decomposed substance,” “it has
been prepared, packed, or held under insanitary conditions,” its container is made of “any been prepared, packed, or held under insanitary conditions,” its container is made of “any
poisonous or deleterious substance,” or its strength, quality, or purity is not as represented.41poisonous or deleterious substance,” or its strength, quality, or purity is not as represented.41
The key aims of the FD&C Act are related to but distinct from those of the CSA. The CSA The key aims of the FD&C Act are related to but distinct from those of the CSA. The CSA
establishes distribution controls to prevent the misuse of substances deemed to pose a potential establishes distribution controls to prevent the misuse of substances deemed to pose a potential
danger to the public welfare.42 The FD&C Act, by contrast, is a consumer protection statute that danger to the public welfare.42 The FD&C Act, by contrast, is a consumer protection statute that
seeks to protect consumers from obtaining unsafe or ineffective drugs (and other public health seeks to protect consumers from obtaining unsafe or ineffective drugs (and other public health
products) through commercial channels.43 Any person or organization that produces, distributes, products) through commercial channels.43 Any person or organization that produces, distributes,
or otherwise works with prescription drugs that are also controlled substances must comply with or otherwise works with prescription drugs that are also controlled substances must comply with
the requirements of both the CSA and the FD&C Act. the requirements of both the CSA and the FD&C Act.
State Laws Addressing Controlled Substances With respect to both pharmaceutical and With respect to both pharmaceutical and ~~nonpharmaceutical~~non-pharmaceutical drugs, many drugs subject to the drugs, many drugs subject to the
CSA are also subject to state controlled substance laws.44 CSA are also subject to state controlled substance laws.44 ~~State substance control~~Such state laws often laws often
mirror federal lawmirror federal law ~~and~~, and they are relatively uniform across jurisdictions because almost are relatively uniform across jurisdictions because almost al all states have states have
adopted a version of a model statute adopted a version of a model statute ~~cal ed~~called the Uniform Controlled Substances Act (UCSA).45 the Uniform Controlled Substances Act (UCSA).45
~~However, states are free to modify the UCSA, and have done so to varying extents.46 Moreover,~~
~~the model statute does not specify sentences for violations, so penalties for state controlled~~
~~substance offenses vary widely.47~~
~~There is not a complete overlap between drugs subject to federal and state control for several~~
~~reasons. First, states may elect to impose controls on substances that are not subject to the CSA.48~~
~~For example, some states have controlled the fentanyl analogues benzylfentanyl and~~
~~thenylfentanyl, but those substances are not currently scheduled under the CSA.49 Second, states~~

However, 36 21 U.S.C. §§ 301-399i. 37 Id. § 331(a). 38 38 Id. § 352. § 352.
39 39 See United States v. Wood, 8 F.3d 33, 1993 WL 425948 ( United States v. Wood, 8 F.3d 33, 1993 WL 425948 (~~T able~~Table) at *3 (9th Cir. 1993). ) at *3 (9th Cir. 1993).
40 40 See, e.g., , In re Canadian Canadian Import Antitrust Litigation, 470 F.3d 785, 788Import Antitrust Litigation, 470 F.3d 785, 788 -90 (8th Cir. 2006); United States v. -90 (8th Cir. 2006); United States v.
Patwardhan, 422 Fed. App’x. 614, 616-17 (9th Cir. 2011). Misbranding also includesPatwardhan, 422 Fed. App’x. 614, 616-17 (9th Cir. 2011). Misbranding also includes misrepresenting that a substance misrepresenting that a substance
offered for saleoffered for sale is a brand-name drug.is a brand-name drug. See, e.g., United States v. Xin He, 405 Fed., United States v. Xin He, 405 Fed. App’x 220, 221 (9th Cir. 2010).App’x 220, 221 (9th Cir. 2010).
~~41 21 U.S.C. § 351.~~
42 See id. ~~§ 801(1) (“~~ The FD&C Act also contains a separate provision stating, “No person shall introduce or deliver for introduction into interstate commerce any new drug” unless the drug is approved under the FD&C Act. 21 U.S.C. § 355(a). 41 21 U.S.C. § 351. 42 See id. § 801(1) (“The illegal importation, manufacture, distribution, and possession and improper use of controlled The illegal importation, manufacture, distribution, and possession and improper use of controlled
substancessubstances have a substantial and detrimental effect on the health and general welfarehave a substantial and detrimental effect on the health and general welfare of the American people.”).of the American people.”).
43 43 See, e.g., United States v. Kordel, 397 U.S., United States v. Kordel, 397 U.S. 1, 11 (1970) (invoking the “1, 11 (1970) (invoking the “ public interest in protecting consumers public interest in protecting consumers
throughout the Nation from misbranded drugs”);throughout the Nation from misbranded drugs”); see also CRSCRS Report R43609, Report R43609, ~~Enforcem ent~~Enforcement of the Food, Drug, and
~~Cosm etic~~Cosmetic Act: Select Legal Issues, by, by Jennifer A. Staman. Jennifer A. Staman.
44 ALEX KREIT, CONTROLLED SUBSTANCES: CRIME, REGULATION, AND POLICY 628 (2013). 44 ALEX KREIT, CONTROLLED SUBSTANCES: CRIME, REGULATION, AND POLICY 628 (2013).
45 Richard L. Braun, 45 Richard L. Braun, Uniform Controlled Substances Act of 1990, 13 CAMPBELL L. REV. 365, 365 (1991) (, 13 CAMPBELL L. REV. 365, 365 (1991) (~~T he UCSA~~
~~“has been the basic law pertaining to control of narcotic drugs in forty-six (46) states.”).~~
~~46 For example, Arkansas has adopted the UCSA but added a sixth schedule for “ substances that are determined to be~~
~~inappropriately classified by placing them in Schedules I through V.” Ark. Code Ann. § 5-64-213. In addition, the~~
~~UCSA classifies marijuana as a Schedule I controlled substance subject to stringent controls; however, ma ny states~~
~~have passed laws decriminalizing some or all marijuana use. See infra “ Marijuana Policy Gap”; see also Kimberly A.~~
~~Houser,~~ ~~What Inconsistent Federal Policy Means for Marijuana Business Owners: Washington’ s I-502 and the Federal~~
~~Controlled Substances Act, 50 GONZ. L. REV. 305, 308-09 (2015).~~
~~47 Braun, Uniform Controlled Substances Act of 1990, 13 CAMPBELL L. REV. at 371; see also Kreit, supra note 44 at~~
~~628.~~
~~48 Kreit, supra note 44 at 628.~~
~~49 See, e.g., United States v. Guerrero, 910 F.3d 72, 75 (2d Cir. 2018) (discussing difference in scheduling between~~
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The UCSA Congressional Research Service 4 link to page 34 link to page 8 link to page 8 link to page 8 link to page 34 link to page 16 link to page 22 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress states are free to modify the UCSA, and have done so to varying extents.46 Moreover, the model statute does not specify sentences for violations, so penalties for state controlled substance offenses vary widely.47 There is not a complete overlap between drugs subject to federal and state controlled substance laws for several reasons. First, states may elect to impose controls on substances that are not subject to the CSA.48 For example, some states have controlled the fentanyl analogues benzylfentanyl and thenylfentanyl, but those substances are not currently scheduled under the CSA.49 Second, states may wish to adopt federal scheduling decisions at the state level but lag behind federal regulators may wish to adopt federal scheduling decisions at the state level but lag behind federal regulators
due to the need for a separate state scheduling process.50 Third, states may decide not to impose due to the need for a separate state scheduling process.50 Third, states may decide not to impose
state controls on substances subject to the CSA, or they may choose to impose modified versions state controls on substances subject to the CSA, or they may choose to impose modified versions
of federal controls at the state level.51 of federal controls at the state level.51
~~Crucial y~~Crucially, however, the states cannot alter federal law, and when state and federal law conflict, the , however, the states cannot alter federal law, and when state and federal law conflict, the
federal law controls.52 Thus, when states “legalize” or “decriminalize” a federal law controls.52 Thus, when states “legalize” or “decriminalize” a ~~federal y~~federally controlled controlled
substance (as many have done recently with respect to marijuana), the sole result is that the substance (as many have done recently with respect to marijuana), the sole result is that the
substance is no longer controlled substance is no longer controlled under state law.53 Any federal controls remain in effect and .53 Any federal controls remain in effect and
~~potential y~~potentially enforceable in those states.54 enforceable in those states.54
Classification of Controlled Substances
The heart of the CSA is its system for classifying controlled substances, as nearly The heart of the CSA is its system for classifying controlled substances, as nearly al all the the
obligations and penalties that the Act establishes flow from the classification system.55 Drugs obligations and penalties that the Act establishes flow from the classification system.55 Drugs
~~become subject to the CSA by being placed in one of five lists, referred to as “schedules.”56 Both~~
~~the Administrator of the Drug Enforcement Administration (DEA)—an arm of the Department of~~
~~Justice (DOJ)—and Congress can place a substance in a schedule, move a controlled substance to~~
~~a different schedule, or remove a controlled substance from a schedule.57 As discussed below,~~
~~scheduling decisions by Congress and DEA follow different procedures.58~~
~~Overview of Schedules~~
~~The CSA establishes five categories of controlled substances, referred to as Schedules I through~~
~~V.59 The schedule on which a controlled substance is placed determines the level of restriction~~
~~imposed on its production, distribution, and possession, as wel as the penalties applicable to any~~
~~improper handling of the substance.60 As Figure 1 describes, when DEA places substances under~~

~~federal law and Arizona law); McCoy v. United States, 707 F.3d 184 (2d Cir. 2013) (same with respect to Connecticut~~
~~law).~~ “has been the basic law pertaining to control of narcotic drugs in forty-six (46) states.”). 46 For example, Arkansas has adopted the UCSA but added a sixth schedule for “substances that are determined to be inappropriately classified by placing them in Schedules I through V.” Ark. Code Ann. § 5-64-213. In addition, the UCSA classifies marijuana as a Schedule I controlled substance subject to stringent controls; however, many states have passed laws decriminalizing some or all marijuana use. See infra “Federal and State Marijuana Regulation”; see also Kimberly A. Houser, What Inconsistent Federal Policy Means for Marijuana Business Owners: Washington’s I-502 and the Federal Controlled Substances Act, 50 GONZ. L. REV. 305, 308-09 (2015). 47 Braun, Uniform Controlled Substances Act of 1990, 13 CAMPBELL L. REV. at 371; see also Kreit, supra note 44 at 628. 48 Kreit, supra note 44 at 628. 49 See, e.g., United States v. Guerrero, 910 F.3d 72, 75 (2d Cir. 2018) (discussing difference in scheduling between federal law and Arizona law); McCoy v. United States, 707 F.3d 184 (2d Cir. 2013) (same with respect to Connecticut law). Benzylfentanyl and thenylfentanyl were temporarily placed under federal control in 1985, but the temporary Benzylfentanyl and thenylfentanyl were temporarily placed under federal control in 1985, but the temporary
schedulingscheduling expired in 1986, and DEA has determined that the substances are “essentially inactive, with no evidence of expired in 1986, and DEA has determined that the substances are “essentially inactive, with no evidence of
abuseabuse potential.” DEA, Correction of Code of Federalpotential.” DEA, Correction of Code of Federal ~~Regulat ions~~ Regulations: Removal of : Removal of ~~T emporary~~Temporary Listing of Benzylfentanyl Listing of Benzylfentanyl
and and ~~T henylfentanyl~~Thenylfentanyl as Controlled Substances, 75 Fed. as Controlled Substances, 75 Fed. Reg.Reg. 37,300, 37,300 (June 29, 2010). 37,300, 37,300 (June 29, 2010).
50 Kreit, 50 Kreit, supra ~~not~~enote 44 at 629. at 629.
51 51 Id. at 628 (citing Ruiz-Vidal. at 628 (citing Ruiz-Vidal v. Gonzales, 473 F.3d 1072, 1078 (9th Cir. 2007)). v. Gonzales, 473 F.3d 1072, 1078 (9th Cir. 2007)).
52 U.S. CONST. art. VI, cl. 2 (“52 U.S. CONST. art. VI, cl. 2 (“ the laws of the United States .the laws of the United States . . .. shall be the supreme law. shall be the supreme law of the land; and the judgesof the land; and the judges in in
every state shall beevery state shall be ~~bound~~ bound thereby, anything in the Constitution or laws of any State to the contrary notwithstanding”). thereby, anything in the Constitution or laws of any State to the contrary notwithstanding”).
53 53 See Gonzales Gonzales v. Raich, 545 U.S.v. Raich, 545 U.S. 1, 29 (2005). 1, 29 (2005).
54 DEA and DOJ sometimes do not enforce federal controlled substances law54 DEA and DOJ sometimes do not enforce federal controlled substances law with respect to state-legal activities that with respect to state-legal activities that
violate the CSA. Reasonsviolate the CSA. Reasons for this includefor this include the exercise the exercise of prosecutorial discretion and the existence of appropriations riders prosecutorial discretion and the existence of appropriations riders
limiting enforcement of the CSA in some circumstances. For further discussionlimiting enforcement of the CSA in some circumstances. For further discussion of the relationship between state of the relationship between state
legalization of controlled substanceslegalization of controlled substances and the CSA,and the CSA, see the see the “ ~~Marijuana Policy Gap~~Federal and State Marijuana Regulation” section. section.
55 For further discussion 55 For further discussion of the obligations and penalties that the Act imposes, see theof the obligations and penalties that the Act imposes, see the “ “Registration Requirements~~” and~~
~~“T rafficking Provisions” sections.~~
~~56 21 U.S.C. § 812.~~
~~57 See infra “Scheduling Procedures.”~~
58 See id.
~~59 21 U.S.C. § 812.~~
60 See, e.g.~~, 21 U.S.C. §~~ ” and “Trafficking Provisions” sections. Congressional Research Service 5 link to page 11 link to page 13 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress become subject to the CSA by being placed in one of five lists, referred to as schedules.56 Either the administrator of the Drug Enforcement Administration (DEA)—an agency within the Department of Justice (DOJ)—or Congress can place a substance in a schedule, move a controlled substance to a different schedule, or remove a controlled substance from a schedule.57 As discussed below, scheduling decisions by Congress and DEA follow different procedures.58 Overview of Schedules The CSA establishes five categories of controlled substances, referred to as Schedules I through V.59 The schedule on which a controlled substance is placed determines the level of restriction imposed on its production, distribution, and possession, as well as the penalties applicable to any improper handling of the substance.60 As Figure 1 describes, when DEA places substances under control by regulation, the agency assigns each controlled substance to a schedule based on its medical utility and its potential for abuse and dependence. 56 21 U.S.C. § 812. 57 See infra “Scheduling Procedures.” 58 See id. 59 21 U.S.C. § 812. 60 See, e.g., 21 U.S.C. § 823 (registration requirements); 823 (registration requirements); id. § 829 (prescription requirements); § 829 (prescription requirements); id. §§ 841-842 §§ 841-842
(prohibitions and penalties). (prohibitions and penalties).
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The Controlled Substances Act (CSA): A Legal Overview for the ~~117th Congress~~

~~control by regulation, the agency assigns each controlled substance to a schedule based on its~~
~~medical utility and its potential for abuse and dependence.~~
118th Congress Figure 1. CSA Scheduling Criteria

Notes:
11 21 U.S.C.21 U.S.C. § 812(b)(1). § 812(b)(1).
2 The CSA 2 The CSA ~~general y~~generally uses the word “marihuana” to refer uses the word “marihuana” to refer to the cannabis plant and its derivatives.to the cannabis plant and its derivatives. This report This report
uses the moreuses the more widely accepted widely accepted ~~spel ing,~~ spelling, “marijuana,”“marijuana,” unless quoting other sources. unless quoting other sources.
3 For the ful list of substances in Schedule I, see 21 C.F.R.3 For the ful list of substances in Schedule I, see 21 C.F.R. § 1308.11. § 1308.11.
4 21 U.S.C.4 21 U.S.C. § 812(b)(2). § 812(b)(2).
5 The CSA distinguishes between 5 The CSA distinguishes between ~~prescription fentanyl and il icit fentanyl. Prescription fentanyl~~fentanyl and non-pharmaceutical fentanyl analogues. Fentanyl and several and several
related medicationsrelated medications are in Schedule II. Numerousare in Schedule II. Numerous nonprescription fentanylnonprescription fentanyl ~~analogues~~-related compounds are in Schedule I. are in Schedule I.
6 For the ful list of substances in Schedule II, see6 For the ful list of substances in Schedule II, see 21 C.F.R. § 1308.12. 21 C.F.R. § 1308.12.
7 21 U.S.C.7 21 U.S.C. § 812(b)(3). § 812(b)(3).
8 For the ful list of substances in Schedule III, see 21 C.F.R. § 1308.13. 8 For the ful list of substances in Schedule III, see 21 C.F.R. § 1308.13.
9 21 U.S.C.9 21 U.S.C. § 812(b)(4). § 812(b)(4).
10 For the ful list of substances in Schedule IV, see 21 C.F.R. § 1308.14 10 For the ful list of substances in Schedule IV, see 21 C.F.R. § 1308.14
11 21 U.S.C.11 21 U.S.C. § 812(b)(5). § 812(b)(5).
12 For the ful list of substances in Schedule V, see 21 C.F.R. § 1308.15. 12 For the ful list of substances in Schedule V, see 21 C.F.R. § 1308.15.
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A lower schedule number corresponds to greater restrictions, so controlled substances in Schedule A lower schedule number corresponds to greater restrictions, so controlled substances in Schedule
I are subject to the most stringent controls, while substances in Schedule V are subject to the least I are subject to the most stringent controls, while substances in Schedule V are subject to the least
stringent.61 Notably, because substances in Schedule I have no accepted medical use, it is only stringent.61 Notably, because substances in Schedule I have no accepted medical use, it is only
legal to produce, dispense, and possess those substances in the context of legal to produce, dispense, and possess those substances in the context of ~~federal y~~federally approved approved
scientific studies.62 scientific studies.62
Analogues and Listed Chemicals
In addition to the controlled substances listed in Schedules I through V, the CSA also regulates In addition to the controlled substances listed in Schedules I through V, the CSA also regulates
(1) (1) controlled substance analogues and (2) and (2) listed chemicals. .
Under the CSA, a controlled substance analogue is a substance that FDA has not approved and Under the CSA, a controlled substance analogue is a substance that FDA has not approved and
that is not that is not ~~specifical y~~specifically scheduled under the Act, but that has (1) a chemical structure scheduled under the Act, but that has (1) a chemical structure ~~substantial y~~
substantially similar to that of a controlled substance in Schedule I or IIsimilar to that of a controlled substance in Schedule I or II, or (2) an actual or intended effect that or (2) an actual or intended effect that
is “is “~~substantial y~~substantially similar to or greater than the stimulant, depressant, or similar to or greater than the stimulant, depressant, or ~~hal ucinogenic~~hallucinogenic effect on effect on
the central nervous system of a controlled substance in schedule I or II.”63 A substance that meets the central nervous system of a controlled substance in schedule I or II.”63 A substance that meets
those criteria those criteria and is intended for human consumption is treated as a controlled substance in is intended for human consumption is treated as a controlled substance in
Schedule I.64 It may seem counterintuitive that an analogue to a Schedule II controlled substance Schedule I.64 It may seem counterintuitive that an analogue to a Schedule II controlled substance
is treated as if it were a Schedule I controlled substance and thus is subject to more stringent is treated as if it were a Schedule I controlled substance and thus is subject to more stringent
controls than the substance it mimics. However, substances in Schedules I and II may have a controls than the substance it mimics. However, substances in Schedules I and II may have a
similarly high potential for abuse. The key difference between those schedules is that Schedule II similarly high potential for abuse. The key difference between those schedules is that Schedule II
controlled substances have an accepted medical use, which controlled substance analogues do not controlled substances have an accepted medical use, which controlled substance analogues do not
~~have~~have because they have not been approved by FDA. .
Listed chemicals subject to the CSA are precursor chemicals that are Listed chemicals subject to the CSA are precursor chemicals that are ~~general y~~generally not intended for not intended for
human consumption but can be used to produce controlled substances.65 They may be placed on human consumption but can be used to produce controlled substances.65 They may be placed on
~~one of two lists:~~

~~61 See John Doe, Inc. v. DEA, 484 F.3d 561, 563 (D.C. Cir. 2007) (“ Schedule I is the most stringently controlled, and~~
~~schedule V the least .”).~~
~~62 See 21 U.S.C. § 823(f); see also Gonzales v. Raich, 545 U.S. 1, 14 (2004). Perhaps counterintuitively, marijuana and~~
~~marijuana extract are in Schedule I, see 21 C.F.R. §§ 1308.11(23), 1308.11(58), but FDA-approved drugs containing~~
~~the marijuana extract cannabidiol (CBD) are in Schedule V, see id. § 1308.15(f). As of July 2019, FDA has approved~~
~~one drug containing CBD, a seizure medication called Epidiolex. See Press Release, FDA, FDA Approves First Drug~~
~~Comprised of an Active Ingredient Derived from Marijuana to T reat Rare, Severe Forms of Epilepsy (June 26, 2018),~~
~~https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient -derived-~~
~~marijuana-treat -rare-severe-forms; see also CRS In Focus IF11250,~~ ~~FDA Regulation of Cannabidiol (CBD) Consum er~~
~~Products, by Agata Bodie and Renée Johnson.~~
one of two lists:  List I Chemicals—designated chemicals that, in addition to legitimate uses, are used in manufacturing a controlled substance in violation of the CSA and are important to the manufacture of a controlled substance.66  List II Chemicals—designated chemicals that, in addition to legitimate uses, are used in manufacturing a controlled substance in violation of the CSA.67 List I chemicals include substances such as ephedrine, white phosphorous, and iodine, which are used to produce methamphetamine, as well as chemicals used to manufacture LSD, MDMA (also 61 See John Doe, Inc. v. DEA, 484 F.3d 561, 563 (D.C. Cir. 2007). 62 See 21 U.S.C. § 823(f); see also Gonzales v. Raich, 545 U.S. 1, 14 (2004). 63 63 Id. § 802(32). § 802(32).
64 64 Id. § 813(a). § 813(a).
65 65 See United States v. Hofstatter, 8 F.3d 316, 321-22 (6th Cir. 1993) (in upholding convictions for possession of listed United States v. Hofstatter, 8 F.3d 316, 321-22 (6th Cir. 1993) (in upholding convictions for possession of listed
chemicals with intent to manufacture controlled substance analogues, consideringchemicals with intent to manufacture controlled substance analogues, considering evidence that “evidence that “ the defendants were the defendants were
attempting to manufacture substances designedattempting to manufacture substances designed for human consumption and designedfor human consumption and designed to produce amphetamine-like to produce amphetamine-like
effects when effects when ~~ingest ed~~ingested”). It is, however, possible”). It is, however, possible for a substancefor a substance to be both a listed chemical and a controlled substance to be both a listed chemical and a controlled substance
analogue. analogue. See 21 U.S.C. 21 U.S.C. § 802(32)(B) (“§ 802(32)(B) (“ The designation of gamma butyrolactone or any other chemical as a listed The designation of gamma butyrolactone or any other chemical as a listed
chemical pursuant to paragraph (34) or (35) does not preclude a finding pursuant to subparagraph (A) of this paragraph chemical pursuant to paragraph (34) or (35) does not preclude a finding pursuant to subparagraph (A) of this paragraph
that the chemical is a controlled substance analogue.”); that the chemical is a controlled substance analogue.”); see also United States v. Fisher, 289 F.3d 1329, 1335 United States v. Fisher, 289 F.3d 1329, 1335 -36 (11th -36 (11th
Cir. 2002) (finding that a listed chemical couldCir. 2002) (finding that a listed chemical could be treated as a controlled substance analogue if intended for human be treated as a controlled substance analogue if intended for human
consumption). consumption).
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~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~ List I Chemicals—designated chemicals that, in addition to legitimate uses, are~~
~~used in manufacturing a controlled substance in violation of the CSA and are~~
~~important to the manufacture of a controlled substance.66~~
~~ List II Chemicals—designated chemicals that, in addition to legitimate uses, are~~
~~used in manufacturing a controlled substance in violation of the CSA.67~~
~~List I chemicals include substances such as ephedrine, white phosphorous, and iodine, which are~~
~~used to produce methamphetamine, as wel as chemicals used to manufacture LSD, MDMA (also~~66 21 C.F.R. § 1300.02(b18). 67 Id. § 1300.02(b19). Congressional Research Service 8 link to page 27 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress
known as “ecstasy” or “molly”), and other drugs.68 List II chemicals include, among others, known as “ecstasy” or “molly”), and other drugs.68 List II chemicals include, among others,
solvents such as acetone, hydrochloric acid, and sulfuric acid.69 solvents such as acetone, hydrochloric acid, and sulfuric acid.69
Listed chemicals are subject to some controls similar to those that apply to controlled Listed chemicals are subject to some controls similar to those that apply to controlled
substances.70 In addition, entities that substances.70 In addition, entities that ~~sel~~ sell listed chemicals must record the transactions, report listed chemicals must record the transactions, report
them to regulators, and comply with statutory limits on sales to a single purchaser.71 them to regulators, and comply with statutory limits on sales to a single purchaser.71
There are a number of differences between how controlled substance analogues and listed There are a number of differences between how controlled substance analogues and listed
chemicals are regulated. In addition, listed chemicals include only specific substances identified chemicals are regulated. In addition, listed chemicals include only specific substances identified
for control under the CSA by statute or rulemaking.72 By contrast, controlled substance analogues for control under the CSA by statute or rulemaking.72 By contrast, controlled substance analogues
need not be need not be ~~individual y~~ individually scheduled; they need only satisfy the statutory criteria.73 scheduled; they need only satisfy the statutory criteria.73
Scheduling Procedures
Substances may be added to or removed from a schedule or moved to a different schedule Substances may be added to or removed from a schedule or moved to a different schedule
through agency action or by legislation.74 As described below, the procedures for modifying a through agency action or by legislation.74 As described below, the procedures for modifying a
substance’s scheduling differ depending on whether Congress or DEA makes the change. substance’s scheduling differ depending on whether Congress or DEA makes the change.
Legislative Scheduling
Perhaps the most straightforward way to change a substance’s legal status under the CSA is for Perhaps the most straightforward way to change a substance’s legal status under the CSA is for
Congress to pass legislation to place a substance under control, alter its classification, or remove Congress to pass legislation to place a substance under control, alter its classification, or remove
it from control. The procedural requirements for administrative scheduling discussed in the it from control. The procedural requirements for administrative scheduling discussed in the
~~following~~ next section do not apply to legislativesection do not apply to legislative scheduling. scheduling. ~~Thus, Congress may use~~This means that scheduling legislation does not need to incorporate scientific and medical findings and is not subject to the Administrative Procedure Act (APA). Congress has used its legislative its legislative
scheduling power to respond quickly to regulate scheduling power to respond quickly to regulate ~~a drug that poses~~ drugs that pose an urgent concern. For an urgent concern. For
example, the Synthetic Drug Abuse Prevention Act of 2012 permanently added two synthetic example, the Synthetic Drug Abuse Prevention Act of 2012 permanently added two synthetic
cathinones (central nervous system stimulants) and certain cannabimimetic cathinones (central nervous system stimulants) and certain cannabimimetic substances (commonly referred to as synthetic marijuana) to Schedule I.75 More recently, in February 2020, Congress enacted the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act, which placed a broad class of fentanyl analogues in Schedule I on a temporary basis.76 ~~substances~~

~~66 21 C.F.R. § 1300.02(b18).~~
~~67 Id. § 1300.02(b19).~~
68 68 Id. § 1310.02(a). § 1310.02(a).
69 69 Id. § 1310.02(b). § 1310.02(b).
70 70 See, e.g., 21 U.S.C., 21 U.S.C. § § 823(h) (requiring DEA registration to distribute List I chemicals); 823(h) (requiring DEA registration to distribute List I chemicals); id. § 841(c) (imposing § 841(c) (imposing
criminal penalties for, among other things, “possess[ing] or distribut[ing] a listed chemical knowing, or having criminal penalties for, among other things, “possess[ing] or distribut[ing] a listed chemical knowing, or having
reasonable causereasonable cause to believe, that the listed chemical willto believe, that the listed chemical will be usedbe used to manufacture a controlled substance except as to manufacture a controlled substance except as
authorized by” the CSA);authorized by” the CSA); id. § 842(a) (imposing civil and criminal penalties for certain unauthorized § 842(a) (imposing civil and criminal penalties for certain unauthorized ~~r etail~~retail sales of sales of
listed chemicals). listed chemicals).
71 71 Id. § 830. § 830.
72 21 U.S.C.72 21 U.S.C. §§ §§ 802(34), (35). 802(34), (35).
73 73 See, e.g., , ~~Hofstatter, 8 F.3d at 321-22 (~~United States v. Hofstatter, 8 F.3d 316, 321-22 (6th Cir. 1993) (upholding against Fifth Amendment vagueness challenge the statutory criteria upholding against Fifth Amendment vagueness challenge the statutory criteria
for controlled substance analogues). for controlled substance analogues).
74 74 See 21 U.S.C. 21 U.S.C. § § 811; United States v. Ways, 832 F.3d 887, 893 (8th Cir. 2016) (summarizing the addition of certain 811; United States v. Ways, 832 F.3d 887, 893 (8th Cir. 2016) (summarizing the addition of certain
substancessubstances to Scheduleto Schedule I by legislation). 75 See P.L. 112-144, 126 Stat. 1130 (2012). 76 P.L. 116-114, 134 Stat. 103 (2020). For further discussion of~~I by legislation).~~
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~~(commonly referred to as synthetic marijuana) to Schedule I.75 More recently, in February 2020,~~
~~Congress enacted~~ the Temporary Reauthorization and Study of the Emergency Scheduling of the Temporary Reauthorization and Study of the Emergency Scheduling of
Fentanyl Analogues ActFentanyl Analogues Act~~, which placed a broad class of fentanyl analogues in Schedule I on a~~
~~temporary basis.76~~ and related legislation, see infra “Fentanyl Analogues.” Congressional Research Service 9 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress
Administrative Scheduling
DEA makes scheduling decisions through a complex DEA makes scheduling decisions through a complex administrative process requiring participation by other process requiring participation by other
agencies and the public.77 DEA may undertake administrative scheduling on its own initiative, at agencies and the public.77 DEA may undertake administrative scheduling on its own initiative, at
the request of the U.S. Department of Health and Human Services (HHS), or “on the petition of the request of the U.S. Department of Health and Human Services (HHS), or “on the petition of
any interested party.”78 With regard to the last route for initiating administrative scheduling, the any interested party.”78 With regard to the last route for initiating administrative scheduling, the
DEA Administrator may deny a petition to begin scheduling proceedings based on a finding that DEA Administrator may deny a petition to begin scheduling proceedings based on a finding that
“the grounds upon which the petitioner relies are not sufficient to justify the initiation“the grounds upon which the petitioner relies are not sufficient to justify the initiation of of
proceedings.”79 Denial of a petition to initiate scheduling proceedings is subject to judicial proceedings.”79 Denial of a petition to initiate scheduling proceedings is subject to judicial
review, but review, but ~~courts wil~~ a court may overturn a denial only if it overturn a denial only if it determines that the denial is arbitrary and capricious.80 is arbitrary and capricious.80
Before initiating Before initiating rulemaking proceedings, DEA must request a scientific and medical evaluation rulemaking proceedings, DEA must request a scientific and medical evaluation
of the substance at issue from the Secretary of HHS.81 The HHS Secretary has delegated the of the substance at issue from the Secretary of HHS.81 The HHS Secretary has delegated the
authority to prepare the scientific and medical evaluation to FDA.82 In preparing the evaluation, authority to prepare the scientific and medical evaluation to FDA.82 In preparing the evaluation,
FDA considers a number of factors, including the substance’s potential for abuse and dependence, FDA considers a number of factors, including the substance’s potential for abuse and dependence,
scientific evidence of its pharmacological effect, the state of current scientific knowledge scientific evidence of its pharmacological effect, the state of current scientific knowledge
regarding the substance, any risk the substance poses to the public health, and whether the regarding the substance, any risk the substance poses to the public health, and whether the
substance is an immediate precursor of an existing controlled substance.83 Based on those factors, substance is an immediate precursor of an existing controlled substance.83 Based on those factors,
FDA makes a recommendation FDA makes a recommendation onas to whether the substance should be controlled and, if so, in which whether the substance should be controlled and, if so, in which
schedule it should be placed.84 FDA’s scientific and medical findings are binding on DEA.85 schedule it should be placed.84 FDA’s scientific and medical findings are binding on DEA.85
Furthermore, if FDA recommends against controlling Furthermore, if FDA recommends against controlling ~~the~~a substance, DEA may not schedule substance, DEA may not schedule it.86 Upon receipt of FDA’s report, the DEA Administrator evaluates all of the relevant data and determines whether the substance should be scheduled, rescheduled, or removed from control.87 Before placing a substance on a schedule, the DEA Administrator must make specific findings that the substance meets the applicable criteria related to accepted medical use and potential for abuse and dependence.88 DEA scheduling decisions are subject to notice-and-comment rulemaking under the APA,89 meaning that interested parties must have the opportunity to submit comments on the DEA Administrator’s decision before it becomes final.90 77 The CSA grants the Attorney General the authority to administer its provisions. See, e.g., 21 U.S.C. § 811. The Attorney General has delegated that authority to the DEA Administrator. See 28 C.F.R. § 0.100(b). 78 21 U.S.C. § 811(a). 79 21 C.F.R. § 1308.43. 80 See Ams. for Safe Access v. DEA, 706 F.3d 438, 440 (D.C. Cir. 2013). 81 21 U.S.C. § 811(b). 82 See, e.g., DEA, Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV, 84 Fed. Reg. 27,943, 27,944 (June 17, 2019). 83 See 21 U.S.C. §§ 811(c)(1)-(8) (full list of factors FDA and DEA must consider in making scheduling decisions). 84 Id. § 811(b). 85 Id. 86 Id. 87 Id. Like FDA, the DEA Administrator is required to consider all the factors in 21 U.S.C. §§ 811(c)(1)-(8) in making this determination. 88 Id. § 812(b). 89 5 U.S.C. § 500, et seq. 90 21 U.S.C. § 811(a); see also Touby v. United States, 500 U.S. 160, 162-63 (1991). Congressional Research Service 10 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress ~~it.86~~

~~75 See Pub. L. No. 112-144, 126 Stat. 1130 (2012). An early congressional proposal to control some of those substances~~
~~was introduced in March 2011, see S. 605, 112th Cong. (2011), to respond to “ new and very dangerous substances~~
~~packaged as innocent products,” 157 Cong. Rec. S1830 (2011) (statement of Sen. Grassley). T he Synthetic Drug Abuse~~
~~Prevention Act was introduced on May 16, 2012, see S. 3190, 112th Cong. (2012), and became law as part of the Food~~
~~and Drug Safety and Innovation Act on July 9, 2012, Pub. L. No. 112 -144, 126 Stat. 1130 (2012).~~
~~76 Pub. L. 116-114, 134 Stat. 103 (2020). Absent further legislative or administrative action, the substances subject to~~
~~this legislation will remain in Schedule I until May 6, 2021. For further discussion of the T emporary Reauthorization~~
~~and Study of the Emergency Scheduling of Fentanyl Analogues Act , see CRS Legal Sidebar LSB10404,~~ ~~Scheduling of~~
~~Fentanyl Analogues: The New Legal Landscape, by Joanna R. Lampe.~~
~~77 T he CSA grants the Attorney General the authority to administer its provisions. See, e.g., 21 U.S.C. § 811. T he~~
~~Attorney General has delegated that authority to the DEA Administrator. See 28 C.F.R. § 0.100(b).~~
~~78 21 U.S.C. § 811(a).~~
~~79 21 C.F.R. § 1308.43.~~
~~80 See Ams. for Safe Access v. DEA, 706 F.3d 438, 440 (D.C. Cir. 2013).~~
~~81 21 U.S.C. § 811(b).~~
~~82 See, e.g., DEA, Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV, 84 Fed. Reg. 27,943,~~
~~27,944 (June 17, 2019).~~
~~83 See 21 U.S.C. §§ 811(c)(1)-(8) (full list of factors FDA and DEA must consider in making scheduling decisions).~~
~~84 Id. § 811(b).~~
85 Id.
86 Id.
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~~Upon receipt of FDA’s report, the DEA Administrator evaluates al of the relevant data and~~
~~determines whether the substance should be scheduled, rescheduled, or removed from control.87~~
~~Before placing a substance on a schedule, the DEA Administrator must make specific findings~~
~~that the substance meets the applicable criteria related to accepted medical use and potential for~~
~~abuse and dependence.88 DEA scheduling decisions are subject to notice-and-comment~~
~~rulemaking under the Administrative Procedure Act,89 meaning that interested parties must have~~
~~the opportunity to submit comments on the DEA Administrator’s decision before it becomes~~
~~final.90~~
The DEA Administrator’s decision whether to schedule, reschedule, or deschedule a substance The DEA Administrator’s decision whether to schedule, reschedule, or deschedule a substance
through the ordinary administrative process is subject to judicial review.91 Such review is through the ordinary administrative process is subject to judicial review.91 Such review is
~~general y~~generally deferential: courts accept DEA’s interpretation of the CSA as long as the interpretation deferential: courts accept DEA’s interpretation of the CSA as long as the interpretation
of ambiguous statutory text is reasonable,92 and the CSA provides that the DEA Administrator’s of ambiguous statutory text is reasonable,92 and the CSA provides that the DEA Administrator’s
findings of fact are “conclusive” on judicial review if the findings are supported by substantial findings of fact are “conclusive” on judicial review if the findings are supported by substantial
evidence.93 evidence.93 ~~Overal~~ Overall, courts , courts ~~wil~~ set aside DEA action “only if it is ‘arbitrary, capricious, an abuse set aside DEA action “only if it is ‘arbitrary, capricious, an abuse
of discretion, or otherwise not in accordance with law.’”94 of discretion, or otherwise not in accordance with law.’”94
Emergency Scheduling
Ordinary DEA scheduling decisions Ordinary DEA scheduling decisions ~~are~~ made through notice-and-comment rulemaking made through notice-and-comment rulemaking ~~and~~ can can
take years to consider and finalize.95 Recognizing that in some cases faster scheduling may be take years to consider and finalize.95 Recognizing that in some cases faster scheduling may be
appropriate, Congress amended the CSA through the Comprehensive Crime Control Act of 198496 appropriate, Congress amended the CSA through the Comprehensive Crime Control Act of 198496
~~to al ow~~to allow the DEA the DEA Administrator to place a substance in Schedule I temporarily when “necessary Administrator to place a substance in Schedule I temporarily when “necessary
to avoid an imminent hazard to the public safety.”97 Before issuing a temporary scheduling order, to avoid an imminent hazard to the public safety.”97 Before issuing a temporary scheduling order,
the DEA Administrator must provide 30 days’ notice to the public and the Secretary of HHS the DEA Administrator must provide 30 days’ notice to the public and the Secretary of HHS
stating the basis for temporary scheduling.98 In issuing a temporary scheduling order, the DEA stating the basis for temporary scheduling.98 In issuing a temporary scheduling order, the DEA
Administrator must consider only a subset of the factors relevant to permanent scheduling: the Administrator must consider only a subset of the factors relevant to permanent scheduling: the
history and current pattern of abuse of the substance at issue; the scope, duration, and significance history and current pattern of abuse of the substance at issue; the scope, duration, and significance
of abuse; and the risk to the public health.99 The DEA Administrator must also consider any of abuse; and the risk to the public health.99 The DEA Administrator must also consider any
comments from the Secretary of HHS.100 comments from the Secretary of HHS.100

~~87 Id. Like FDA, the DEA Administrator is required to consider all the factors in 21 U.S.C. §§ 811(c)(1)-(8) in making~~
~~this determination.~~
~~88 Id. § 812(b).~~
~~89 5 U.S.C. § 500, et seq.~~
~~90 21 U.S.C. § 811(a); see also T ouby v. United States, 500 U.S. 160, 162-63 (1991).~~
~~91 See id. § 877.~~
92 See ~~All. for Cannabis T herapeutics~~ Pursuant to amendments in the Synthetic Drug Abuse Prevention Act of 2012,101 a substance may be temporarily scheduled for up to two years; if permanent scheduling proceedings are pending, the DEA Administrator may extend the temporary scheduling period for up to one additional year.102 If DEA completes the permanent scheduling process for a substance while a temporary scheduling order is in effect, the temporary scheduling order is vacated.103 The CSA provides that emergency scheduling orders are not subject to judicial review.104 91 See id. § 877. 92 See All. for Cannabis Therapeutics v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991) (citing Chevron U.S.A. Inc. v. v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991) (citing Chevron U.S.A. Inc. v.
Natural ResourcesNatural Resources Defense Council,Defense Council, Inc., 467 U.S. 837, 843Inc., 467 U.S. 837, 843 -45 (1984)). -45 (1984)).
93 21 U.S.C. 93 21 U.S.C. § 877. § 877.
94 94 See, e.g., Ams. for Safe, Ams. for Safe Access v. DEA, 706 F.3d 438, 449 (D.C. Cir. 2013) (quoting 5 U.S.C.Access v. DEA, 706 F.3d 438, 449 (D.C. Cir. 2013) (quoting 5 U.S.C. § 706(2)(A)). § 706(2)(A)).
95 95 See, e.g., Washington v. Barr, 925 F.3d 109, 120 (2d Cir. 2019) (“, Washington v. Barr, 925 F.3d 109, 120 (2d Cir. 2019) (“ Plaintiffs document that the average delay in Plaintiffs document that the average delay in
decidingdeciding petitions to reclassify drugs underpetitions to reclassify drugs under the CSAthe CSA is approximately nine years.”). is approximately nine years.”).
96 96 ~~Pub. L. No~~P.L. 98-473, 98 Stat. 1976 (1984). . 98-473, 98 Stat. 1976 (1984).
97 21 U.S.C.97 21 U.S.C. § 811(h)(1). § 811(h)(1).
98 21 U.S.C.98 21 U.S.C. § 811(h)(1). § 811(h)(1).
99 99 Id. § 811(h)(3). § 811(h)(3).
100 100 Id. § 811(h)(4). § 811(h)(4).
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~~Pursuant to amendments in the Synthetic Drug Abuse Prevention Act of 2012,101 a substance may~~
~~be temporarily scheduled for up to two years; if permanent scheduling proceedings are pending,~~
~~the DEA Administrator may extend the temporary scheduling period for up to one additional~~
~~year.102 A temporary scheduling order is vacated once permanent scheduling proceedings are~~
~~completed with respect to the substance at issue.103 The CSA provides that emergency scheduling~~
~~orders are not subject to judicial review.104~~
~~DEA has recently used its emergency scheduling power to temporarily control certain analogues~~
~~to the opioid fentanyl105~~101 P.L. 112-144, 126 Stat. 993 (2012). 102 21 U.S.C. § 811(h)(2). As originally enacted, the Comprehensive Crime Control Act of 1984 authorized temporary scheduling for up to one year, with a possible extension for up to six months if permanent scheduling proceedings were pending. See 98 Stat. 2072. 103 Id. § 811(h)(5). 104 Id. § 811(h)(6). Congressional Research Service 11 link to page 27 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress DEA has recently used its emergency scheduling power to temporarily control a large class of analogues to the opioid fentanyl,105 other synthetic opioids,106 and several synthetic cannabinoids. and several synthetic cannabinoids.~~106~~107
International Treaty Obligations
The The CSA outlines procedures for scheduling controlled substances based on the United States’ treaty obligations. The United States is a party to the Single Convention on Narcotic Drugs of 1961, United States is a party to the Single Convention on Narcotic Drugs of 1961, ~~whic h~~which was was
designed to establish controls on the international and domestic traffic in narcotics, coca leaf, designed to establish controls on the international and domestic traffic in narcotics, coca leaf,
cocaine, and marijuana.cocaine, and marijuana.~~107~~108 The treaty requires signatories, among other things, to criminalize any The treaty requires signatories, among other things, to criminalize any
“cultivation, production, manufacture, extraction, preparation, possession, offering, offering for “cultivation, production, manufacture, extraction, preparation, possession, offering, offering for
sale, distribution, purchase, sale, .sale, distribution, purchase, sale, . . .. importation and exportation of drugs” that are subject to the . importation and exportation of drugs” that are subject to the
Convention, except to the extent the Convention authorizes such activities.Convention, except to the extent the Convention authorizes such activities.~~108~~109
The United States is also party to the Convention on Psychotropic Substances of 1971, which was The United States is also party to the Convention on Psychotropic Substances of 1971, which was
designed to establish similar control over stimulants, depressants, and designed to establish similar control over stimulants, depressants, and ~~hal ucinogens.109~~hallucinogens.110 The The
Convention on Psychotropic Substances requires parties to adopt various controls applicable to Convention on Psychotropic Substances requires parties to adopt various controls applicable to
controlled substances, including mandating licenses for manufacture and distribution, requiring controlled substances, including mandating licenses for manufacture and distribution, requiring
prescriptions for dispensing such substances, and adopting measures “for the repression of acts prescriptions for dispensing such substances, and adopting measures “for the repression of acts
contrary to laws or regulations” adopted pursuant to treaty obligations.contrary to laws or regulations” adopted pursuant to treaty obligations.~~110~~111
If existing controls of a drug are less stringent than those required by the United States’ treaty If existing controls of a drug are less stringent than those required by the United States’ treaty
obligations, the CSA directs the DEA Administrator to “issue an order controlling such drug obligations, the CSA directs the DEA Administrator to “issue an order controlling such drug
under the schedule he deems most appropriate to carry out such obligations.”under the schedule he deems most appropriate to carry out such obligations.”~~111~~112 Scheduling Scheduling
pursuant to international treaty obligations does not require the factual findings that are necessary pursuant to international treaty obligations does not require the factual findings that are necessary
for other administrative scheduling actions, and may be implemented without regard to the for other administrative scheduling actions, and may be implemented without regard to the
procedures outlined for regular administrative scheduling.procedures outlined for regular administrative scheduling.~~112~~

~~101 Pub. L. No. 112-144, 126 Stat. 993 (2012).~~
~~102 Id. § 811(h)(2).~~
~~103 Id. § 811(h)(5).~~
~~104 Id. § 811(h)(6).~~
105 See ~~DEA, Schedules of Controlled Substances: T emporary~~113 Registration Requirements Once a substance is brought within the scope of the CSA through one of the scheduling processes discussed above, almost any person or organization that handles that substance, except for the end 105 See DEA, Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule Placement of Fentanyl-Related Substances in Schedule I, I,
83 Fed.83 Fed. Reg. 5188 (Feb. 6, 2018); Reg. 5188 (Feb. 6, 2018); see also ~~CRS Legal Sidebar LSB10404,~~ ~~Scheduling of Fentanyl Analogues: The New~~
~~Legal Landscape, by Joanna R. Lampe.~~
106 See ~~DEA, Schedules of Controlled Substances: T emporary~~infra “Fentanyl Analogues.” 106 See DEA, Schedules of Controlled Substances: Temporary Placement of Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene, Metonitazene, N-Pyrrolidino etonitazene, and Protonitazene in Schedule I, 87 Fed. Reg. 21,556 (Apr. 12, 2022). 107 See DEA, Schedules of Controlled Substances: Temporary Placement of 5F-EDMBPINACA, 5F-MDMB-PICA, Placement of 5F-EDMBPINACA, 5F-MDMB-PICA,
FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 into ScheduleFUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 into Schedule I, 84 Fed. Reg.I, 84 Fed. Reg. 15,505 (Apr. 16, 2019). 15,505 (Apr. 16, 2019).
~~107~~ 108 See United Nations Single United Nations Single Convention on Narcotic Drugs, 1961, Mar. 30, 1961, 18 U.S.TConvention on Narcotic Drugs, 1961, Mar. 30, 1961, 18 U.S.T . 1407, preamble (stating . 1407, preamble (stating
the parties’ desire “the parties’ desire “ to conclude a generally acceptable international convention replacing existing treaties on narcotic to conclude a generally acceptable international convention replacing existing treaties on narcotic
drugs,drugs, limiting such drugslimiting such drugs to medical and scientific use”). to medical and scientific use”).
~~108~~109 Id. art. 36. art. 36.
~~109~~110 United Nations Convention on Psychotropic Substances, Feb. 21, 1971, 32 U.S.T United Nations Convention on Psychotropic Substances, Feb. 21, 1971, 32 U.S.T . 543. . 543.
~~110~~111 Id. art. 2(1)(7). art. 2(1)(7).
~~111~~112 21 U.S.C. 21 U.S.C. § 811(d)(1). § 811(d)(1).
~~112~~113 Id.
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link to page link to page 1718 The Controlled Substances Act (CSA): A Legal Overview for the ~~117th~~118th Congress ~~Congress~~

~~Registration Requirements~~
~~Once a substance is brought within the scope of the CSA through one of the scheduling processes~~
~~discussed above, almost any person or organization that handles that substance, except for the end~~
user, becomes subject to a comprehensive system of regulatory requirements.user, becomes subject to a comprehensive system of regulatory requirements.~~113~~114 The goal of the The goal of the
regulatory scheme is to create a “closed system” of distribution in which only authorized handlers regulatory scheme is to create a “closed system” of distribution in which only authorized handlers
may distribute controlled substances.may distribute controlled substances.~~114~~115 Central to the closed system of distribution is the Central to the closed system of distribution is the
requirement that individuals or entitiesrequirement that individuals or entities that work with controlled substances register with DEA. that work with controlled substances register with DEA.
Those covered entities, which include manufacturers, distributors, practitioners, and Those covered entities, which include manufacturers, distributors, practitioners, and
pharmacists,pharmacists,~~115~~116 are referred to as are referred to as registrants..~~116 As~~117 DEA has described the movement of a DEA has described the movement of a
pharmaceutical controlled substance from the manufacturer to the patientpharmaceutical controlled substance from the manufacturer to the patient,
~~[A] controlled substance, after being manufactured by a DEA -registered~~ as follows: [A] controlled substance, after being manufactured by a DEA-registered manufacturer, manufacturer,
may be transferred to a DEA-registered distributor for subsequent distribution to a DEAmay be transferred to a DEA-registered distributor for subsequent distribution to a DEA --
registered retail pharmacy. After aregistered retail pharmacy. After a DEA-registered practitioner, such as a physician or a DEA-registered practitioner, such as a physician or a
dentist, issues a prescription for a controlled substance to a patient .dentist, issues a prescription for a controlled substance to a patient . . .. , that patient can fill . , that patient can fill
that prescription at a retail pharmacy to obtain that controlled substance. In this system, the that prescription at a retail pharmacy to obtain that controlled substance. In this system, the
manufacturer, the distributor, the practitioner, and the retail pharmacy are all required to manufacturer, the distributor, the practitioner, and the retail pharmacy are all required to
be DEA registrants, or to be exempted from the requirement of registration, to participate be DEA registrants, or to be exempted from the requirement of registration, to participate
in the process.in the process.~~117~~118
As discussed further below, registrants must maintain records of transactions involving controlled As discussed further below, registrants must maintain records of transactions involving controlled
substances, establish security measures to prevent theft of such substances, and monitor for substances, establish security measures to prevent theft of such substances, and monitor for
suspicious orders to prevent misuse and diversion.suspicious orders to prevent misuse and diversion.~~118~~119 Thus, the registration system aims to ensure Thus, the registration system aims to ensure
that any controlled substance is always accounted for and under the control of a DEA-registered that any controlled substance is always accounted for and under the control of a DEA-registered
person until it reaches a patient or is destroyed.person until it reaches a patient or is destroyed.~~119~~120
Entities Required to Register
Under the CSA, every person who produces, distributes, or dispenses any controlled substance, or Under the CSA, every person who produces, distributes, or dispenses any controlled substance, or
who proposes to engage in any of those activities, must register with DEA, unless an exemption who proposes to engage in any of those activities, must register with DEA, unless an exemption
~~applies.120 Significantly, the~~applies.121 The CSA exempts from registration individual consumers of CSA exempts from registration individual consumers of ~~control ed~~
controlled substances, such as patients and their family members, whom the Act refers to as “ultimate substances, such as patients and their family members, whom the Act refers to as “ultimate

~~113 See id. § 822.~~
~~114~~users.”122 Ultimate users and other entities exempt from the CSA’s registration provisions can still violate the Act’s criminal trafficking provisions if they engage in unauthorized activities.123 114 See id. § 822. 115 DEA, Electronic Prescriptions for Controlled Substances, DEA, Electronic Prescriptions for Controlled Substances, 75 Fed. Reg.75 Fed. Reg. 16 16,235, 16,237 (Mar. 31, 2010). ,235, 16,237 (Mar. 31, 2010).
~~115~~116 21 U.S.C. 21 U.S.C. § 822(a). § 822(a).
~~116~~117 21 C.F.R. § 21 C.F.R. § 1300.02(b)(24). 1300.02(b)(24).
~~117~~118 DEA, Disposal of Controlled Substances DEA, Disposal of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration, 74by Persons Not Registered With the Drug Enforcement Administration, 74
Fed.Fed. Reg. 3480, 3481 (Jan. 21, 2009). Reg. 3480, 3481 (Jan. 21, 2009).
~~118~~ 119 See infra “Obligations of Registrants.”
~~119~~120 See DEA, Definition and Registration of Reverse Distributors, 70 Fed. Reg. DEA, Definition and Registration of Reverse Distributors, 70 Fed. Reg. 22 22,591, 22,591 (May 2, 2005). ,591, 22,591 (May 2, 2005).
~~120~~121 21 U.S.C. 21 U.S.C. § 822; 21 C.F.R.§ 822; 21 C.F.R. Part 1301. Part 1301. See also 21 U.S.C. § 21 U.S.C. § 957 (957 (~~section~~provision of the Controlled Substances Import and of the Controlled Substances Import and
Export Act imposing registration requirements for importers and exporters of controlled substances).Export Act imposing registration requirements for importers and exporters of controlled substances).
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~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~users.”121 Ultimate users and other entities exempt from the CSA’s registration provisions can~~
~~stil violate the Act’s criminal trafficking provisions if they engage in unauthorized activities.122~~
~~Manufacturers and distributors of controlled substances, such as pharmaceutical companies, must~~
~~register with DEA annual y.123 By contrast, entities that dispense controlled substances, such as~~
~~hospitals, pharmacies, and individual medical practitioners and pharmacists, may obtain~~
~~registrations lasting between one and three years.124~~ 122 21 U.S.C. § 822(c)(3). See also id. § 802(25) (defining “ultimate user” as a “person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household”). DEA has explained that ultimate users need not register because the controlled substances in their possession “are no longer part of the closed system of distribution and are no longer subject to DEA’s system of corresponding accountability.” DEA, Definition and Registration of Reverse Distributors, 68 Fed. Reg. 41,222, 41,226 (proposed July 11, 2003). Some other exemptions are specified by statute, see 21 U.S.C. §§ 822(c)(1), (2); or by regulation, see 21 C.F.R. §§ 1301.22-24. 123 Cf. United States v. Mancuso, 718 F.3d 780, 798 (9th Cir. 2013) (rejecting an argument that defendant was “merely ‘an ultimate user’” of cocaine because he shared the drug with others, and sharing drugs constitutes “distribution” for Congressional Research Service 13 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress Manufacturers and distributors of controlled substances, such as pharmaceutical companies, must register with DEA annually.124 By contrast, entities that dispense controlled substances, such as hospitals, pharmacies, and individual medical practitioners and pharmacists, may obtain registrations lasting between one and three years.125 Registrations specify the extent to which Registrations specify the extent to which
registrants may manufacture, possess, distribute, or dispense controlled substances, and each registrants may manufacture, possess, distribute, or dispense controlled substances, and each
registrant may engage only in the specific activities covered by its registration. In some instances, registrant may engage only in the specific activities covered by its registration. In some instances,
applicants must obtain more than one registration to comply with the CSA. For example, separate applicants must obtain more than one registration to comply with the CSA. For example, separate
registrations are required for each principal place of business where controlled substances are registrations are required for each principal place of business where controlled substances are
manufactured, distributed, imported, exported, or dispensed.manufactured, distributed, imported, exported, or dispensed.~~125~~126 Special registration is required for Special registration is required for
certain activities, including operating an opioid treatment program such as a methadone clinic.certain activities, including operating an opioid treatment program such as a methadone clinic.~~126~~127
The CSA directs the DEA Administrator to issue a registration if it would be consistent with the The CSA directs the DEA Administrator to issue a registration if it would be consistent with the
public interest, and the Act outlines the criteria the DEA Administrator must consider when public interest, and the Act outlines the criteria the DEA Administrator must consider when
evaluating the public interest.evaluating the public interest.~~127~~128 The criteria vary depending on (1) whether the applicant is a The criteria vary depending on (1) whether the applicant is a
manufacturer, distributor, researcher, or practitionermanufacturer, distributor, researcher, or practitioner, and (2) the classification of the controlled and (2) the classification of the controlled
~~substances~~substance(s) that are the focus of the application. However, the requirements that are the focus of the application. However, the requirements ~~general y~~generally serve to serve to
help DEA determine whether the applicant has demonstrated the capacity to maintain effective help DEA determine whether the applicant has demonstrated the capacity to maintain effective
controls against diversion and comply with applicable laws.controls against diversion and comply with applicable laws.~~128~~129
The registration of an individual The registration of an individual or organization expires at the end of the registration period or organization expires at the end of the registration period
unless it is renewed.unless it is renewed.~~129~~130 Registration also ends when the registrant dies, ceases legal existence, or Registration also ends when the registrant dies, ceases legal existence, or
discontinues business or professional practice.discontinues business or professional practice.~~130~~131 A registration cannot be transferred to someone A registration cannot be transferred to someone
else without the express, written consent of the DEA Administrator.else without the express, written consent of the DEA Administrator.~~131~~

~~121 21 U.S.C. § 822(c)(3). See also id. § 802(25) (defining “ultimate user” as a “ person who has lawfully obtained, and~~
~~who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal~~
~~owned by him or by a member of his household”). DEA has explained that ultimate users need not register because the~~
~~controlled substances in their possession “ are no longer part of the closed system of distribution and are no longer~~
~~subject to DEA’s system of corresponding accountability.” DEA, Definition and Registration of Reverse Distributors,~~
~~68 Fed. Reg. 41,222, 41,226 (proposed July 11, 2003). Some other exemptions are specified by statute, see 21 U.S.C.~~
~~§§ 822(c)(1), (2); or by regulation, see 21 C.F.R. §§ 1301.22-24.~~
~~122 Cf. United States v. Mancuso, 718 F.3d 780, 798 (9th Cir. 2013) (rejecting an argument that defendant was “merely~~
~~‘an ultimate user’” of cocaine because he shared the drug with others, and sharing drugs constitutes “distribution” for~~
~~purposes of the CSA’s~~ 132 Obligations of Registrants Recordkeeping and Reporting The CSA and its implementing regulations impose multiple recordkeeping and reporting requirements on registrants. Registrants must undertake a biennial inventory of all stocks of controlled substances they have on hand and maintain records of each controlled substance they manufacture, receive, sell, deliver, or otherwise dispose of.133 In addition, a controlled substance in Schedule I or II may be distributed only pursuant to a written order from the recipient of the purposes of the CSA’s trafficking provisions, “even if there is no commercial scheme involved”). 124 21 U.S.C. § 822(a)(2). 125 Id. § 822(a)(1). 126 Id. § 822(e)(1). 127~~trafficking provisions, “even if there is no commercial scheme involved”).~~
~~123 21 U.S.C. § 822(a)(2).~~
~~124 Id. § 822(a)(1).~~
~~125 Id. § 822(e)(1).~~
~~126~~ Id. § 823(g); § 823(g); see also CRSCRS In FocusIn Focus IF10219, IF10219, Opioid Treatment Programs and Related Federal Regulations, by , by
Johnathan H. Duff. Johnathan H. Duff.
~~127~~128 Id. § 823(a)-(f). § 823(a)-(f).
~~128~~129 Id.
~~129~~130 21 C.F.R. §§ 21 C.F.R. §§ 1301.13(c), (d). 1301.13(c), (d).
~~130~~131 Id. § 1301.52. § 1301.52.
~~131~~132 Id. § 1301.52(b). § 1301.52(b).
133 21 U.S.C. § 827; 21 C.F.R. Part 1304. Congressional Research Service Congressional Research Service
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The Controlled Substances Act (CSA): A Legal Overview for the ~~117th~~118th Congress substance.134 ~~Congress~~

~~Obligations of Registrants~~
~~Recordkeeping and Reporting~~
~~The CSA and its implementing regulations impose multiple recordkeeping and reporting~~
~~requirements on registrants. Registrants must undertake a biennial inventory of al stocks of~~
~~control ed substances they have on hand, and maintain records of each controlled substance they~~
~~manufacture, receive, sel , deliver, or otherwise dispose of.132 In addition, controlled substances in~~
~~Schedules I and II may only be distributed pursuant to a written order.133~~ Copies of each order Copies of each order
form must be transmitted to DEA.form must be transmitted to DEA.~~134~~135 Records of orders must be preserved for two years and made Records of orders must be preserved for two years and made
~~available~~ available for government review upon request.for government review upon request.~~135~~136
Registrants are also required to “design and operate a system to identify suspicious orders” and to Registrants are also required to “design and operate a system to identify suspicious orders” and to
notify DEA of any suspicious orders they detect.notify DEA of any suspicious orders they detect.~~136~~137 DEA regulations provide that “[s]uspicious DEA regulations provide that “[s]uspicious
orders include orders of unusual size, orders deviating orders include orders of unusual size, orders deviating ~~substantial y~~substantially from a normal pattern, and from a normal pattern, and
orders of unusual frequency.”orders of unusual frequency.”~~137~~138 That list is not exhaustive, however—courts have suggested that That list is not exhaustive, however—courts have suggested that
orders may be suspicious if, for example, a pharmacy mostly orders may be suspicious if, for example, a pharmacy mostly ~~sel s~~sells controlled substances rather controlled substances rather
than a more typical mix of controlled and than a more typical mix of controlled and ~~noncontrolled~~non-controlled medications, medications, if many customers pay for many customers pay for
~~control ed~~controlled substances with cash, or substances with cash, or if pharmacies purchase drugs at a price higher than insurance pharmacies purchase drugs at a price higher than insurance
would reimburse.would reimburse.~~138~~139
Inspections
The CSA permits the DEA Administrator to inspect the establishment of any registrant or The CSA permits the DEA Administrator to inspect the establishment of any registrant or
applicant for registration.applicant for registration.~~139~~140 DEA regulations express the agency’s intent “to inspect DEA regulations express the agency’s intent “to inspect al
all manufacturers of controlled substances listed in Schedules I and II and distributors of controlled manufacturers of controlled substances listed in Schedules I and II and distributors of controlled
substances listed in Schedule I once each year,” and other manufacturers and distributors of substances listed in Schedule I once each year,” and other manufacturers and distributors of
controlled substances “as circumstances may require.”controlled substances “as circumstances may require.”~~140~~141 Absent the consent of the registrant or Absent the consent of the registrant or
special circumstances such as an imminent danger to health or safety, a warrant is required for special circumstances such as an imminent danger to health or safety, a warrant is required for
inspection.inspection.~~141~~142 “Any judge of the United States or of a State court of record, or any United States “Any judge of the United States or of a State court of record, or any United States
magistrate judge” may issue such a warrant “within his territorial jurisdiction.”magistrate judge” may issue such a warrant “within his territorial jurisdiction.”~~142~~143 Issuance of a Issuance of a
warrant requires probable cause.warrant requires probable cause.~~143~~144 The CSA defines probable cause as “a valid public interest in The CSA defines probable cause as “a valid public interest in
the effective enforcement of this subchapter or regulations thereunder sufficient to justify” the the effective enforcement of this subchapter or regulations thereunder sufficient to justify” the
inspection at issue.inspection at issue.~~144~~

~~132 21 U.S.C. § 827; 21 C.F.R. Part 1304.~~
~~133 21 U.S.C. § 828; 21 C.F.R. Part 1305.~~
~~134 21 U.S.C. § 828(c)(2).~~
~~135 Id. § 828(c)(1).~~
~~136 Id. § 832.~~
~~137 21 C.F.R. § 1304.74(b).~~
~~138~~145 Security The CSA’s implementing regulations require all registrants to “provide effective controls and procedures to guard against theft and diversion of controlled substances.”146 The regulations establish specific physical security requirements, which vary depending on the type of registrant and the classification of the controlled substance at issue.147 For example, practitioners148 subject 134 21 U.S.C. § 828; 21 C.F.R. Part 1305. 135 21 U.S.C. § 828(c)(2). 136 Id. § 828(c)(1). 137 Id. § 832. 138 21 C.F.R. § 1304.74(b). 139 See Masters Pharmas. Inc. v. DEA, 861 F.3d 206, 220 (D.C. Cir. 2017). Masters Pharmas. Inc. v. DEA, 861 F.3d 206, 220 (D.C. Cir. 2017).
~~139~~140 21 U.S.C. 21 U.S.C. § 822(f). § 822(f).
~~140~~141 21 C.F.R. §1316.13. 21 C.F.R. §1316.13.
~~141~~142 21 U.S.C. 21 U.S.C. § 880(c). § 880(c).
~~142~~143 Id. § 880(d)(1). § 880(d)(1).
~~143~~144 Id.
~~144~~145 Id. ~~T he~~The CSA’s CSA’s definition of probable causedefinition of probable cause is conceptually distinct from what is requiredis conceptually distinct from what is required ~~under the Fourth~~
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~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~Security~~
~~The CSA’s implementing regulations require al registrants to “provide effective controls and~~
~~procedures to guard against theft and diversion of controlled substances.”145 The regulations~~
~~establish specific physical security requirements, which vary depending on the type of registrant~~
~~and the classification of the controlled substance at issue.146 For example, practitioners147 subject~~ under the Fourth Amendment. See United States v. Schiffman, 572 F.2d 1137, 1139-40 (5th Cir. 1978). 146 21 C.F.R. § 1301.71. 147 Id. §§ 1301.72-76. 148 The CSA defines “practitioner” to include any “physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which Congressional Research Service 15 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress
to CSA registration must store controlled substances “in a securely locked, to CSA registration must store controlled substances “in a securely locked, ~~substantial y~~substantially
constructed cabinet.”constructed cabinet.”~~148~~149 In addition to those physical security requirements, practitioners may not In addition to those physical security requirements, practitioners may not
“employ, as an agent or employee who has access to controlled substances” any person who has “employ, as an agent or employee who has access to controlled substances” any person who has
been convicted of a felony related to controlled substances, had an application for CSA been convicted of a felony related to controlled substances, had an application for CSA
registration denied, had a CSA registration revoked, or surrendered a CSA registration for registration denied, had a CSA registration revoked, or surrendered a CSA registration for
cause.cause.~~149~~150 Registered non-practitioners must store Registered non-practitioners must store ~~control ed~~controlled substances in Schedules I and II in a substances in Schedules I and II in a
safe, steel cabinet, or vault that meets certain specifications.safe, steel cabinet, or vault that meets certain specifications.~~150~~151 Non-practitioners must further Non-practitioners must further
ensure that controlled substance storage areas are “accessible only to an absolute minimum ensure that controlled substance storage areas are “accessible only to an absolute minimum
number of number of ~~specifical y~~specifically authorized employees.” authorized employees.”~~151~~
152 Quotas
To prevent the production of excess amounts of controlled substances, which may increase the To prevent the production of excess amounts of controlled substances, which may increase the
~~likelihood~~ likelihood of diversion, the CSA directs DEA to set aggregate production quotas for of diversion, the CSA directs DEA to set aggregate production quotas for ~~control ed~~controlled
substances in Schedules I and II and for ephedrine, pseudoephedrine, and substances in Schedules I and II and for ephedrine, pseudoephedrine, and
phenylpropanolamine.phenylpropanolamine.~~152~~153 The DEA Administrator is also required to set individual The DEA Administrator is also required to set individual quotas for each quotas for each
registered manufacturer seeking to produce such substances and to limit or reduce individual registered manufacturer seeking to produce such substances and to limit or reduce individual
quotas as necessary to prevent oversupply.quotas as necessary to prevent oversupply.~~153~~154 With respect to certain opioid medications, the Act With respect to certain opioid medications, the Act
further directs the DEA Administrator to estimate the amount of diversion of each opioid and further directs the DEA Administrator to estimate the amount of diversion of each opioid and
reduce quotas to account for such diversion.reduce quotas to account for such diversion.~~154~~155 DEA sets production quotas annually and can adjust the quotas for a calendar year based on changes in demand.156
Relatedly, the Controlled Substances Import and Export Act Relatedly, the Controlled Substances Import and Export Act ~~al ows~~allows the importation of certain the importation of certain
controlled substances and listed chemicals only in amounts the DEA Administrator determines to controlled substances and listed chemicals only in amounts the DEA Administrator determines to
be “necessary to provide for the medical, scientific, or other legitimate needs of the United be “necessary to provide for the medical, scientific, or other legitimate needs of the United
~~States.”155~~

~~Amendment . See United States v. Schiffman, 572 F.2d 1137, 1139-40 (5th Cir. 1978).~~
~~145 21 C.F.R. § 1301.71.~~
~~146 Id. §§ 1301.72-76.~~
~~147 T he CSA defines “practitioner” to include any “ physician, dentist, veterinarian, scientific investigator, pharmacy,~~
~~hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which~~
States.”157 he practices or doeshe practices or does research, to distribute, dispense, conduct research with respect to, administer, or useresearch, to distribute, dispense, conduct research with respect to, administer, or use in teaching or in teaching or
chemical analysis, a controlled substance in the course of professional practice or research.” 21 U.S.C. §chemical analysis, a controlled substance in the course of professional practice or research.” 21 U.S.C. § 802(21). 802(21). ~~T he~~The
Act and its implementing regulations do not define the term “nonAct and its implementing regulations do not define the term “non -practitioner,” but it appears to include registrants not -practitioner,” but it appears to include registrants not
engagedengaged in the practice of medicine, such as manufacturers and in the practice of medicine, such as manufacturers and ~~distribut ors.~~
~~148~~distributors. 149 21 C.F.R. §§ 21 C.F.R. §§ 1301.75(a), (b). 1301.75(a), (b).
~~149~~150 Id. § 1301.76(a). § 1301.76(a).
~~150~~151 21 C.F.R. § 21 C.F.R. § 1301.72(a). 1301.72(a).
~~151~~152 Id. § 1301.72(d). § 1301.72(d).
~~152~~153 21 U.S.C. 21 U.S.C. § 826(a); § 826(a); see also 21 C.F.R. § 21 C.F.R. § 1303.11. Ephedrine, pseudoephedrine, and phenylpropanolamine are List I 1303.11. Ephedrine, pseudoephedrine, and phenylpropanolamine are List I
chemicals that may be usedchemicals that may be used in the manufacture of in the manufacture of ~~methamphetamine.~~
~~153 Id. §§ 826(b), (c).~~
~~154 Id. § 826(i).~~
~~155 Id. § 952. T he Controlled Substances Import and Export Act also imposes controls on the exportation of controlled~~
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~~link to page 20~~ ~~The Controlled Substances Act (CSA): A Legal Overview for the 117th~~controlled substances such as methamphetamine or amphetamine. See DEA, Listed Chemicals Regulated Under the Controlled Substances Act (Dec. 20, 2021), https://www.deadiversion.usdoj.gov/schedules/orangebook/j_chemlist_regulated.pdf. 154 Id. §§ 826(b), (c). 155 Id. § 826(i). 156 See 21 C.F.R. § 1303.13. See also, e.g., DEA, Established Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2020, 84 Fed. Reg. 66,014, (Dec. 2, 2019) (setting aggregate production quotas for 2020); DEA, Adjustments to Aggregate Production Quotas for Certain Schedule II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine and Pseudoephedrine for 2020, in Response to the Coronavirus Disease 2019 Public Health Emergency, 85 Fed. Reg. 20,302 (Apr. 10, 2020) (adjusting aggregate production quotas for 2020 to meet increased need due to the COVID-19 pandemic). 157 21 U.S.C. § 952. The Controlled Substances Import and Export Act also imposes controls on the exportation of controlled substances, but does not establish specific export quotas. See id. § 953. Congressional Research Service 16 link to page 22 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress

Prescriptions
Under the CSA, controlled substances in Schedules II through IV must be provided directly to an Under the CSA, controlled substances in Schedules II through IV must be provided directly to an
ultimate user by a medical practitioner or dispensed pursuant to a prescription.ultimate user by a medical practitioner or dispensed pursuant to a prescription.~~156~~158 The Act does The Act does
not mandate that Schedule V substances be distributed by prescription, but such substances may not mandate that Schedule V substances be distributed by prescription, but such substances may
be dispensed only “for a medical purpose.”be dispensed only “for a medical purpose.”~~157~~159 As a practical matter, Schedule V substances are As a practical matter, Schedule V substances are
~~almost always~~usually dispensed pursuant to a prescription due to separate requirements under the FD&C dispensed pursuant to a prescription due to separate requirements under the FD&C
Act or state law.Act or state law.~~158~~160
Enforcement and Penalties
DEA is the federal agency primarily responsible for enforcing the CSA’s registration DEA is the federal agency primarily responsible for enforcing the CSA’s registration
requirements.requirements.~~159~~161 DEA may take formal or informal administrative action to enforce the DEA may take formal or informal administrative action to enforce the
registration requirements, including issuing warning letters, suspending or revoking an entity’s registration requirements, including issuing warning letters, suspending or revoking an entity’s
registration, and imposing fines.registration, and imposing fines.~~160~~162
The DEA Administrator may suspend or revoke a registration (or deny an application for The DEA Administrator may suspend or revoke a registration (or deny an application for
registration) on several bases, including findings that a registrant or applicant has falsified registration) on several bases, including findings that a registrant or applicant has falsified
application materials, been convicted of certain felonies, or “committed such acts as would render application materials, been convicted of certain felonies, or “committed such acts as would render
his registration .his registration . . .. inconsistent with the public interest.”. inconsistent with the public interest.”~~161~~163 Unless the DEA Administrator finds Unless the DEA Administrator finds
that there is an imminent danger to the public health or safety, the DEA Administrator must that there is an imminent danger to the public health or safety, the DEA Administrator must
provide the applicant or registrant with notice, the opportunity for a hearing, and the opportunity provide the applicant or registrant with notice, the opportunity for a hearing, and the opportunity
to submit a corrective plan before denying, suspending, or revoking a registration.to submit a corrective plan before denying, suspending, or revoking a registration.~~162~~164 Imminent Imminent
danger exists when, due to the failure of the registrant to comply with the registration danger exists when, due to the failure of the registrant to comply with the registration
requirements, “there is a substantial likelihoodrequirements, “there is a substantial likelihood of an immediate threat that death, serious bodily of an immediate threat that death, serious bodily
harm, or abuse of a controlled substance harm, or abuse of a controlled substance ~~wil~~ will occur in the absence of an immediate suspension of occur in the absence of an immediate suspension of
the registration.”the registration.”~~163 To il ustrate~~165 To illustrate, those conditions may be satisfied when a practitioner prescribes , those conditions may be satisfied when a practitioner prescribes

~~substances, but does not establish specific export quotas. See id. § 953.~~
156 Id. §§ 158 Id. §§ 829(a), (b). Substances829(a), (b). Substances in Schedulein Schedule I may not be dispensedI may not be dispensed by prescription because they have no accepted by prescription because they have no accepted
medical use. medical use.
~~157~~159 Id. § 829(c). § 829(c).
~~158~~160 Cf.,, e.g., Ga. Code, Ga. Code Ann. § 16-13-29.2 (permitting the State Board of Pharmacy to allow the sale of ScheduleAnn. § 16-13-29.2 (permitting the State Board of Pharmacy to allow the sale of Schedule V V
controlled substances without a prescription); Fla. Stat. Ann. § 893.08 (permitting the sale of Schedulecontrolled substances without a prescription); Fla. Stat. Ann. § 893.08 (permitting the sale of Schedule V V controlled controlled
substancessubstances over-the-counter by a registered pharmacist, if a prescription is not requiredover-the-counter by a registered pharmacist, if a prescription is not required under the FD&C Act). under the FD&C Act).
~~159~~ 161 See 28 C.F.R. 28 C.F.R. § 0.100(b) (delegating to the Administrator of DEA functions that relate to, arise from, or supplement § 0.100(b) (delegating to the Administrator of DEA functions that relate to, arise from, or supplement
investigations of matters concerning drugs under the Comprehensive Drug Abuseinvestigations of matters concerning drugs under the Comprehensive Drug Abuse Prevention and Control Act of 1970). Prevention and Control Act of 1970).
~~160~~162 See 21 U.S.C. 21 U.S.C. §§ §§ 822(f), 824(a), 842(c), 842(d). A person who must register under the CSA822(f), 824(a), 842(c), 842(d). A person who must register under the CSA but fails to do so is but fails to do so is
subjectsubject to prosecution under the Act’s general trafficking provisions. to prosecution under the Act’s general trafficking provisions. See United States v. Blanton, 730 F.2d 1425, United States v. Blanton, 730 F.2d 1425,
1429-30 (11th Cir. 1984); 1429-30 (11th Cir. 1984); see also infra “ ~~T rafficking~~Trafficking Provisions.”
~~161~~.” 163 21 U.S.C. 21 U.S.C. § 824(a). § 824(a).
~~162~~164 Id. §§ §§ 824(c), (d). Enforcement actions based on imminent danger are 824(c), (d). Enforcement actions based on imminent danger are not subject to subject to ~~review by DEA~~these requirements, but DEA provides an administrative review process for any denial, suspension, or revocation of registration, and a registrant , and a registrant
may seek judicialmay seek judicial review of the agency’s final decision underreview of the agency’s final decision under ~~the Administrative Procedure Act~~ the APA. . See, e.g., Volkman v. , Volkman v.
DEA, 567 F. 3d 215, 219 (6th Cir. 2006). DEA, 567 F. 3d 215, 219 (6th Cir. 2006).
~~163~~165 21 U.S.C. 21 U.S.C. § 824(d)(2). Congress added§ 824(d)(2). Congress added the opportunity to submit a corrective plan and the standard for determining the opportunity to submit a corrective plan and the standard for determining
whether an imminent danger to the public health or safety exists through the Ensuring Patient Access and Effective whether an imminent danger to the public health or safety exists through the Ensuring Patient Access and Effective
DrugDrug Enforcement Act of 2016, Enforcement Act of 2016, ~~Pub. L. No~~P.L. 114-145, 130 Stat. 354 (2016). Those amendments made it more difficult . 114-145, 130 Stat. 354 (2016). Those amendments made it more difficult
for DEA to issuefor DEA to issue immediate suspensionsimmediate suspensions~~: previously~~. Previously, the Act simply provided that “[t], the Act simply provided that “[t] he Attorney General [through the he Attorney General [through the
DEA Administrator] may, in his discretion, suspendDEA Administrator] may, in his discretion, suspend any registration simultaneously with the institution of proceedings any registration simultaneously with the institution of proceedings
under this section, in cases where he finds that there is an imminent dangerunder this section, in cases where he finds that there is an imminent danger to the public health or safety.” 21 U.S.C. to the public health or safety.” 21 U.S.C.
§ 824(d) (2000). As amended, the Act limits DEA’s§ 824(d) (2000). As amended, the Act limits DEA’s discretion by requiringdiscretion by requiring a specific findinga specific finding of “of “ imminent threat [of] imminent threat [of]
death, death, ~~serious~~ serious bodily harm, or abusebodily harm, or abuse of a controlled substance.” 21 U.S.C.of a controlled substance.” 21 U.S.C. § 824(d)(2); § 824(d)(2); see also Scott Higham & Lenny Scott Higham & Lenny
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controlled substances outside the usual course of professional practice without a legitimate controlled substances outside the usual course of professional practice without a legitimate
medical purpose in violation of state and federal controlled substances laws.medical purpose in violation of state and federal controlled substances laws.~~164~~
166 A violation of the CSA’s registration requirements—including failure to maintain records or A violation of the CSA’s registration requirements—including failure to maintain records or
detect and report suspicious orders, noncompliance with security requirements, or dispensing detect and report suspicious orders, noncompliance with security requirements, or dispensing
controlled substances without the necessary prescriptions—controlled substances without the necessary prescriptions—~~general y~~generally does not constitute a does not constitute a
criminal offense unless the violation is committed knowingly.criminal offense unless the violation is committed knowingly.~~165~~167 However, in the event of a However, in the event of a
knowing violation, DOJ may bring criminal charges against both individual and corporate knowing violation, DOJ may bring criminal charges against both individual and corporate
registrants. Potential penalties vary depending on the offense. For example, a first criminal registrants. Potential penalties vary depending on the offense. For example, a first criminal
violation of the registration requirements by an individualviolation of the registration requirements by an individual is punishable by a fine or up to a year is punishable by a fine or up to a year
in prison.in prison.~~166~~168 If “a registered manufacturer or distributor of opioids” commits knowing violations If “a registered manufacturer or distributor of opioids” commits knowing violations
such as failing to report suspicious orders for opioids or maintain effective controls against such as failing to report suspicious orders for opioids or maintain effective controls against
diversion of opioids, the registrant may be punished by a fine of up to $500,000 for each diversion of opioids, the registrant may be punished by a fine of up to $500,000 for each
registration violation.registration violation.~~167~~169
Trafficking Provisions
In addition to the registration requirements outlined above, the CSA contains provisions that In addition to the registration requirements outlined above, the CSA contains provisions that
define offenses involving the production, distribution, and possession of define offenses involving the production, distribution, and possession of ~~control ed~~controlled substances substances
outside the legitimateoutside the legitimate confines of the registration system—what this report refers to as the Act’s confines of the registration system—what this report refers to as the Act’s
trafficking provisions..~~168~~170 Although the word “trafficking” may primarily Although the word “trafficking” may primarily ~~cal~~ call to mind the to mind the ~~il egal~~illegal
distribution of recreational drugs, the CSA’s trafficking provisions in fact apply to a wide range distribution of recreational drugs, the CSA’s trafficking provisions in fact apply to a wide range
~~of il icit~~ of illicit activities involvingactivities involving either pharmaceutical or either pharmaceutical or ~~nonpharmaceutical~~non-pharmaceutical controlled substances. controlled substances.~~169~~171
Prohibitions
Key sections of the CSA’s trafficking provisions make the following activities Key sections of the CSA’s trafficking provisions make the following activities ~~il egal,~~ illegal, unless unless
otherwise authorized under the Act: otherwise authorized under the Act:
  Manufacture of a controlled substance, of a controlled substance,~~170~~172 which includes the synthesis of a which includes the synthesis of a ~~controlled~~
controlled substance that is a chemical, the cultivation of a controlled substance that is a plant, or substance that is a chemical, the cultivation of a controlled substance that is a plant, or
the processing or packaging of a controlled substance;the processing or packaging of a controlled substance;~~171~~

173 Bernstein, Bernstein, The Drug Industry’s ~~Trium ph~~Triumph over the DEA, WASH. POST, Oct. 15, 2017. , WASH. POST, Oct. 15, 2017.
~~164~~166 See Akhtar-Zaidi v. DEA, 841 F.3d 707, 710 (6th Cir. 2016). The court in Akhtar-Zaidi v. DEA, 841 F.3d 707, 710 (6th Cir. 2016). The court in Akhtar-Zaidi found that a physician found that a physician
violated federal and state lawviolated federal and state law “ “by (1) prescribing medication without patients’ addresses, (2) overstating the nature and by (1) prescribing medication without patients’ addresses, (2) overstating the nature and
extent of examinations conducted and pain levels reported by patients, and (3) failing to comply with state requirements extent of examinations conducted and pain levels reported by patients, and (3) failing to comply with state requirements
relating relating ~~t o~~to the treatment of chronic pain,” and thus “ the treatment of chronic pain,” and thus “ created a substantial likelihood that abuse of controlled substances created a substantial likelihood that abuse of controlled substances
wouldwould occur in the absence of an immediate suspension.” occur in the absence of an immediate suspension.” Id. at 710, 713. at 710, 713.
~~165~~167 21 U.S.C. 21 U.S.C. § 842(c)(1). § 842(c)(1).
~~166~~168 Id. § 842(c)(2)(A). § 842(c)(2)(A).
~~167~~169 Id. § 842(c)(2)(D). § 842(c)(2)(D).
~~168~~170 See id. §§ §§ 841-865. 841-865.
~~169~~171 See, e.g., , id. §§ §§ 841, 844 (criminalizing the manufacture, distribution, and possession of “a controlled substance,” 841, 844 (criminalizing the manufacture, distribution, and possession of “a controlled substance,”
except as authorized by the CSA). except as authorized by the CSA).
~~170~~172 Id. § 841(a)(1). § 841(a)(1).
~~171~~173 Id. §§§§ 802(15) (“‘manufacture’ means the production, preparation, propagation, compounding, or processing of a 802(15) (“‘manufacture’ means the production, preparation, propagation, compounding, or processing of a
drugdrug or other substance, either directly or indirectly or by extraction from substances ofor other substance, either directly or indirectly or by extraction from substances of natural origin, or independently natural origin, or independently
by means of chemical synthesis or byby means of chemical synthesis or by a combination of extraction and chemical synthesis, and includesa combination of extraction and chemical synthesis, and includes any packaging any packaging
or repackaging of suchor repackaging of such substance or labelingsubstance or labeling or relabeling of its containeror relabeling of its container ”); 802(22) (“”); 802(22) (“ ‘production’ includes the ‘production’ includes the
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  Distribution or or dispensing of a controlled substance; of a controlled substance;~~172~~174
  Possession of a controlled substance with or without intent to distribute. of a controlled substance with or without intent to distribute.~~173~~175
Penalties for the foregoing offenses vary based on the type and amount of the controlled Penalties for the foregoing offenses vary based on the type and amount of the controlled
substance in question.substance in question.~~174~~176 Other sections of the CSA define more specific offenses, such as Other sections of the CSA define more specific offenses, such as
distributing controlled substances at truck stops or rest areas,distributing controlled substances at truck stops or rest areas,~~175~~177 at schools, at schools,~~176~~178 or to people under or to people under
age 21;age 21;~~177~~179 endangering human life while manufacturing a controlled substance; endangering human life while manufacturing a controlled substance;~~178 sel ing~~180 selling drug drug
paraphernalia;paraphernalia;~~179~~181 and engaging in a “continuing criminal enterprise”—that is, an ongoing drug and engaging in a “continuing criminal enterprise”—that is, an ongoing drug
dealing operation that involves at least five other people and provides the defendant with dealing operation that involves at least five other people and provides the defendant with
substantial income or resources.substantial income or resources.~~180~~182 An attempt or conspiracy to commit any offense defined under An attempt or conspiracy to commit any offense defined under
the Act also constitutes a crime.the Act also constitutes a crime.~~181~~183
Enforcement and Penalties
DOJ enforces the CSA’s trafficking provisions by bringing criminal charges against DOJ enforces the CSA’s trafficking provisions by bringing criminal charges against ~~al eged~~alleged
violators.violators.~~182~~184 Notably, the CSA’s registration system and its trafficking regime are not Notably, the CSA’s registration system and its trafficking regime are not ~~mutual y~~
mutually exclusive, and participation in the registration system does not insulate registrants from the exclusive, and participation in the registration system does not insulate registrants from the
statute’s trafficking penalties. In statute’s trafficking penalties. In the 1975 case United States v. Moore, the Supreme Court rejected a claim that , the Supreme Court rejected a claim that
the CSAthe CSA “must be interpreted in light of a congressional intent to set up two separate and distinct “must be interpreted in light of a congressional intent to set up two separate and distinct
penalty systems,” one for registrants and one for persons not registered under the Act.penalty systems,” one for registrants and one for persons not registered under the Act.~~183~~185 The The
Court in Court in Moore held that physicians registered under the CSA can be prosecuted under the Act’s held that physicians registered under the CSA can be prosecuted under the Act’s
general drug trafficking provisions “when their activities general drug trafficking provisions “when their activities ~~fal~~ fall outside the usual course of outside the usual course of
professional practice.”professional practice.”~~184~~
186 Numerous judicial opinions provide guidance on what sorts of conduct Numerous judicial opinions provide guidance on what sorts of conduct ~~fal~~ fall outside the usual outside the usual
course of professional practice. The defendant in course of professional practice. The defendant in Moore was a registered doctor who distributed was a registered doctor who distributed
large amounts of methadone with inadequate patient exams and no precautions against misuse or large amounts of methadone with inadequate patient exams and no precautions against misuse or
diversion. The Court held that “[t]he evidence presented at trial was sufficient for the jury to find diversion. The Court held that “[t]he evidence presented at trial was sufficient for the jury to find
that respondent’s conduct exceeded the bounds of ‘professional practice’” because, “[i]n practical that respondent’s conduct exceeded the bounds of ‘professional practice’” because, “[i]n practical

manufacture, planting, cultivation, growing, or harvesting of a controlled substancemanufacture, planting, cultivation, growing, or harvesting of a controlled substance ”). ”).
~~172~~174 Id. § 841(a)(1). “Dispensing” refers to delivery of a controlled substance by a registered practitioner, including § 841(a)(1). “Dispensing” refers to delivery of a controlled substance by a registered practitioner, including
prescribing or administering a pharmaceutical controlled substance, whileprescribing or administering a pharmaceutical controlled substance, while “ “distribution” refers to other delivery of a distribution” refers to other delivery of a
controlled substance. controlled substance. Id. §§§§ 802(10), 802(11). 802(10), 802(11).
~~173~~ 175 Id. §§§§ 841(a)(1) (criminalizing 841(a)(1) (criminalizing ~~possess~~possession with intent to manufacture, distribute, or dispense, a controlled substance, with intent to manufacture, distribute, or dispense, a controlled substance,
except as except as ~~aut horized~~authorized under the Act); under the Act); id. § 844(a) (making it unlawful § 844(a) (making it unlawful “ “knowingly or intentionally to possess a knowingly or intentionally to possess a
controlled substance,” unlesscontrolled substance,” unless the substance wasthe substance was obtained in a manner authorized by the CSA).obtained in a manner authorized by the CSA).
~~174~~ 176 See, e.g., , id. §§ §§ 841(b). 841(b).
~~175~~177 Id. § 849. § 849.
~~176~~178 Id. § 860. § 860.
~~177~~179 Id. § 859. § 859.
~~178~~180 Id. § 858. § 858.
~~179~~181 Id. § 863. § 863.
~~180~~182 Id. § 848. § 848.
~~181~~183 Id. § 846. § 846.
~~182 T rafficking~~184 Trafficking that involves smuggling that involves smuggling may also implicate the Controlled Substancesmay also implicate the Controlled Substances Import and Export Act, 21 U.S.C. Import and Export Act, 21 U.S.C.
§§§§ 951-971, and/or the Maritime Drug Law951-971, and/or the Maritime Drug Law Enforcement Act, 46 U.S.C. §§Enforcement Act, 46 U.S.C. §§ ~~70501~~ 70501-70508. -70508.
~~183~~185 423 U.S. 122, 133 (1975). 423 U.S. 122, 133 (1975).
~~184~~186 Id. at 124. at 124.
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effect, he acted as a large-scale ‘pusher’—not as a physician.” effect, he acted as a large-scale ‘pusher’—not as a physician.”~~185 Appel ate~~187 Appellate courts have relied on courts have relied on
Moore to uphold convictions of a pharmacist who signed thousands of prescriptions for sale to uphold convictions of a pharmacist who signed thousands of prescriptions for sale
through an online through an online ~~pharmacy186~~pharmacy188 and a practitioner who “freely distributed prescriptions for large and a practitioner who “freely distributed prescriptions for large
amounts of controlled substances that are highly addictive, difficult to obtain, and sought after for amounts of controlled substances that are highly addictive, difficult to obtain, and sought after for
nonmedical purposes.”nonmedical purposes.”~~187 But~~189 However, several courts several courts ~~have~~ cautioned that a conviction under cautioned that a conviction under Moore
requires more than a showing of mere professional malpractice. For instance, the U.S. Court of requires more than a showing of mere professional malpractice. For instance, the U.S. Court of
Appeals for the Ninth Circuit (Ninth Circuit) has held that the prosecution must prove that the Appeals for the Ninth Circuit (Ninth Circuit) has held that the prosecution must prove that the
defendant “acted with intent to distribute the drugs defendant “acted with intent to distribute the drugs and with intent to distribute them outside the
course of professional practice,” suggesting that specific intent must be established with respect ,” suggesting that specific intent must be established with respect
to the defendant’s failure to abide by professional norms.to the defendant’s failure to abide by professional norms.~~188~~
~~For decades, DOJ has brought criminal trafficking charges against doctors and pharmacists who~~
~~dispensed pharmaceutical controlled substances outside the usual course of professional~~
~~practice.189 In April 2019, DOJ for the first time brought criminal trafficking charges against a~~
~~pharmaceutical company—Rochester Drug Cooperative—and two of its executives based on the~~
~~company’s sale of the opioids oxycodone and fentanyl to pharmacies that il egal y distributed the~~
~~drugs.190 Similarly, in July 2019, a federal grand jury indicted two former executives at the~~
~~pharmaceutical distributor Miami-Luken, Inc, among others, for conspiracy to violate the CSA’s~~
~~trafficking provisions.191~~
~~Violations of the CSA’s trafficking provisions are criminal offenses that may give rise to large~~
~~fines and significant prison time. Penalties vary according to the offense and may further vary~~
~~based on the type and amount of the controlled substance at issue. Unauthorized simple~~
~~possession of a controlled substance may prompt a minimum fine of $1,000 and a term of up to a~~
~~year in prison.192 Distribution of large quantities of certain drugs—including specific Schedule I~~
~~controlled substances such as heroin and LSD and specific Schedule II controlled substances such~~
~~as cocaine and methamphetamine—carries a prison sentence of 10 years to life and a fine of up to~~

~~185 Id. at 142-43.~~
~~186 See United States v. Nelson, 383 F.3d 1227, 1230 (10th Cir. 2004).~~
~~187 United States v. McIver, 470 F.3d 550, 564 (4th Cir. 2006).~~
~~188 United States v. Feingold,~~ 190 In the 2022 case Ruan v. United States, the Supreme Court clarified the mental state required to convict a medical practitioner for violation of the CSA’s trafficking provisions.191 The Court held that, “[a]fter a defendant produces evidence that he or she was authorized to dispense controlled substances”—that is, that he or she was registered to do so under the CSA—“the Government must prove beyond a reasonable doubt that the defendant knew that he or she was acting in an unauthorized manner, or intended to do so.”192 This means that the government must show that a CSA registrant knowingly or intentionally dispensed a controlled substance not for a legitimate medical purpose or in a manner that was not in the usual course of professional practice.193 For decades, DOJ has brought criminal trafficking charges against doctors and pharmacists who dispensed pharmaceutical controlled substances outside the usual course of professional practice.194 In April 2019, DOJ for the first time brought criminal trafficking charges against a pharmaceutical company—Rochester Drug Cooperative—and two of its executives based on the company’s sale of the opioids oxycodone and fentanyl to pharmacies that illegally distributed the drugs.195 Similarly, in July 2019, a federal grand jury indicted two former executives at the 187 Id. at 142-43. 188 See United States v. Nelson, 383 F.3d 1227, 1230 (10th Cir. 2004). 189 United States v. McIver, 470 F.3d 550, 564 (4th Cir. 2006). 190 United States v. Feingold, 454 F.3d 1001, 1008 (9th Cir. 2006) (emphasis in original); 454 F.3d 1001, 1008 (9th Cir. 2006) (emphasis in original); see also United States v. United States v.
Armstrong, 550 F.3d 382, 401 (5th Cir. 2008) (explaining that “Armstrong, 550 F.3d 382, 401 (5th Cir. 2008) (explaining that “ the the ~~m ens~~mens rea of a § of a § 841 offense is encompassed in the 841 offense is encompassed in the
second and third element of the crime—whether the practitioner intentionally dispensed second and third element of the crime—whether the practitioner intentionally dispensed ~~co ntrolled~~controlled substances substances without a without a
legitimate medical purpose or outside the scope of professional practice,” and distinguishinglegitimate medical purpose or outside the scope of professional practice,” and distinguishing “ “a § 841 prosecution from a § 841 prosecution from
a mere civil malpractice suit wherea mere civil malpractice suit where a plaintiff may prevail regardlessa plaintiff may prevail regardless of a defendant doctor’s good faith intent to act of a defendant doctor’s good faith intent to act
within the scope of medical practice”); United States v. Schneider, 704 F.3d 1287, 1295 (10th Cir. 2013) (approving within the scope of medical practice”); United States v. Schneider, 704 F.3d 1287, 1295 (10th Cir. 2013) (approving
jury instructions “jury instructions “ nearly identical” to those upheld in nearly identical” to those upheld in Feingold and holding that “ and holding that “ the jury, on the instructions given, the jury, on the instructions given,
found that [the defendant] knowingly acted not for a legitimate medical purpose or not within the usualfound that [the defendant] knowingly acted not for a legitimate medical purpose or not within the usual course of course of
professional practice”). professional practice”).
~~189~~191 142 S. Ct. 2370 (2022). 192 Id. at 2375. 193 Id. at 2382. 194 See, e.g., , Moore, 423 U.S. 122; Press Release,, 423 U.S. 122; Press Release, DEA, Multiple CasesDEA, Multiple Cases ~~Lead~~ Lead to Arrests of Five Doctors, One to Arrests of Five Doctors, One
Pharmacist, One Nurse Practitioner and Pharmacist, One Nurse Practitioner and ~~T hree~~Three Others (Oct. 11, 2018), https://www.dea.gov/press- Others (Oct. 11, 2018), https://www.dea.gov/press-
releases/2018/10/11/multiple-cases-lead-arrests-five-doctors-one-pharmacistreleases/2018/10/11/multiple-cases-lead-arrests-five-doctors-one-pharmacist -one-nurse; Press Release, DEA, DEA -one-nurse; Press Release, DEA, DEA
Large-scale Operation Large-scale Operation ~~T argets~~Targets 26 Pharmacies In 26 Pharmacies In ~~T hree~~Three States In Attack Against Illicit Opioid Abuse States In Attack Against Illicit Opioid Abuse ~~And T rafficking~~ And Trafficking
(Dec. 5, 2017), https://www.dea.gov/press-releases/2017/12/05/dea-large-scale-operation-targets-26-pharmacies-three-(Dec. 5, 2017), https://www.dea.gov/press-releases/2017/12/05/dea-large-scale-operation-targets-26-pharmacies-three-
states-attack. states-attack.
~~190~~ 195 See Press Release, DOJ, Press Release, DOJ, Manhattan U.S. Attorney And DEA Announce ChargesManhattan U.S. Attorney And DEA Announce Charges Against Rochester DrugAgainst Rochester Drug Co-Co-
Operative And Operative And ~~T wo~~Two Executives For Unlawfully Executives For Unlawfully ~~Distributing~~ Distributing Controlled SubstancesControlled Substances (Apr. 23, 2019), (Apr. 23, 2019),
https://www.justice.gov/usao-sdny/pr/manhattan-us-attorney-and-dea-announce-charges-againsthttps://www.justice.gov/usao-sdny/pr/manhattan-us-attorney-and-dea-announce-charges-against -rochester-drug-co--rochester-drug-co-
operative-and; operative-and; see also CRSCRS Legal SidebarLegal Sidebar LSB10307, LSB10307, Corporate Drug Trafficking Liability—a New Legal Front in
the Opioid Crisis,, by Joanna R. Lampe. In 2022, a federal jury convicted the company’s former CEO of conspiring to~~by Joanna R. Lampe.~~
~~191 See Indictment, United States v. Rattini, No. 19-cr-00081 (S.D. Ohio July 17, 2019).~~
~~192 21 U.S.C. § 844(a).~~
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~~$10 mil ion for an individual or a fine of up to $50 mil ion for an organization.193~~pharmaceutical distributor Miami-Luken, Inc., among others, for conspiracy to violate the CSA’s trafficking provisions.196 Violations of the CSA’s trafficking provisions are criminal offenses that may give rise to large fines and significant prison time. Penalties vary according to the offense and may further vary based on the type and amount of the controlled substance at issue. Unauthorized simple possession of a controlled substance may prompt a minimum fine of $1,000 and a term of up to a year in prison.197 Distribution of large quantities of certain drugs—including specific Schedule I controlled substances such as heroin and LSD and specific Schedule II controlled substances such as cocaine and methamphetamine—carries a prison sentence of 10 years to life and a fine of up to $10 million for an individual or a fine of up to $50 million for an organization.198 Penalties Penalties
increase for second or subsequent offenses, or if death or serious bodily injury results from the increase for second or subsequent offenses, or if death or serious bodily injury results from the
use of the controlled substance.use of the controlled substance.~~194~~199 Compared with the Compared with the civil penalties available for violations of the CSA’s registration provisions, the Act’s CSA’s registration provisions, the Act’s
criminal trafficking provisions trafficking provisions ~~general y~~generally entail greater potential liability—particularly entail greater potential liability—particularly for individual for individual
defendants—but also require prosecutors to show that a violation was intentional.defendants—but also require prosecutors to show that a violation was intentional.~~195~~200
The CSA is not the only means to target misconduct related to the distribution of pharmaceutical The CSA is not the only means to target misconduct related to the distribution of pharmaceutical
and and ~~nonpharmaceutical~~non-pharmaceutical controlled substances. Rather, such conduct can give rise to liability controlled substances. Rather, such conduct can give rise to liability under under
numerous other provisions of federal and state law. For example, drug companies may face numerous other provisions of federal and state law. For example, drug companies may face
administrative sanctions or criminal charges under the FD&C Act.administrative sanctions or criminal charges under the FD&C Act.~~196~~201 Companies and individuals Companies and individuals
may also be subject to federal criminal charges under the Racketeer Influenced and Corrupt may also be subject to federal criminal charges under the Racketeer Influenced and Corrupt
Organizations Organizations ~~Act197~~Act202 or the Federal Anti-Kickback Statute. or the Federal Anti-Kickback Statute.~~198~~203 Those statutes notably formed part Those statutes notably formed part
of the basis for the significant settlement between DOJ and opioid manufacturer Purdue Pharma of the basis for the significant settlement between DOJ and opioid manufacturer Purdue Pharma
in 2020.in 2020.~~199~~204 And manufacturers and distributors of opioids currently face numerous civil suits distribute unlawfully oxycodone and fentanyl and conspiring to defraud DEA. Press Release, DOJ, Laurence Doud, Former CEO Of Pharmaceutical Distributor, Convicted Of Conspiring To Distribute Controlled Substances And Defrauding The DEA (Feb. 2, 2022), https://www.justice.gov/usao-sdny/pr/laurence-doud-former-ceo-pharmaceutical-distributor-convicted-conspiring-distribute. 196 See Indictment, United States v. Rattini, No. 19-cr-00081 (S.D. Ohio July 17, 2019). DOJ dropped the charges against Miami-Luken and its executives following the Supreme Court’s decision in Ruan. See Order Granting Mot. Dismiss, United States v. Rattini, No. 19-cr-00081 (S.D. Ohio Aug. 11, 2022). 197 21 U.S.C. § 844(a). 198 Id. § 841(b)(1)(A). 199 Id. § 841(b). 200 A civil violation of the CSA’s recordkeeping and reporting requirements requires only a showing ~~And manufacturers and distributors of opioids currently face numerous civil suits~~
~~under federal and state law based on the companies’ marketing and distribution of prescription~~
~~opioids.200~~
~~Legal Considerations for the 117th Congress~~
~~Drug regulation has received significant attention from Congress in recent years, prompting a~~
~~range of proposals concerning the opioid epidemic; the proliferation of synthetic drugs, in~~
~~particular analogues to the opioid fentanyl; the divergence between the status of marijuana under~~
~~state and federal law; the ability of researchers to conduct clinical research involving Schedule I~~
~~controlled substances; and the response to the COVID-19 pandemic.~~
~~Opioid Crisis~~
~~One salient current issue in the realm of control ed substance regulation is the opioid epidemic.~~
~~Opioids are drugs derived from the opium poppy or emulating the effects of opium-derived~~

~~193 Id. § 841(b)(1)(A).~~
~~194 Id. § 841(b).~~
~~195 A violation of the CSA’s recordkeeping and reporting requirements requires only a showing~~ of negligence. of negligence. See 21 21
~~U.S.C. § 842. By contrast, a~~U.S.C. § 842(a)(5). A violation of Section 842 may be a crime punishable by a fine and not more than a year in prison if “prosecuted by an information or indictment which alleges that the violation was committed knowingly and the trier of fact specifically finds that the violation was so committed.” Id. § 842(c)(2)(A). A violation of the CSA’s trafficking violation of the CSA’s trafficking ~~provision s~~provisions must be must be committed “committed “ knowingly or knowingly or
intentionally,” with corporations subject to liability “basedintentionally,” with corporations subject to liability “based on the ‘knowledge and intent’ of their employees.” United on the ‘knowledge and intent’ of their employees.” United
States v. Philip Morris USAStates v. Philip Morris USA Inc., 566 F.3d 1095, 1118 (D.C. Cir. 2009); Inc., 566 F.3d 1095, 1118 (D.C. Cir. 2009); see also 21 U.S.C. 21 U.S.C. § § 841. 841.
~~196~~ 201 See, e.g., , id. § § 333; see also CRS333; see also CRS Report R43609, Report R43609, Enforcement of the Food, Drug, and Cosmetic Act: Select Legal
Issues, by Jennifer A. Staman. , by Jennifer A. Staman.
~~197~~202 See, e.g., Press Release,, Press Release, DOJ, FounderDOJ, Founder and Owner of Pharmaceutical Company Insys Arrested and Chargedand Owner of Pharmaceutical Company Insys Arrested and Charged with with
Racketeering (Oct. 26, 2017); Gabrielle Emmanuel and Katie Racketeering (Oct. 26, 2017); Gabrielle Emmanuel and Katie ~~T homas~~Thomas, , Opioid ~~Com pany~~Company Executives Convicted of
Racketeering, N.Y. , N.Y. ~~T IMES~~TIMES, May 3, 2019, at B1. , May 3, 2019, at B1.
~~198~~203 See, e.g., Press Release,, Press Release, DOJ, JusticeDOJ, Justice Department Announces Global Resolution of Criminal and Civil Department Announces Global Resolution of Criminal and Civil
Investigations with Opioid Manufacturer PurdueInvestigations with Opioid Manufacturer Purdue Pharma and Civil Settlement with Members of the Sackler Family Pharma and Civil Settlement with Members of the Sackler Family
(Oct. 21, 2020). (Oct. 21, 2020).
~~199~~ 204 Purdue Pharma LP Purdue Pharma LP ~~plead~~pled guilty to violating the Federal Anti-Kickback Statute and conspiracy to defraud the United guilty to violating the Federal Anti-Kickback Statute and conspiracy to defraud the United
States; the company and its shareholders also settled civil claims brought by the United States. See id.
~~200 See, e.g., National Prescription Opiate Litigation, No. 17-MD-2804 (N.D. Ohio Dec. 12, 2017); see also CRS Legal~~
~~Sidebar LSB10365, Overview of the Opioid Litigation and Related S ettlem ents and Settlem ent Proposals, by Wen W.~~
~~Shen; CRS Legal Sidebar LSB10226, State and Local Governm ents Pursue Judicial Solutions to the Opioid Epidem ic ,~~
~~by Jennifer A. Staman.~~
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~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~drugs.201~~ Congressional Research Service 21 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress under federal and state law based on the companies’ marketing and distribution of prescription opioids.205 Legal Considerations for the 118th Congress Drug regulation has received significant attention from Congress in recent years. The opioid epidemic and various federal, state, and local efforts to respond to the crisis have raised a number of legal and policy questions, including how to regulate synthetic opioids related to fentanyl and whether supervised injection sites should be allowed under the CSA. In addition, policymakers have confronted a growing divergence between the status of marijuana under state and federal law, considered whether and how to facilitate clinical research involving Schedule I controlled substances, proposed legislation that would expand access to controlled substances via telemedicine, and debated reforms to criminal sentences for controlled substance offenses involving cocaine. The remainder of this report focuses on these and other particular topics that may be of interest to the 118th Congress. Opioid Epidemic One salient current issue in the realm of controlled substance regulation is the opioid epidemic.206 Opioids are drugs derived from the opium poppy or emulating the effects of opium-derived drugs.207 Some opioids have legitimate medical purposes, primarily related to pain management, Some opioids have legitimate medical purposes, primarily related to pain management,
while others have no recognized medical use.while others have no recognized medical use.~~202~~208 Both pharmaceutical opioids (such as Both pharmaceutical opioids (such as
oxycodone, codeine, and morphine) and oxycodone, codeine, and morphine) and ~~nonpharmaceutical~~non-pharmaceutical opioids (such as heroin) may pose a opioids (such as heroin) may pose a
risk of abuse and dependence and may be dangerous or even deadly inrisk of abuse and dependence and may be dangerous or even deadly in ~~excessive~~ certain doses. doses.~~203~~209 The The
CDC reports that overdoses CDC reports that overdoses ~~of prescription and nonprescription~~involving opioids claimed over opioids claimed over ~~50,000~~80,800 lives lives
~~in 2019.204~~in 2021.210 CDC researchers further estimate that the CDC researchers further estimate that the ~~misuse of prescription opioids alone cost the~~
~~United States $78.5 bil ion in 2013.205~~
costs of opioid use disorder and fatal opioid overdoses exceeded $1 trillion in 2017.211 In recent years, the opioid crisis has prompted various legislative proposals aiming to prevent the In recent years, the opioid crisis has prompted various legislative proposals aiming to prevent the
~~il icit~~ illicit distribution of opioids; curb the effects of the crisis on individuals, families, and distribution of opioids; curb the effects of the crisis on individuals, families, and
communities; and cover the costs of law enforcement efforts and treatment programs. In 2016, communities; and cover the costs of law enforcement efforts and treatment programs. In 2016,
States; the company and its shareholders also settled civil claims brought by the United States. See id. 205 See, e.g., National Prescription Opiate Litigation, No. 17-MD-2804 (N.D. Ohio Dec. 12, 2017); see also CRS Legal Sidebar LSB10365, Overview of the Opioid Litigation and Related Settlements and Settlement Proposals, by Wen W. Shen; CRS Legal Sidebar LSB10226, State and Local Governments Pursue Judicial Solutions to the Opioid Epidemic, by Jennifer A. Staman. 206 For a brief overview of legal and policy issues related to the opioid epidemic, see CRS In Focus IF12260, The Opioid Crisis in the United States: A Brief History, by Johnathan H. Duff et al. 207 See CRS Report R44987, The Opioid Epidemic and Federal Efforts to Address It: Frequently Asked Questions, by Lisa N. Sacco and Erin Bagalman. Technically, the term “opiates” refers to natural compounds found in the opium poppy, while the term “opioids” refers to synthetic compounds that emulate the effects of opiates, but commentators often use the term “opioids” to refer to both categories of substances, and this report adopts that usage. See id. 208 Id. 209 Id. 210 See CDC, U.S. Overdose Deaths In 2021 Increased Half as Much as in 2020 – But Are Still Up 15% (May 11, 2022), https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/202205.htm. 211 See Curtis S. Florence, et al., The Economic Burden of Opioid Use Disorder and Fatal Opioid Overdose in the United States, 2017, 218 DRUG & ALCOHOL DEPENDENCE (Jan. 2021). Congressional Research Service 22 link to page 12 link to page 27 link to page 20 link to page 18 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress Congress enacted the Comprehensive Addiction and Recovery Act of 2016 (CARA)212~~Congress enacted the Comprehensive Addiction and Recovery Act of 2016 (CARA)206~~ and the and the
21st Century Cures Act (Cures Act).21st Century Cures Act (Cures Act).~~207~~213 CARA authorized grants to address CARA authorized grants to address ~~the opioid crisis in~~
~~areas~~issues related to the opioid crisis including abuse prevention and education, law enforcement, and treatment including abuse prevention and education, law enforcement, and treatment~~, while the~~ .214 The Cures Cures
Act, among other things, provided additional funding to states combating opioid addiction.Act, among other things, provided additional funding to states combating opioid addiction.~~208~~215 In In
2018, Congress enacted the Substance Use-Disorder Prevention that Promotes Opioid Recovery 2018, Congress enacted the Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act (SUPPORT Act), which sought to address the and Treatment for Patients and Communities Act (SUPPORT Act), which sought to address the
opioid crisis through far-ranging amendments to the CSA, the FD&C Act, and other statutes.opioid crisis through far-ranging amendments to the CSA, the FD&C Act, and other statutes.~~209~~
216 Key amendments to the CSA under the SUPPORT Act included provisions expanding access to Key amendments to the CSA under the SUPPORT Act included provisions expanding access to
medication-assisted treatment for opioid addiction,medication-assisted treatment for opioid addiction,~~210~~217 specifying the factors for determining specifying the factors for determining
whether a controlled substance analogue is intended for human consumption,whether a controlled substance analogue is intended for human consumption,~~211~~ 218 revising the revising the
factors DEA considers when establishing opioid production quotas,factors DEA considers when establishing opioid production quotas,~~212~~219 and codifying the and codifying the
definition of “suspicious order” and outlining the CSA’s suspicious order reporting definition of “suspicious order” and outlining the CSA’s suspicious order reporting
~~requirements.213~~

~~201 See CRS Report R44987, The Opioid Epidemic and Federal Efforts to Address It: Frequently Asked Questions, by~~
~~Lisa N. Sacco and Erin Bagalman. T echnically, the term “ opiates” refers to natural compounds found in the opium~~
~~poppy, while the term “ opioids” refers to synthetic compounds that emulate the effects of opiates, but commentators~~
often use the term “opioids” to refer to both categories of substances, and this report adopts that usage. See id.
202 Id.
203 Id.
~~204 See American Hospital Association, CDC: Drug overdose deaths up 4.6% in 2019 (July 16, 2020),~~
~~https://www.aha.org/news/headline/2020-07-16-cdc-drug-overdose-deaths-46-2019.~~
~~205 See Curtis S. Florence, et al.,~~ ~~The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in~~
~~the United States, 2013, 54 MEDICAL CARE 901 (2016).~~
~~206 Pub. L. No. 114-198, 130 Stat. 695 (2016).~~
~~207 Pub. L. No. 114-255, 130 Stat. 1033 (2016).~~
208 See ~~CRS~~ requirements.220 Building on these far-reaching enactments, the 116th and 117th Congresses enacted legislation seeking to address specific facets of the opioid crisis. Some of that legislation is discussed in the following subsections, along with selected recent proposals for reform. Fentanyl Analogues One issue that garnered significant attention in the 116th and 117th Congresses is the proliferation of synthetic drugs, especially synthetic opioids. In contrast to drugs derived from natural materials such as plants, synthetic drugs are drugs that are chemically produced in a laboratory; they may have the same chemical structure as an existing natural drug or mimic the effects of an existing drug using a different chemical structure.221 Many legal pharmaceutical drugs are synthetically produced.222 On the other hand, clandestine actors seeking to circumvent existing drug laws often design synthetic drugs that mimic the effects of other drugs—or even produce similar but stronger effects—but have chemical structures that have been slightly modified to circumvent existing drug laws.223 212 P.L. 114-198, 130 Stat. 695 (2016). 213 P.L. 114-255, 130 Stat. 1033 (2016). 214 See CRS Report R45449, Report R45449, The SUPPORT for Patients and Communities Act (P.L.115-271): Medicare Provisions, ,
coordinated by Suzannecoordinated by Suzanne M. Kirchhoff. M. Kirchhoff.
~~209 Pub. L. No~~ 215 See id. 216 P.L. 115-271, 132 Stat. 3894 (2018); . 115-271, 132 Stat. 3894 (2018); see also CRS CRS Report R45449, Report R45449, The SUPPORT for Patients and
~~Com m unities~~ Communities Act (P.L.115-271): Medicare Provisions, coordinated by Suzanne, coordinated by Suzanne M. Kirchhoff; CRSM. Kirchhoff; CRS Report R45423, Report R45423,
Public Health and Other Related Provisions in P.L 115 -271, the SUPPORT for Patients and ~~Com m unities~~Communities Act, ,
coordinated by Elayne J. Heisler and Johnathan H. Duffcoordinated by Elayne J. Heisler and Johnathan H. Duff ; CRS; CRS Report R45405, Report R45405, The SUPPORT for Patients and
~~Com m unities~~Communities Act (P.L. 115-271): Food and Drug ~~Adm inistration~~Administration and Controlled ~~Substan ce~~Substance Provisions, coordinated by , coordinated by
Agata Bodie. Agata Bodie.
~~210 Pub. L. No~~217 P.L. 115-271, §§ 3201-04. . 115-271, §§ 3201-04.
~~211 Id. § 3241.~~
~~212 Id. § 3282.~~
~~213 Id. §§ 3291-92.~~
~~Congressional Research Service~~
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~~link to page 26~~ ~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~Notwithstanding the flurry of recent legal changes, numerous legislative proposals in the 116th~~
~~Congress sought to address the opioid crisis by further amending the CSA.214 For example, the~~
~~DEA Enforcement Authority Act of 2019215 would have made it easier for DEA to suspend a~~
~~registration. Specifical y, the bil would have lowered the threshold for what constitutes imminent~~
~~danger, al owing suspension upon a finding of “probable cause that death, serious bodily harm, or~~
~~abuse of a controlled substance wil occur in the absence of an immediate suspension of the~~
registration,” rather than the current statutory requirement of “a substantial likelihood of an
immediate threat that death, serious bodily harm, or abuse of a controlled substance wil occur in
~~the absence of an immediate suspension of the registration.”216 In addition, the John S. McCain~~
~~Opioid Addiction Prevention Act217 would have required medical practitioners applying for new~~
~~or renewed CSA registration to certify that they wil not prescribe more than a seven-day supply~~
~~of opioids for the treatment of acute pain.218 The LABEL Opioids Act219 would have amended the~~
~~CSA to require that opioids in Schedules II through V bear labels warning that they can cause~~
~~dependence, addiction, and overdose. Failure to comply with the labeling requirements would~~
~~have violated the CSA’s registration requirements.220 Other proposals sought to improve~~
~~treatment of opioid use disorder.221~~
~~Some proposals targeted specific opioids, especial y fentanyl.222 Fentanyl is a powerful opioid~~
~~that has legitimate medical uses such as pain management for cancer patients and patients on~~
~~ventilators.223 But, due to its potency, it also poses a particularly high risk of abuse, dependency,~~

~~214 Numerous additional proposals to address the opioid epidemic fall outside the scope of this report. For instance,~~
~~some proposals would amend the FD&C Act to increase liability for pharmaceutical companies or executives that~~
~~violate the FD&C Act. See, e.g., Opioid Crisis Accountability Act, S. 1584, 116th Cong. (2019). Others would provide~~
~~additional funding for local law enforcement efforts, opioid dependence treatment, or other related initiatives. See, e.g.,~~
~~Opioid T reatment Surge Act, S. 1662, 116th Cong. (2019); Budgeting for Opioid Addiction T reatment Act, S. 425,~~
~~116th Cong. (2019).~~
~~215 S. 424, 116th Cong. (2019).~~
~~216 Compare id. with 21 U.S.C. § 824(d)(2). For brief discussion of several additional bills from the 116th Congress that~~
~~would have altered the CSA’s registration requirements in an effort to combat the opioid crisis, see Emily Field,~~ ~~House~~
~~Passes Bipartisan Bills To Fight Opioid Crisis, Law360, Nov. 17, 2020.~~
~~217 H.R. 1614, 116th Cong. (2019); S. 724, 116th Cong. (2019).~~
~~218 T he bill includes exceptions for other types of treatment including management of chronic pain, end-of-life care,~~
~~and treatment of addiction.~~
~~219 H.R. 2732, 116th Cong. (2019); S. 1449, 116th Cong. (2019).~~
~~220 See 21 U.S.C. § 842(a)(4) (providing that it is unlawful “ to remove, alter, or obliterate a symbol or label required~~
~~by” the CSA).~~
~~221 See Strengthening Medicaid Coverage of MAT Act, S. 4674, 116th Cong. (2020) (clarifying that drugs and~~
~~biologicals used for medication-assisted treatment under Medicaid are subject to the requirements of the Medicaid~~
~~Drug Rebate Program); MAT E Act of 2020, S. 4640, 116th Cong. (2020) (requiring physicians and other prescribers of~~
~~controlled substances to complete training on treating and managing patients with opioid and other substance use~~
~~disorders); Easy MAT for Opioid Addiction Act, H.R. 2281, 116th Cong. (2019) (direct ing the Attorney General to~~
~~amend certain regulations so that practitioners may administer not more than 3 days’ medication to a person at one time~~
~~when administering narcotic drugs for the purpose of relieving acute withdrawal symptoms). T he Easy MAT for~~
~~Opioid Addiction Act passed the House on November 17, 2020. “ MAT ” stands for “ m edication-assisted treatment” and~~
~~refers to the combined use of medication and other services to treat addiction . See CRS In Focus IF10219,~~ ~~Opioid~~
~~Treatm ent Program s and Related Federal Regulations, by Johnathan H. Duff.~~
~~222 For additional discussion of fentanyl regulation, see infra “Analogue Fentanyl.”~~
~~223 See id.; CRS Insight IN11321, COVID-19: The Drug Enforcement Administration’s Regulatory Role, by Lisa N.~~
~~Sacco.~~
~~Congressional Research Service~~
22

~~link to page 13~~ ~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~and overdose.224 The Ending the Fentanyl Crisis Act of 2019225 would have amended the CSA to~~
~~reduce the amounts of fentanyl required to constitute a trafficking offense.226 That bil would have~~
~~also increased penalties applicable to offenses involving fentanyl and provided separate~~
~~procedures for emergency scheduling of synthetic opioids.227 The Screening Al Fentanyl-~~
~~Enhanced Mail Act of 2019228 sought to require screening of al inbound international mail and~~
~~express cargo from high-risk countries to detect and prevent the importation of il icit fentanyl and~~
~~other synthetic opioids. Final y, the Blocking Deadly Fentanyl Imports Act229 aimed to gather~~
~~information about the production of il icit fentanyl in foreign countries and to withhold bilateral~~
~~assistance from countries that fail to enforce certain controlled substance regulations.~~
~~Analogue Fentanyl~~
~~A related issue that garnered significant attention in the 116th Congress is the proliferation of~~
~~synthetic drugs, especial y synthetic opioids. In contrast to drugs derived from natural materials~~
~~such as plants, synthetic drugs are drugs that are chemical y produced in a laboratory; they may~~
~~have the same chemical structure as an existing natural drug or mimic the effects of an existing~~
~~drug using a different chemical structure.230 Many legal pharmaceutical drugs are synthetical y~~
~~produced.231 On the other hand, clandestine actors seeking to circumvent existing drug laws often~~
~~design synthetic drugs to mimic the effects of other drugs—or even produce similar but stronger~~
~~effects—but have chemical structures that have been slightly modified to circumvent existing~~
~~drug laws.232~~
~~One particular concern in this area relates to synthetic opioids, including fentanyl analogues and~~
~~other fentanyl-like substances. Prescription fentanyl is a Schedule II controlled substance;~~
~~multiple nonpharmaceutical substances related to fentanyl are controlled in Schedule I.233~~
~~However, experts have noted that it is relatively easy to manipulate the chemical structure of~~
~~fentanyl in order to produce new substances that are not included in the CSA’s schedules but may~~
~~have similar effects to fentanyl or pose other dangers if consumed.234 Since March 2011, DEA has~~

~~224 See DEA, Schedules of Controlled Substances: T emporary Placement of Fentanyl-Related Substances in Schedule I,~~
~~83 Fed. Reg. 5188, 5188-90 (Feb. 6, 2018).~~
~~225 S. 1724, 116th Cong. (2019).~~
~~226 T he Comprehensive Fentanyl Control Act, introduced in the 115th Congress, would likewise have reduced the~~
~~amount of fentanyl triggering criminal liability. See H.R. 1781, 115th Cong. (2017).~~
~~227 T he Comprehensive Fentanyl Control Act would have allowed for temporary scheduling of a substance if the DEA~~
~~Administrator found that “ the drug or other substance satisfies the criteria for being considered a synthetic opioid” and~~
~~“adding such drug or other substance to the definition of synthetic opioids will assist in preventing abuse or misuse of~~
~~the drug or other substance.” S. 1724, 116th Cong. (2019). For discussion of the current requirements for emergency~~
~~scheduling, see supra “ Emergency Scheduling.”~~
~~228 H.R. 4102, 116th Cong. (2019); S. 2323, 116th Cong. (2019).~~
~~229 H.R. 1098, 116th Cong. (2019); S. 400, 116th Cong. (2019).~~
~~230 See CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea.~~
~~231 See, e.g., Kevin R. Campos, et al., The Importance of Synthetic Chemistry in the Pharmaceutical Industry, SCIENCE,~~
~~Jan. 18, 2019.~~
~~232 Synthetic drugs that slightly modify the molecular structures of controlled substances to circumvent existing drug~~
~~laws may also be called “ designer drugs.” See CRS Report R42066,~~ ~~Synthetic Drugs: Overview and Issues for~~
~~Congress, by Lisa N. Sacco and Kristin Finklea.~~
~~233 See 21 C.F.R. §§ 1308.11, 1308.12.~~
~~234 See CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea.~~
~~Congressional Research Service~~
23

~~link to page 13 link to page 10 link to page 6 link to page 6 link to page 6 link to page 27~~ ~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~used its emergency scheduling authority235 to impose temporary controls on 74 synthetic drugs,~~
~~including 17 fentanyl-like substances.236~~
~~Even if not individual y scheduled under the CSA, fentanyl-like substances may be subject to~~
~~DEA control as controlled substance analogues.237 However, analogue controlled substance~~
~~prosecutions can be burdensome because they raise “complex chemical and scientific issues.”238~~
~~That is because liability for trafficking in controlled substance analogues requires proof that the~~
~~substance at issue (1) is intended for human consumption and (2) has either a chemical structure~~
~~substantial y similar to the chemical structure of a Schedule I or II control ed substance or an~~
~~actual or intended effect similar to or greater than that of a Schedule I or II controlled~~
~~substance.239 If fentanyl analogues were explicitly scheduled, proof of those additional elements~~
~~would not be necessary. Moreover, some synthetic drugs do not meet the applicable criteria to be~~
~~deemed controlled substance analogues—for example, because their effects are unpredictable or~~
~~because they replicate the effects of more than one class of drugs.240 DOJ has therefore argued~~
~~that permanent scheduling of fentanyl analogues can reduce uncertainty and aid enforcement.241~~
~~A key chal enge in permanently scheduling fentanyl analogues is how to define the substances~~
~~subject to regulation. Not al analogues of fentanyl have effects similar to fentanyl itself, and due~~
~~to the large number of potential analogues there are many whose effects are unknown.242 On one~~
~~hand, defining covered substances based on chemical structure may be overinclusive because the~~
~~definition may include inactive substances, potential y al owing~~For additional information on medication-assisted treatment for opioid use disorder, see CRS In Focus IF10219, Opioid Treatment Programs and Related Federal Regulations, by Johnathan H. Duff. 218 P.L. 115-271, § 3241. The question of whether a substance is intended for human consumption is relevant to controlled substance analogue prosecutions. See supra “Analogues and Listed Chemicals”; infra “Fentanyl Analogues.” 219 P.L. 115-271, § 3282. See also supra “Quotas.” 220 P.L. 115-271, §§ 3291-92. See also supra “Recordkeeping and Reporting.” 221 See CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea. 222 See, e.g., Kevin R. Campos, et al., The Importance of Synthetic Chemistry in the Pharmaceutical Industry, SCIENCE, Jan. 18, 2019. 223 Synthetic drugs that slightly modify the molecular structures of controlled substances to circumvent existing drug Congressional Research Service 23 link to page 15 link to page 12 link to page 7 link to page 7 link to page 7 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress One particular public concern in this area relates to synthetic opioids, including fentanyl analogues.224 Prescription fentanyl is a Schedule II controlled substance; multiple non-pharmaceutical substances related to fentanyl are controlled in Schedule I.225 However, it is relatively easy to manipulate the chemical structure of fentanyl in order to produce new substances that may have similar effects to fentanyl or pose other dangers if consumed.226 DEA has stated that, between March 2011 and January 2020, the agency used its emergency scheduling authority227 to impose temporary controls on 74 synthetic drugs, including 17 fentanyl-like substances.228 Even if not individually scheduled under the CSA, substances related to fentanyl may be subject to DEA control as controlled substance analogues.229 However, DOJ has stated that analogue prosecutions can be burdensome because they raise “complex chemical and scientific issues.”230 That is because liability for trafficking in controlled substance analogues requires proof that the substance at issue (1) is intended for human consumption and (2) has either a chemical structure substantially similar to the chemical structure of a Schedule I or II controlled substance or an actual or intended effect similar to or greater than that of a Schedule I or II controlled substance.231 For fentanyl analogues that are explicitly scheduled, proof of those additional elements is not necessary. Moreover, some synthetic drugs do not meet the applicable criteria to be deemed controlled substance analogues—for example, because their effects are unpredictable or because they replicate the effects of more than one class of drugs.232 DOJ has therefore argued that permanent scheduling of fentanyl analogues can reduce uncertainty and aid enforcement.233 The 116th and 117th Congresses did not permanently schedule fentanyl analogues, but they did enact legislation to facilitate DEA’s regulation of those substances. In February 2018, DEA issued an emergency scheduling order (Fentanyl TSO) that temporarily placed in Schedule I a class of “fentanyl-related substances.”234 While previous scheduling actions by DEA and Congress generally identified a specific substance or a list of discrete substances for control, the Fentanyl TSO instead imposed controls on a large class of fentanyl-related substances that met specific criteria related to their chemical structures. That class of substances is finite, but it laws may also be called “designer drugs.” See CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea. 224 See, e.g., Press Release, U.S. Atty. Robert J. Higdon, Jr., et al., Congress Must Ban Fentanyl Analogues (Jan. 30, 2020), https://www.justice.gov/usao-wdnc/pr/congress-must-ban-fentanyl-analogues. 225 See 21 C.F.R. §§ 1308.11, 1308.12. 226 See CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea. 227 See supra “Emergency Scheduling.” 228 See Fentanyl Analogues: Perspectives on Classwide Scheduling: Hearing Before the House Comm. on the Judiciary, 116th Cong. 2 (2020) (statement of the U.S. Dep’t of Justice). Since January 2020, DEA has used its emergency scheduling authority to control additional synthetic opioids. See DEA, Schedules of Controlled Substances: Temporary Placement of Isotonitazene in Schedule I, 85 Fed. Reg. 51,342 (Aug. 20, 2020); DEA, Schedules of Controlled Substances: Temporary Placement of Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene, Metonitazene, N-Pyrrolidino etonitazene, and Protonitazene in Schedule I, 87 Fed. Reg. 21,556 (Apr. 12, 2022). 229 See supra “Analogues and Listed Chemicals.” 230 DOJ Testimony, supra note 34 at 5. 231 21 U.S.C. §§ 802(32), 813; see also DOJ Testimony, supra note 34 at 5. 232 See CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea. 233 DOJ Testimony, supra note 34 at 5. 234 DEA, Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I, 83 Fed. Reg. 5188 (Feb. 6, 2018). The emergency scheduling order applies to “any substance not otherwise [subject to the CSA] that is structurally related to fentanyl by one or more [specified] modifications.” Id. at 5191-92. Congressional Research Service 24 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress includes thousands of chemicals.235 As one researcher testified before Congress, the effects, potential for abuse and dependence, and medical utility of many of those substances are unknown.236 Perhaps because of those uncertainties, DEA did not initiate permanent scheduling of the class of substances subject to the Fentanyl TSO,237 though the agency has continued to take temporary and permanent scheduling actions with respect to specific fentanyl analogues, including selected fentanyl-related substances subject to the Fentanyl TSO.238 The Fentanyl TSO was set to expire in February 2020.239 On February 6, 2020, Congress enacted the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act, which extended temporary scheduling of the class of fentanyl-related substances until May 6, 2021.240 Congress has since extended the temporary scheduling several times, most recently through December 31, 2024.241 Absent further legislative or administrative action, substances subject to the Fentanyl TSO will remain in Schedule I and subject to all restrictions and penalties applicable to Schedule I substances until the December 2024 expiration date. After the expiration date, the class of substances will no longer be scheduled under the CSA but may still be subject to control as controlled substance analogues. As noted, fentanyl itself and certain specific related chemicals are permanently controlled in Schedules I and II.242 The Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act and subsequent legislation extending the temporary scheduling do not affect those classifications. Multiple proposals in the 116th and 117th Congresses sought to permanently schedule fentanyl analogues. Some of the proposals would have permanently placed the class of substances subject to the Fentanyl TSO in Schedule I.243 Others would have scheduled the class of fentanyl-related substances subject to the Fentanyl TSO plus certain specific substances.244 235 The Countdown: Fentanyl Analogues & the Expiring Emergency Scheduling Order: Hearing Before the Sen. Comm. on the Judiciary, 116th Cong. 2 (2019) (statement of Kemp L. Chester). 236 See Fentanyl Analogues: Perspectives on Classwide Scheduling: Hearing Before the House Comm. on the Judiciary, 116th Cong. 4 (2020) (statement of Sandra D. Comer). 237 By statute, DEA rulemaking permanently scheduling a controlled substance must be supported by certain factual findings. See 21 U.S.C. § 811(c). January 2020 testimony from an HHS official indicated that, given the large number of substances subject to the order, it was not feasible to make the individualized findings required to schedule each substance permanently. Fentanyl Analogues: Perspectives on Classwide Scheduling: Hearing Before the House Comm. on the Judiciary, 116th Cong. 4 (2020) (statement of Brett P. Giroir). Congress is not required to make the same findings to schedule a substance via legislation. 238 See DEA, Schedules of Controlled Substances: Placement of Four Specific Fentanyl-Related Substances in Schedule I, 86 Fed. Reg. 14,707 (Mar. 18, 2021). 239 DEA, Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I, 83 Fed. Reg. 5188, 5188 (Feb. 6, 2018). 240 P.L. 116-114, 134 Stat. 103 (2020). For further discussion of the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act, see CRS Legal Sidebar LSB10404, An Expiration Date for Temporary Control of Fentanyl Analogues, by Joanna R. Lampe. 241 P.L. 117-328, div. O, § 601. 242 See 21 C.F.R. §§ 1308.11, 1308.12. 243 See, e.g., Protecting Americans from Fentanyl Trafficking Act of 2022, S. 3457, 117th Cong. (2022); CEASE Overdose Act of 2022, H.R. 6713, 117th Cong. (2022); Federal Initiative To Guarantee Health by Targeting Fentanyl Act, H.R. 1910, 117th Cong. (2021); see also Zero Tolerance for Deceptive Fentanyl Trafficking Act, S. 3342, 116th Cong. (2020) (would have permanently added “fentanyl-related substances” to Schedule I and imposed criminal penalties for knowingly misrepresenting or knowingly marketing as another substance a mixture or substance containing fentanyl, a fentanyl analogue, or a fentanyl-related substance). 244 See, e.g., Stopping Overdoses of Fentanyl Analogues Act, H.R. 2209, 117th Cong. (2021); S. 1006. 117th Cong. Congressional Research Service 25 link to page 28 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress Some proposals also sought to address specific concerns related to class-wide scheduling. Because the effects of some of the substances subject to the Fentanyl TSO are currently unknown, it is possible that some might have legitimate medical uses or pose little or no risk of abuse and dependence. Thus, some legislative proposals sought to facilitate research on the substances subject to class-wide scheduling245 or would have provided for expedited descheduling if a fentanyl-related substance were found not to pose a risk of abuse and dependence.246 In addition, based on concerns that individuals prosecuted for trafficking in fentanyl-related substances might face harsh penalties for offenses involving substances that pose little danger, some legislative proposals would have provided that mandatory minimum sentences under the CSA would not apply to those who committed certain offenses involving fentanyl-related substances.247 A key challenge in permanently scheduling fentanyl analogues is how to define the substances subject to regulation. The Fentanyl TSO identified a class of substances for control based on their chemical structures. On one hand, not all analogues of fentanyl have effects similar to fentanyl itself,248 so defining covered substances based on chemical structure may be overinclusive, potentially allowing for prosecution of individuals for prosecution of individuals
who possess who possess inactive substances that pose no threat to public health and safety.substances that pose no threat to public health and safety.~~243~~249 On the other hand, such On the other hand, such
a definition may also be a definition may also be ~~underinclusive~~underinclusive because it excludes opioids that are not because it excludes opioids that are not ~~chemical y~~chemically related related
to fentanyl or that are made using different modifications to fentanyl’s chemical structure.to fentanyl or that are made using different modifications to fentanyl’s chemical structure.~~244~~
~~Alternatively, defining~~250 Congress could also consider alternative approaches to class-wide scheduling. For example, a proposal during the 116th Congress, the Modernizing Drug Enforcement Act of 2019,251 would have identified covered opioids based on their effects rather than their chemical structure covered opioids based on their effects rather than their chemical structure, amending the CSA to add to Schedule I all “mu opioid receptor agonists” not otherwise scheduled, subject to certain exceptions.252 That approach might avoid the concerns about scope of control noted above. It is not clear it would significantly reduce the burden that prosecutors currently face when bringing controlled substance charges related to analogues, because prosecutors would need to show that a given substance had the required effects.253 (2021). See also Stopping Overdoses of Fentanyl Analogues Act, H.R. 2935, 116th Cong. (2019); S. 1622, 116th Cong. (2019). 245 See, e.g., HALT Fentanyl Act, H.R. 6184, 117th Cong. (2021); S. 3336, 117th Cong. (2021); SIFT Act of 2021, H.R. 2041, 117th Cong. (2021). 246 See, e.g., SAFE Act of 2022, H.R. 6946, 117th Cong. (2022). 247 See, e.g., id.; Federal Initiative To Guarantee Health by Targeting Fentanyl Act, H.R. 3269, 117th Cong. (2021). 248 To illustrate, DEA previously temporarily scheduled two fentanyl analogues before determining
~~would do little to reduce the burden that prosecutors currently face when bringing analogue~~
~~controlled substance charges.245~~
~~The 116th Congress did not permanently schedule fentanyl analogues, but it did take action to~~
~~facilitate DEA’s regulation of those substances. In February 2018, DEA issued an emergency~~
~~scheduling order that applied broadly to “fentanyl-related substances” that meet certain criteria~~
~~related to their chemical structure.246 The temporary scheduling order was set to expire in~~

~~235 See supra “Emergency Scheduling.”~~
~~236 See Fentanyl Analogues: Perspectives on Classwide Scheduling: Hearing Before the House Comm. on the Judiciary,~~
~~116th Cong. 2 (2019) (statement of the U.S. Dep’t of Justice).~~
~~237 See supra “Analogues and Listed Chemicals.”~~
~~238 DOJ T estimony, supra note 35 at 5.~~
~~239 21 U.S.C. §§ 802(32), 813; see also DOJ T estimony, supra note 35 at 5.~~
~~240 See CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea.~~
~~241 DOJ T estimony, supra note 35 at 5.~~
~~242 DEA previously temporarily scheduled two fentanyl analogues before determ ining~~ that the substances were that the substances were
“essentially inactive.” “essentially inactive.” See DEA, Correction of Code of Federal Regulations: DEA, Correction of Code of Federal Regulations: Removal of Removal of ~~T emporary~~Temporary Listing of Listing of
Benzylfentanyl and Benzylfentanyl and ~~T henylfentanyl~~Thenylfentanyl as Controlled Substances, as Controlled Substances, 75 Fed. Reg.75 Fed. Reg. 37,300, 37,300 (June 29, 2010). 37,300, 37,300 (June 29, 2010).
~~243~~ 249 See Letter from A New Letter from A New ~~PAT H~~ PATH, et al. to Sens. Graham and Feinstein (July 1, 2019), , et al. to Sens. Graham and Feinstein (July 1, 2019),
https://www.hrw.org/news/2019/07/03/coalitionhttps://www.hrw.org/news/2019/07/03/coalition -opposes-s1622-stopping-overdoses-fentanyl-analogues-act-sofa. -opposes-s1622-stopping-overdoses-fentanyl-analogues-act-sofa.
~~244~~250 The Countdown: Fentanyl Analogues & the Expiring Emergency Scheduling Order: Hearing Before the Sen. Comm.
on the Judiciary, 116th Cong. 2-3 (2019) (statement of Kemp L. Chester). , 116th Cong. 2-3 (2019) (statement of Kemp L. Chester).
~~245 See supra note 239.~~
~~246 DEA, Schedules of Controlled Substances: T emporary Placement of Fentanyl-Related Substances in Schedule I, 83~~
~~Fed. Reg. 5188 (Feb. 6, 2018). T he emergency scheduling order applies to “any substance not otherwise [subject to the~~
~~Congressional Research Service~~
24251 H.R. 2580, 116th Cong. (2019). 252 Mu opioid receptor agonists are a class are opioids including morphine, defined by the specific molecular reactions that produce their pharmacological effects. See Teresa Kasere, et al., μ Opioid Receptor: Novel Antagonists and Structural Modeling, SCIENTIFIC REPORTS (Feb. 18, 2016). 253 See supra note 231. Congressional Research Service 26

The Controlled Substances Act (CSA): A Legal Overview for the ~~117th Congress~~

~~February 2020.247 However, on February 6, 2020, Congress enacted the Temporary~~
~~Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act, which~~
~~extended the temporary scheduling of fentanyl-related substances until May 6, 2021.248 Absent~~
~~further legislative or administrative action, substances subject to the legislation wil remain in~~
~~Schedule I until that date and wil be subject to al restrictions and penalties applicable to~~
~~Schedule I substances. After the expiration date, the substances at issue wil no longer be~~
~~scheduled under the CSA but may stil be subject to control as controlled substance analogues.~~
~~Notably, fentanyl itself and certain other related chemicals are permanently controlled in~~
~~Schedules I and II.249 The Temporary Reauthorization and Study of the Emergency Scheduling of~~
~~Fentanyl Analogues Act does not affect those classifications.~~
~~Several proposals in the 116th Congress sought to permanently schedule fentanyl analogues. For~~
~~instance, the Stopping Overdoses of Fentanyl Analogues Act250 would have permanently added to~~
~~Schedule I certain specific synthetic opioids, as wel as the whole category of “fentanyl-related~~
~~substances,” as defined in the February 2018 emergency scheduling order. The Modernizing Drug~~
~~Enforcement Act of 2019251 would have amended the CSA to add to Schedule I al “mu opioid~~
~~receptor agonists” not otherwise scheduled, subject to certain exceptions.252 One of the sponsors~~
~~of the Modernizing Drug Enforcement Act stated that the bil ’s aim was “to automatical y classify~~
~~drugs or other substances that act as opioids, such as synthetic fentanyl, as a schedule I narcotic~~
~~based on their chemical structure and functions,” avoiding the need for such substances to be~~
~~individual y scheduled.253~~
~~Marijuana Policy Gap~~
~~Another area that raised a number of legal considerations for the 116th Congress is the marijuana~~
~~policy gap—the increasing divergence between federal and state law in the area of marijuana~~
~~regulation.254 As of December 2020, 15 states and the District of Columbia have passed laws~~
~~removing state prohibitions on medical and recreational marijuana use by adults age 21 or~~
~~older.255 An additional 33 states have passed laws permitting medical use of marijuana or the~~

~~CSA] that is structurally related to fentanyl by one or more [specified] modifications.” Id. at 5191-92.~~
~~247 Id. at 5188.~~
~~248 Pub. L. 116-114, 134 Stat. 103 (2020). For further discussion of the T emporary Reauthorization and Study of the~~
~~Emergency Scheduling of Fentanyl Analogues Act , see CRS Legal Sidebar LSB10404,~~ ~~Scheduling of Fentanyl~~
~~Analogues: The New Legal Landscape, by Joanna R. Lampe.~~
~~249 See 21 C.F.R. §§ 1308.11, 1308.12.~~
~~250 H.R. 2935, 116th Cong. (2019); S. 1622, 116th Cong. (2019). See also Zero T olerance for Deceptive Fentanyl~~
~~T rafficking Act , S. 3342, 116th Cong. (2020) (permanently adding “ fentanyl-related substances” to Schedule I and~~
~~imposing criminal penalties for knowingly misrepresenting or knowingly market ing as another substance a mixture or~~
~~substance containing fentanyl, a fentanyl analogue, or a fentanyl-related substance).~~
~~251 H.R. 2580, 116th Cong. (2019).~~
~~252 Mu opioid receptor agonists are a class are opioids including morphine, defined by the specific molecular reactions~~
~~that produce their pharmacological effects. See T eresa Kasere, et al.,~~ ~~μ Opioid Receptor: Novel Antagonists and~~
~~Structural Modeling, SCIENTIFIC REP ORTS (Feb. 18, 2016).~~
~~253 Press Release, Rep. Phil Roe, Roe, Suozzi Reintroduce the Modernizing Drug Enforcement Act (May 8, 2019),~~
~~https://roe.house.gov/news/documentsingle.aspx?DocumentID=400515.~~
~~254 See generally CRS Report R44782, The Marijuana Policy Gap and the Path Forward, coordinated by Lisa N.~~
~~Sacco.~~
~~255 See NAT’L CONFERENCE OF STATE LEGISLATURES, STATE MEDICAL MARIJUANA LAWS (Nov. 4, 2020),~~
~~http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx.~~
~~Congressional Research Service~~
25

~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~marijuana-derived compound cannabidiol (CBD).256 However, marijuana remains a Schedule I~~
~~controlled substance under federal law, and state legislation decriminalizing marijuana has no~~
~~effect on that status.257~~
~~In each budget cycle since FY2014 Congress has passed an appropriations rider prohibiting DOJ~~
~~from using taxpayer funds to prevent the states from “implementing their own laws that authorize~~
~~the use, distribution, possession, or cultivation of medical marijuana.”258 The current~~
~~appropriations rider is in effect through September 30, 2021.259 Several courts have interpreted~~
~~the appropriations rider to bar DOJ from expending any appropriated funds to prosecute activities~~
~~involving marijuana that are conducted in “strict compliance” with state law.260 For example, in~~
United States v. Evans, the Ninth Circuit upheld the prosecution of two individuals involved in
~~the production of medical marijuana who smoked marijuana as they processed plants for sale.261~~
~~Although state law permitted medical marijuana use by “qualifying patients,” the court concluded~~
~~that the defendants failed to show they were “qualifying patients,” and thus they could be~~
~~prosecuted because their personal marijuana use did not strictly comply with state medical~~
~~marijuana law.262~~
~~Notwithstanding the appropriations rider, activities that fal outside the scope of state medical~~
~~marijuana laws remain subject to prosecution. DOJ has typical y not prosecuted individuals who~~
~~possess marijuana for personal use on private property but instead has “left such lower-level or~~
~~localized marijuana activity to state and local authorities through enforcement of their own drug~~
~~laws.”263 However, DOJ issued guidance in 2018 reaffirming the authority of federal prosecutors~~
~~to exercise prosecutorial discretion to target federal marijuana offenses “in accordance with al~~
~~applicable laws, regulations, and appropriations.”264 Under that policy, DOJ has pursued~~

256 Id.
~~257 See, e.g., Gonzales v. Raich, 545 U.S. 1, 29 (2004). See also CRS Legal Sidebar LSB10482,~~ ~~State Marijuana~~
~~“Legalization” and Federal Drug Law: A Brief Overview for Congress, by Joanna R. Lampe. Notably, however, not all~~
~~CBD is subject to the CSA. T he 2018 Farm Bill exempted “ hemp”—cannabis and cannabis derivatives containing very~~
~~low levels of t etrahydrocannabinol (T HC)—from control under the CSA. See 21 U.S.C. § 802(16)(B)(i). Accordingly,~~
~~CBD that meets those requirements is no longer a federally controlled substance. CBD remains subject to federal~~
~~regulation under the FD&C Act, and FDA has taken the position that CBD is a drug that may not lawfully added to~~
~~foods or marketed as a dietary supplement. See Press Release, FDA, Statement from FDA Commissioner Scott~~
~~Gottlieb, M.D., on Signing of the Agriculture Improvement Act and the Agency’s Regulation of Products Containing~~
~~Cannabis and Cannabis-Derived Compounds (Dec. 20, 2018); see also Sean M. O’Connor & Erika Lietzan,~~ ~~The~~
~~Surprising Reach of FDA Regulation of Cannabis, Even After Descheduling~~ ~~, 68 AM. U. L. REV. 823 (2019); CRS In~~
~~Focus IF11250, FDA Regulation of Cannabidiol (CBD) Consum er Products, by Agata Bodie and Renée Johnson.~~
~~258 Pub. L. No. 116-260, Div. B, § 531 (2020). T he appropriations rider enumerates the specific states and territories to~~
~~which it applies. T he list excludes the four states that have not decriminalized medical marijuana use.~~
~~259 See id. § 5.~~
~~260 See United Sates v. McIntosh, 833 F.3d 1163, 1178 (9th Cir. 2016); Duval v. United States, 372 F. Supp. 3d 544,~~
~~555-56 (E.D. Mich. 2019); Sandusky v. Goetz, 2018 WL 6505803 at *4 -5 (D. Colo. Dec. 11, 2018); United States v.~~
~~Jackson, 2019 WL 3239844 at *6-8 (E.D. Pa. June 5, 2019).~~
~~261 929 F.3d 1073, 1076-79 (9th Cir. 2019). See also United States v. Kleinman, 880 F.3d 1020, 1027-30 (9th Cir.~~
~~2017) (prosecution was proper because sales of marijuana to out -of-state customers violated state law); United Sates v.~~
~~Bloomquist, 361 F. Supp. 3d 744, 749-51 (W.D. Mich. 2019) (same where defendant violated state law by possessing~~
~~excessive amounts of marijuana and selling marijuana to someone who was not allowed to use medical marijuana).~~
~~262 Evans, 929 F.3d at 1078-79 (9th Cir. 2019).~~
~~263 U.S. Government Accountability Office,~~ ~~State Marijuana Legalization: DOJ Should Document Its Approach to~~
~~Monitoring the Effects of Legalization, GAO-16-1, 9 (Dec. 2015).~~
~~264 Memorandum from Jefferson B. Sessions, Attorney Gen., U.S. Dep’t of Justice, on Marijuana Enforcement to all~~
~~United States Attorneys (Jan. 4, 2018), https://www.justice.gov/opa/press-release/file/1022196/download.~~
~~Congressional Research Service~~
26

~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~marijuana prosecutions in the context of large-scale trafficking operations or gang-related~~
~~activity.265~~
~~Furthermore, regardless of whether they are subject to criminal prosecution, participants in the~~
~~cannabis industry may face numerous~~ 118th Congress Supervised Consumption Sites Another prominent legal issue arising from the opioid epidemic concerns the legality of supervised consumption sites under the CSA. Supervised consumption sites (sometimes also called safe injection sites) are facilities that pursue a harm reduction strategy by permitting the use of controlled substances in the presence of staff who can administer overdose-reversal medications, distributing medical supplies such as sterile syringes, and offering referrals to social services including substance use treatment.254 In recent years, courts and policymakers have considered whether a provision of the CSA that prohibits “[m]aintaining drug-involved premises,” 21 U.S.C. § 856 (Section 856), bars the operation of supervised consumption sites. Congress first enacted Section 856 in 1986 in response to concerns about “crack houses”—premises where illicit drugs such as crack cocaine were manufactured, stored, distributed, and used.255 Congress amended the provision in 2003 to target facilities that hosted “raves,” where attendees distributed and used drugs such as MDMA.256 Section 856 imposes two criminal prohibitions. The first, contained in Section 856(a)(1), prohibits an entity from maintaining premises for its own drug-related activities.257 The second, Section 856(a)(2), prohibits making premises available for drug-related activity by third parties.258 Supervised consumption sites and their staff generally do not produce, distribute, or otherwise handle drugs, so legal questions related to such facilities center on Section 856(a)(2).259 In 2018, a nonprofit called Safehouse announced plans to open a supervised consumption site in Philadelphia. The United States sued Safehouse to block the proposed facility, arguing that the supervised consumption site would violate Section 856.260 On January 12, 2021, in United States v. Safehouse, the U.S. Court of Appeals for the Third Circuit agreed with the government.261 A majority of the three-judge panel held that Safehouse need not “have the purpose that its visitors use drugs” but rather “need only ‘knowingly and intentionally’ open its site to visitors who come ‘for the purpose of ... using’ drugs.”262 The court also concluded that, in “offer[ing] visitors a space to inject themselves with drugs,” Safehouse would violate Section 856 because the 254 See, e.g., Safehouse, The Safehouse Model, https://www.safehousephilly.org/about/the-safehouse-model (last visited Dec. 30, 2022); see also Substance Abuse and Mental Health Services Administration, Harm Reduction, https://www.samhsa.gov/find-help/harm-reduction (last visited Dec. 30, 2022); Jeffery C. Mays & Andy Newman, Nation’s First Supervised Drug-Injection Sites Open in New York, N.Y. TIMES (Nov. 30, 2021). 255 See Anti-Drug Abuse Act of 1986, P.L. 99-570, § 1841 (1986); see also, e.g., Nina Feldman, In Philadelphia, Judges Rule Against Opening 'Supervised' Site To Inject Opioids, NPR (Jan. 14, 2021). 256 See Protect Act, P.L. 108-21 § 608 (2003). 257 21 U.S.C. § 856(a)(1) (providing that it shall be unlawful to “knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the purpose of manufacturing, distributing, or using any controlled substance”). 258 21 U.S.C. § 856(a)(2) (providing that it shall be unlawful to “manage or control any place ... and knowingly and intentionally rent, lease, profit from, or make available for use, with or without compensation, the place for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance”). 259 See, e.g., Safehouse, Frequently Asked Questions, https://www.safehousephilly.org/frequently-asked-questions (last visited Dec. 30, 2022). 260 See Press Release, DOJ, Civil Lawsuit Filed to Seek Judicial Declaration that Drug Injection Site Is Illegal Under Federal Law (Feb. 6, 2019), https://www.justice.gov/usao-edpa/pr/civil-lawsuit-filed-seek-judicial-declaration-drug-injection-site-illegal-under-federal. 261 985 F.3d 225 (3d Cir. 2021). 262 Id. at 232. Congressional Research Service 27 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress organization “itself has a significant purpose that its visitors use heroin, fentanyl, and the like.”263 In response to Safehouse’s argument that this application was not what Congress intended when it enacted and amended Section 856, the majority held that the text of the statute was clear, so the court need not look beyond the text to other indicia of congressional intent.264 One member of the Third Circuit panel dissented. Senior Judge Roth contended that the text of Section 856 is ambiguous and that the majority erred in construing the ambiguous text in a way that imposed broad criminal liability.265 She would have also held that Safehouse lacked the requisite intent to violate Section 856 because it “is not motivated at least in part by a desire for unlawful drug activity to occur and ... in fact wants to reduce drug activity.”266 The Supreme Court declined to review the Third Circuit’s decision.267 As of January 2023, Safehouse has not commenced operation. However, other states and localities have begun considering whether to authorize such facilities. During the Safehouse litigation, there were already multiple reports of a supervised consumption site operating in secret in an undisclosed location, and local governments and other organizations outside Philadelphia had begun to consider similar facilities.268 In July 2021, Rhode Island enacted legislation authorizing supervised consumption sites under state law.269 The Illinois, Massachusetts, and New Mexico state legislatures have also considered legislation related to supervised consumption sites.270 The California legislature passed legislation in 2022 that would have allowed supervised consumption sites to operate on a trial basis in three cities,271 but the governor vetoed it, expressing concerns that the legislation might inadvertently “[w]orsen[ ] drug consumption challenges” in those cities.272 In November 2021, two supervised consumption sites began operating openly in New York City with the approval of the city government.273 The city reported that the sites were used 2,000 times in their first three weeks of operation and averted at least 59 potential overdose deaths.274 While DOJ actively opposed the operation of supervised consumption sites under the Trump Administration, to date the Biden Administration has not sought to invoke the CSA against such facilities. In February 2022, DOJ stated that it was “evaluating supervised consumption sites, 263 Id. at 238. 264 Id. at 238-39. 265 Id. at 244- 45 (Roth, S.J., dissenting). 266 Id. at 251 (Roth, S.J., dissenting). 267 Safehouse v. Dept. of Justice, 142 S. Ct. 345 (2021). 268 See, e.g., Ronnie Cohen, Drug Users Find Safety, Community in Underground Injection Facility, REUTERS (Jan. 12, 2018); Lenny Bernstein, A Secret, Supervised Place Where Users Can Inject Drugs Has Been Operating in the U.S. for Three Years, WASH. POST (Aug. 8, 2017); Gabrielle Masson, Massachusetts General Hosts Mock Safe Injection Site, BECKER’S HOSP. REV. (Oct. 16, 2019). 269 R.I. Stat. § 23-12.10-1 et seq; see also Aaron Warnick, Rhode Island Approves Nation’s First Sites for Safe Drug Injection Use, THE NATION’S HEALTH (Oct. 2021). 270 H.B. 100, 102nd Gen. Assembly (Ill. 2022); S. 1258, 192nd Gen. Ct. (Mass. 2021); H.B. 123, 55th Leg. (N.M. 2021). 271 S.B. 57, 2021-22 Reg. Sess. (Ca. 2021). 272 See Cheri Mossburg, Newsom Vetoes Bill Proposing Safe Drug Injection Sites in California, CNN (Aug. 22, 2022). 273 Press Release, NYC Dept. of Health & Mental Hygiene, Overdose Prevention Centers Averted 59 Overdoses in First Three Weeks of Operation (Dec. 21, 2021), https://www.nyc.gov/site/doh/about/press/pr2021/overdose-prevention-centers-prevent-59-deaths.page. 274 Id. Congressional Research Service 28 link to page 36 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress including discussions with state and local regulators about appropriate guardrails for such sites, as part of an overall approach to harm reduction and public safety.”275 In the meantime, uncertainty remains as to the legality of supervised consumption sites under the CSA. Congress could wait to see if other courts address the issue, or it could seek to resolve that uncertainty by enacting legislation. If Congress decided to allow supervised consumption sites to operate, it could consider the breadth of such authorization. One option would be to exempt supervised consumption sites from CSA control entirely. Alternatively, Congress might choose to exempt from federal prosecution facilities operating in compliance with state and local law, as it has done with state-sanctioned medical marijuana through a series of appropriations riders.276 Another option would be for Congress to impose specific registration requirements for supervised consumption sites under the CSA, as it has done for entities that administer medication-assisted treatment for opioid use disorder.277 If Congress decided not to allow supervised consumption sites, it could amend Section 856 to prohibit those facilities explicitly, as it did with respect to other activities in 2003,278 or enact separate legislation to ban supervised consumption sites. Congress could also withhold federal spending from supervised consumption sites.279 For example, a proposal during the 117th Congress would have prohibited federal funds from being “used by any Federal agency to operate or control ... an injection center” that violates Section 856.280 Others would have limited the availability of federal funds to states, localities, Indian tribes, and other entities that operate supervised consumption sites in violation of Section 856.281 Other Proposals Related to Opioid Regulation In addition to the proposals discussed above, numerous other legislative proposals in the 117th Congress sought to address the opioid crisis by amending the CSA.282 For instance, the LABEL Opioids Act would have required certain opioid medications subject to the CSA to bear a “clear, 275 Justice Department Signals It May Allow Supervised Injection Sites, CBS NEWS N.Y. (Feb. 8, 2022). 276 See infra “Appropriations Limitations.” 277 See 21 U.S.C. § 823(h); see also CRS In Focus IF10219, Opioid Treatment Programs and Related Federal Regulations, by Johnathan H. Duff. 278 See Protect Act, P.L. 108-21 § 608 (2003). 279 For background on Congress’s spending power, see Cong. Rsch. Serv., Overview of Spending Clause, CONSTITUTION ANNOTATED, https://constitution.congress.gov/browse/essay/artI-S8-C1-2-1/ALDE_00013356/ (last visited Dec. 30, 2022). 280 Crack is Whack Act, H.R. 6741, § 2, 117th Cong. (2022). 281 See Stop Injection Sites for Illegal Drugs Act of 2022, H.R. 7029, 117th Cong. (2022); Defund de Blasio’s Injection Sites Act of 2021, H.R. 6159, 117th Cong. (2021). 282 Numerous additional proposals to address the opioid epidemic fall outside the scope of this report. For instance, some proposals would amend the FD&C Act to increase liability for pharmaceutical companies or executives that violate the FD&C Act. See, e.g., FDA Accountability for Public Safety Act, S. 1439, 117th Cong. (2021); Protecting Americans from Dangerous Opioids Act, S. 1434, 117th Cong. (2021); Opioid Crisis Accountability Act, S. 1584, 116th Cong. (2019). Others would provide additional funding for local law enforcement efforts, opioid dependence treatment, or other related initiatives. See, e.g., Budgeting for Opioid Addiction Treatment Act, S. 1723, 117th Cong. (2022); Opioid Treatment Surge Act, S. 1662, 116th Cong. (2019). Some proposals would direct the Secretary of Homeland Security to designate “illicit fentanyl” as a weapon of mass destruction. See SOS Act of 2022, H.R. 9162, 117th Cong. (2022); Fentanyl is a WMD Act, H.R. 8030, 117th Cong. (2022); see also CRS Insight IN11902, Illicit Fentanyl and Weapons of Mass Destruction: International Controls and Policy Options, by Paul K. Kerr and Liana W. Rosen. Congressional Research Service 29 link to page 22 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress concise warning that the opioid dispensed can cause dependence, addiction, and overdose.”283 The Medication Access and Training Expansion Act of 2021 would have “require[d] physicians and other prescribers of controlled substances to complete training on treating and managing patients with opioid and other substance use disorders.”284 The Mainstreaming Addiction Treatment Act of 2021 would have relaxed CSA registration requirements for practitioners who dispense narcotic drugs in Schedules III, IV, or V (such as buprenorphine) for maintenance or detoxification treatment.285 The Harm Reduction Through Community Engagement Act of 2022 would have imposed additional registration requirements for opioid treatment programs.286 The Opioid QuOTA Act of 2021 would have required publication of the annual quotas that apply to each registered opioid manufacturer.287 Other proposals would have amended CSA provisions that impose criminal penalties for unauthorized activities involving opioids.288 Some proposals sought to increase criminal penalties for certain fentanyl-related offenses, imposing life in prison or the death penalty.289 Others would have lowered the amounts of fentanyl or fentanyl analogues required to trigger existing mandatory minimum sentences.290 Some proposals targeted misrepresenting the content of a substance containing fentanyl or manufacturing counterfeit substances that contain fentanyl and bear identifying marks of another product.291 Another proposal would have authorized special agents of Homeland Security Investigations to perform certain enforcement functions under the CSA.292 Federal and State Marijuana Regulation Another topic that raised a number of legal considerations for the 117th Congress is the increasing divergence between federal and state marijuana regulation.293 As of January 2023, 21 states, two territories, and the District of Columbia have passed laws removing prohibitions on medical and recreational marijuana use by adults age 21 or older.294 Thirty-seven states have passed laws permitting medical use of marijuana. Another 10 states authorize medical use of cannabis derivatives, such as cannabidiol (CBD), that contain low levels of tetrahydrocannabinol 283 H.R. 1026, 117th Cong. (2021); S. 2353, 117th Cong. (2021). 284 S. 2235, 117th Cong. (2021). 285 H.R. 1384, 117th Cong. (2021); S. 445, 117th Cong. (2021). 286 H.R. 8917, 117th Cong. (2021). 287 H.R. 6150, 117th Cong. (2021); S. 3327, 117th Cong. (2021). 288 For general discussion of the CSA’s trafficking provisions, see supra “Trafficking Provisions.” 289 See, e.g., Fentanyl Trafficker Elimination Act, H.R. 6439, 117th Cong. (2022); Death Penalty for Dealing Fentanyl Act of 2022, H.R. 8228, 117th Cong. (2022). 290 See, e.g., Fentanyl Penalties Parity Act, H.R. 5694, 117th Cong. (2021); Ending the Fentanyl Crisis Act of 2021, S. 1293, 117th Cong. (2021). 291 See, e.g., Zero Tolerance for Deceptive Fentanyl Trafficking Act, S. 4984, 117th Cong. (2022); Stop Pills That Kill Act, H.R. 8175, 117th Cong. (2022); S. 4151, 117th Cong. (2022). 292 Homeland Security Fentanyl Enforcement Act, H.R. 9093, 117th Cong. (2022). 293 See generally CRS Report R44782, The Evolution of Marijuana as a Controlled Substance and the Federal-State Policy Gap, coordinated by Lisa N. Sacco. 294 See Nat’l Conference of State Legislatures, State Medical Marijuana Laws (Nov. 9, 2022), http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx. Congressional Research Service 30 link to page 36 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress (THC).295 However, marijuana is a Schedule I controlled substance under federal law, and state marijuana legislation has no effect on that status.296 As discussed below, certain legal and practical considerations limit federal prosecutions of individuals and businesses involved in the state-legal marijuana industry.297 However, regardless of whether they are subject to criminal prosecution, marijuana users and participants in the state-legal marijuana industry may face collateral consequences arising from the federal prohibition collateral consequences arising from the federal prohibition
of marijuana. of marijuana. ~~Other~~Various federal laws impose legal consequences based on criminal activity, including federal laws impose legal consequences based on criminal activity, including
violationsviolations of the CSA. For example, even if authorized under state law, of the CSA. For example, even if authorized under state law, ~~cannabis~~marijuana businesses may businesses may
be unable to access banking services due to federal anti-money laundering laws,be unable to access banking services due to federal anti-money laundering laws,~~266~~298 and those and those
businesses may be ineligiblebusinesses may be ineligible for certain federal tax deductions.for certain federal tax deductions.~~267~~299 The involvement of income The involvement of income
from a from a ~~cannabis~~marijuana-related business may also prevent a bankruptcy court from approving a -related business may also prevent a bankruptcy court from approving a
bankruptcy plan.bankruptcy plan.~~268~~300 For individuals, For individuals, ~~participation in the cannabis industry~~some CSA violations involving marijuana may have adverse may have adverse
immigration consequences.immigration consequences.~~269 Drug~~301 Illicit drug use or convictions may limit individuals’ eligibility use or convictions may limit individuals’ eligibility ~~for~~
~~federal student financial aid and other benefits.270 Federal law also prohibits the possession of~~
~~firearms or ammunition by any person who is “an unlawful user of or addicted to any controlled~~
~~substance.”271 Furthermore, people who use marijuana, even for medical purposes, general y~~
~~enjoy little or no legal protection from adverse employment consequences.272~~

~~265 See, e.g., Press Release, DOJ, DEA Investigation in Chapel Hill Area Uncovers Large-Scale Drug Ring (Dec. 17,~~
~~2020), https://www.justice.gov/usao-mdnc/pr/dea-investigation-chapel-hill-area-uncovers-large-scale-drug-ring; Press~~
~~Release, DOJ, Pittsburgh-area Man Sentenced for Supplying SCO Gang with Drugs (Jan. 21, 2021),~~
~~https://www.justice.gov/usao-wdpa/pr/pittsburgh-area-man-sentenced-supplying-sco-gang-drugs; Press Release, DOJ,~~
~~Indictment Charges Bridgeport Gang Members with Drug T rafficking, Committing 4 Murders (Jan. 22, 2021),~~
~~https://www.justice.gov/usao-ct/pr/indictment -charges-bridgeport -gang-members-drug-trafficking-committing-4-~~
~~murders.~~
~~266 Anti-money laundering laws prohibit, inter alia, “conduct[ing] or attempt[ing] to conduct . . . a financial transaction~~
~~which in fact involves the proceeds of specified unlawful activity . . . with the intent to promote the carrying on of~~
~~specified unlawful activity” 18 U.S.C. §§ 1956(a). For a full list of predicate offenses, see the “ Specified Unlawful~~
~~Activities” section of CRS Report RL33315,~~ ~~Money Laundering: An Overview of 18 U.S.C. § 1956 and Related~~
~~Federal Crim inal Law, by Charles Doyle. For further discussion of banking law issues related to the marijuana policy~~
~~gap, see the “Banking and the Marijuana Industry” section of CRS Report R45726,~~ ~~Federal Preemption in the Dual~~
~~Banking System : An Overview and Issues for the 116th Congress, by Jay B. Sykes.~~
~~267 See 26 U.S.C. § 280E (“ No deduction or credit shall be allowed for any amount paid or incurred during the taxable~~
~~year in carrying on any trade or business if such trade or business (or the activities which comprise such trade or~~
~~business) consists of trafficking in controlled substances (within the meaning of schedule I and II of the Controlled~~
~~Substances Act) which is prohibited by Federal law or the law of any State in which such trade or business is~~
~~conducted.”).~~
~~268 A court may not confirm a bankruptcy plan “proposed . . . by any means forbidden by law.” 11 U.S.C. § 1129(a).~~
~~Courts have split on how that provision applies to cannabis-related businesses. Com pare Garvin v. Cook Investments~~
~~NW, SPNWY, LLC, 922 F.3d 1031, 1033 (9th Cir. 2019) (concluding that bankruptcy plan involving leased property~~
~~used to grow marijuana was not proposed “ by any means forbidden by law”), with In re Rent -Rite Super Kegs W. Ltd.,~~
~~484 B.R. 799, 809 (Bankr. D. Colo. 2012) (dismissing bankruptcy case where the debtor derived roughly 25% of its~~
~~revenues from leasing warehouse space to tenants who grew marijuana because “ a significant portion of the Debtor’s~~
~~income is derived from an illegal activity”) (footnote omitted).~~
~~269 See 8 U.S.C. § 1427(a) (providing that no person shall be naturalized unless that person, among other things, “ has~~
~~been and still is a person of good moral character”); 8 C.F.R. § 316.10(b)(2) (“An applicant shall be found to lack good~~
~~moral character if during the statutory period the applicant . . . [v]iolated any law of the United States, any State, or any~~
~~foreign country relating to a controlled substance, provided that the violation was not a single offense for simple~~
~~possession of 30 grams or less of marijuana”).~~
~~270 See CRS Legal Sidebar LSB10556, The MORE Act: House Plans Historic Vote on Federal Marijuana Legalization,~~
~~by Joanna R. Lampe; CRS Report R42394,~~ ~~Drug Testing and Crim e-Related Restrictions in TANF, SNAP, and Housing~~
~~Assistance, by Maggie McCarty et al.~~
~~271 18 U.S.C. § 922.~~
~~272 See Kathryn Evans, What Legal Protections Exist for Employees who Use Medical Marijuana? , NAT’L LAW REV.,~~
~~Oct. 21, 2020, https://www.natlawreview.com/article/what -legal-protections-exist-employees-who-use-medical-~~
~~Congressional Research Service~~
27

~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~Numerous proposals in the 116th Congress aimed to address issues related to the marijuana~~
~~policy gap. Some proposals targeted specific issues that arise from the divergence between~~
~~federal and state law. For instance, the Secure And Fair Enforcement Banking Act of 2019 (SAFE~~
~~Banking Act)273 sought to protect depository institutions that provide financial services to~~
~~cannabis-related businesses from regulatory sanctions. The Ensuring Safe Capital Access for Al~~
~~Smal Businesses Act of 2019274 would have made certain loan programs of the Smal Business~~
~~Administration (SBA) available to cannabis-related businesses.275~~
~~Other proposals sought to address the marijuana policy gap more broadly by attempting to~~
~~mitigate any conflict between federal and state law. For example, the State Cannabis Commerce~~
~~Act276 would have taken an approach similar to the current DOJ appropriations rider with respect~~
~~to al federal agencies. While that bil would not have altered the scope of the CSA’s restrictions~~
~~on marijuana, it would have prevented any federal agency from using appropriated funds “to~~
~~prevent any State from implementing any law of the State that . . . authorizes the use, distribution,~~
~~possession, or cultivation of marijuana” within the state. The Strengthening the Tenth~~
~~Amendment Through Entrusting States Act (STATES Act)277 would have amended the CSA to~~
~~provide that most provisions related to marijuana “shal not apply to any person acting in~~
~~compliance with State law relating to the manufacture, production, possession, distribution,~~
~~dispensation, administration, or delivery” of marijuana. The STATES Act would have removed~~
~~the risk of federal criminal prosecution under the CSA for individuals and entities whose~~
~~marijuana-related activities comply with state law, but the bil did not specifical y address the~~
~~potential consequences of such activity under other areas of federal law. The Responsibly~~
~~Addressing the Marijuana Policy Gap Act of 2019278 would have removed marijuana-related~~
~~activities that comply with state law from the scope of the CSA and also sought to address~~
~~specific collateral consequences of such activities, including access to banking services,~~
~~bankruptcy proceedings, and certain tax deductions.~~
~~Additional proposed legislation would have changed federal policy with respect to marijuana by~~
~~altering its status under the CSA, thus also addressing the policy gap between federal and state~~
~~law. Some proposals would have moved marijuana from Schedule I to a less restrictive~~
~~schedule.279 Others would have removed marijuana from the CSA’s schedules completely.280~~
~~Removing marijuana from the coverage of the CSA could, however, raise new legal issues. For~~
~~instance, by default, the repeal of federal criminal prohibitions rarely applies retroactively.281 As a~~

~~marijuana.~~
~~273 H.R. 1595, 116th Cong. (2019); S. 1200, 116th Cong. (2019). The SAFE Banking Act passed the House on~~
~~September 25, 2019. T he 116th Congress adjourned without taking final legislative action on either bill.~~
~~274 H.R. 3540, 116th Cong. (2109).~~
~~275 See also Ensuring Access to Counseling and T raining for All Small Businesses Act of 2019 , H.R. 3543, 116th Cong.~~
~~(2019) (ensuring access to SBA entrepreneurial development services).~~
~~276 H.R. 3546, 116th Cong. (2019); S. 2030, 116th Cong. (2019).~~
~~277 H.R. 2093, 116th Cong. (2019); S. 1028, 116th Cong. (2019).~~
~~278 H.R. 1119, 116th Cong. (2019); S. 421, 116th Cong. (2019).~~
~~279 See, e.g., Legitimate Use of Medicinal Marihuana Act , H.R. 171, 116th Cong. (2019); Compassionate Access Act,~~
~~H.R. 715, 115th Cong. (2017).~~
~~280 See, e.g., MORE Act of 2019, H.R. 3884 (116th Cong. 2019); S. 2227 (116th Cong. 2019); Marijuana Justice Act of~~
~~2019, H.R. 1456, 116th Cong. (2019); S. 597, 116th Cong. (2019).~~
~~281 See 1 U.S.C. § 109 (federal savings statute providing that “[t]he repeal of any statute shall not have the effect to~~
~~release or extinguish any penalty, forfeiture, or liability incurred under such statute, unless the repealing Act shall so~~
~~expressly provide, and such statute shall be treated as still remaining in force for the purpose of sustaining any proper~~
~~Congressional Research Service~~
28

~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~result, if Congress were to remove marijuana from the CSA, it might want to consider how to~~
~~address past criminal convictions related to marijuana and whether to take any action to mitigate~~
~~the effects of past convictions.282~~
~~One high-profile proposal in the 116th Congress, the Marijuana Opportunity Reinvestment and~~
~~Expungement Act of 2019 (MORE Act)283 is noteworthy as the first time either chamber of~~
~~Congress voted on a proposal to decriminalize marijuana.284 That bil aimed to “decriminalize and~~
~~deschedule cannabis, to provide for reinvestment in certain persons adversely impacted by the~~
~~War on Drugs, [and] to provide for expungement of certain cannabis offenses.” Key provisions of~~
~~the MORE Act would have (1) removed marijuana from Schedule I, (2) required expungement of~~
~~past federal cannabis offenses, (3) prohibited the denial of any “Federal public benefit” or “any~~
~~benefit or protection under the immigration laws” based on cannabis use or a past cannabis~~
~~conviction, (4) imposed a 5 percent tax on cannabis to fund community reinvestment grants~~
~~supporting substance abuse treatment programs and other services, and (5) provided funding for~~
~~loans to assist smal cannabis businesses that are owned and controlled by social y and~~
~~economical y disadvantaged individuals.285~~
~~If Congress were to remove marijuana from the ambit of the CSA, that would not affect other~~
~~existing statutes and regulations that apply to the drug and thus would not bring aspects of the~~
~~existing cannabis industry into compliance with federal law.286 For instance, marijuana and~~
~~substances derived from the plant are currently regulated under the FD&C Act. FDA has~~
~~explained that it “treat[s] products containing cannabis or cannabis-derived compounds as [it~~
~~does] any other FDA-regulated products.” 287 FDA has approved drugs made from CBD and~~
~~tetrahydrocannabinol (THC); therefore the agency deems those compounds to be drugs and takes~~
~~the position that it is “unlawful under the FD&C Act to introduce food containing added CBD or~~
~~THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements,~~
~~regardless of whether the substances are hemp-derived.”288 FDA is currently engaged in~~
~~“consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-~~

~~action or prosecution for the enforcement of such penalty, forfeiture, or liability”); Hurwitz v. United States, 53 F.2d~~
~~552, 552 (D.C. Cir. 1931) (applying then -applicable federal savings statute to prevent retroactive application of the~~
~~repeal of a criminal law to a prosecution undertaken before the repeal); see also S. David Mitchell,~~ ~~In With the Old, Out~~
~~With the New: Expanding the Scope of Retroactive Am elioration~~ ~~, 37 AM. J. CRIM. L. 1, 28-38 (2009).~~
~~282 See, e.g.,~~ ~~Marijuana Laws in America: Racial Justice and the Need for Reform : Hearing Before the House Comm.~~
~~on the Judiciary, 116th Cong. 12-13 (2019) (statement of Marilyn J. Mosby).~~
~~283 H.R. 3884 (116th Cong. 2019); S. 2227 (116th Cong. 2019). T he MORE Act passed the House on December 4,~~
~~2020.~~
~~284 See Nicholas Wu, House Will Vote on Federal Marijuana Legalization for the First T ime, Bill’s Future in Senate~~
~~Uncertain, USA T ODAY, Sept. 4, 2020.~~
~~285 For additional information on the MORE Act, see CRS Legal Sidebar LSB10556,~~ ~~The MORE Act: House Plans~~
~~Historic Vote on Federal Marijuana Legalization~~ ~~, by Joanna R. Lampe.~~
~~286 See Press Release, FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on Signing of the Agriculture~~
~~Improvement Act and the Agency’s Regulation of Products Containing Cannabis and Cannabis-Derived Compounds~~
~~(Dec. 20, 2018), https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-~~
~~md-signing-agriculture-improvement -act-and-agencys; see also CRS In Focus IF11250,~~ ~~FDA Regulation of~~
~~Cannabidiol (CBD) Consum er Products, by Agata Bodie and Renée Johnson.~~
~~287 Press Release, FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on Signing of the Agriculture~~
~~Improvement Act and the Agency’s Regulation of Products Containing Cannabis and Cannabis-Derived Compounds~~
~~(Dec. 20, 2018), https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-~~
~~md-signing-agriculture-improvement -act-and-agencys.~~
288 Id.
~~Congressional Research Service~~
29

~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~derived products under our existing authorities.”289 Congress could also enact legislation to alter~~
~~FDA regulation of cannabis-based products. For example, the Legitimate Use of Medicinal~~
~~Marihuana Act would have provided that neither the CSA nor the FD&C Act “shal prohibit or~~
~~otherwise restrict” certain activities related to medical marijuana that are legal under state law.290~~
~~In addition, Congress might enact new legislation affecting marijuana in conjunction with any~~
~~legislation removing it from the scope of the CSA. For instance, legislation introduced during the~~
~~116th Congress would have imposed new federal regulations on marijuana akin to those~~
~~applicable to alcohol and tobacco.291~~
~~Reducing or removing federal restrictions on marijuana might also create tension with certain~~
~~treaty obligations of the United States. The United States is a party to the Single Convention on~~
~~Narcotic Drugs of 1961 (1961 Convention), which requires signatories, among other things, to~~
~~criminalize “cultivation, production, manufacture, extraction, preparation, possession, offering,~~
~~offering for sale, distribution, purchase, sale, . . . importation and exportation of drugs” contrary~~
~~to the provisions of the Convention.292 The United States is also party to the Convention on~~
~~Psychotropic Substances of 1971, which requires parties to impose various restrictions on~~
~~controlled substances, including measures “for the repression of acts contrary to laws or~~
~~regulations” adopted pursuant to treaty obligations.293 Both conventions require parties to impose~~
~~certain controls on cannabis; however, in December 2020, the United Nations Commission on~~
~~Narcotic Drugs voted to remove some of the restrictions on cannabis under the 1961~~
~~Convention.294 While some commentators view that vote as part of a significant shift in~~
~~international cannabis policy,295 cannabis and its derivatives remain subject to restrictions under~~
~~the international drug control treaties that may be inconsistent with legalization of marijuana,~~
~~particularly for recreational purposes.296 The treaties are not self-executing,297 meaning that they~~

~~289 Press Release, FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on New Steps to Advance Agency’s~~
~~Continued Evaluation of Potential Regulatory Pathways for Cannabis-Containing and Cannabis-Derived Products (Apr.~~
~~2, 2019), https://www.fda.gov/news-events/press-announcements/statement~~ for 295 Id. 296 See, e.g., Gonzales v. Raich, 545 U.S. 1, 29 (2004). See also CRS Legal Sidebar LSB10482, State Marijuana “Legalization” and Federal Drug Law: A Brief Overview for Congress, by Joanna R. Lampe. Notably, however, not all CBD is subject to the CSA. The 2018 Farm Bill exempted “hemp”—cannabis and cannabis derivatives containing very low levels of THC—from control under the CSA. See 21 U.S.C. § 802(16)(B)(i). Accordingly, CBD that meets those requirements is no longer a federally controlled substance. CBD remains subject to federal regulation under the FD&C Act, and FDA has taken the position that CBD is a drug that may not lawfully added to foods or marketed as a dietary supplement. See Press Release, FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on Signing of the Agriculture Improvement Act and the Agency’s Regulation of Products Containing Cannabis and Cannabis-Derived Compounds (Dec. 20, 2018); see also Sean M. O’Connor & Erika Lietzan, The Surprising Reach of FDA Regulation of Cannabis, Even After Descheduling, 68 AM. U. L. REV. 823 (2019); CRS In Focus IF11250, FDA Regulation of Cannabidiol (CBD) Consumer Products, by Agata Bodie and Renée Johnson. 297 See infra “Appropriations Limitations.” 298 Anti-money laundering laws prohibit, inter alia, “conduct[ing] or attempt[ing] to conduct ... a financial transaction which in fact involves the proceeds of specified unlawful activity ... with the intent to promote the carrying on of specified unlawful activity” 18 U.S.C. §§ 1956(a). For a full list of predicate offenses, see the “Specified Unlawful Activities” section of CRS Report RL33315, Money Laundering: An Overview of 18 U.S.C. § 1956 and Related Federal Criminal Law, by Charles Doyle. For further discussion of banking law issues related to the marijuana policy gap, see the “Federal Financial Laws and Financial Services for Marijuana Businesses” section of CRS Report R44782, The Evolution of Marijuana as a Controlled Substance and the Federal-State Policy Gap, coordinated by Lisa N. Sacco. 299 See 26 U.S.C. § 280E (“No deduction or credit shall be allowed for any amount paid or incurred during the taxable year in carrying on any trade or business if such trade or business (or the activities which comprise such trade or business) consists of trafficking in controlled substances (within the meaning of schedule I and II of the Controlled Substances Act) which is prohibited by Federal law or the law of any State in which such trade or business is conducted.”). See generally CRS Report R46709, The Application of Internal Revenue Code Section 280E to Marijuana Businesses: Selected Legal Issues, by Milan N. Ball. 300 A court may not confirm a bankruptcy plan “proposed ... by any means forbidden by law.” 11 U.S.C. § 1129(a). Courts have split on how that provision applies to cannabis-related businesses. Compare Garvin v. Cook Investments NW, SPNWY, LLC, 922 F.3d 1031, 1033 (9th Cir. 2019) (concluding that a bankruptcy plan involving leased property used to grow marijuana was not proposed “by any means forbidden by law”), with In re Rent-Rite Super Kegs W. Ltd., 484 B.R. 799, 809 (Bankr. D. Colo. 2012) (dismissing a bankruptcy case where the debtor derived roughly 25% of its revenues from leasing warehouse space to tenants who grew marijuana because “a significant portion of the Debtor’s income is derived from an illegal activity”) (footnote omitted). 301 See 8 U.S.C. § 1427(a) (providing that no person shall be naturalized unless that person, among other things, “has been and still is a person of good moral character”); 8 C.F.R. § 316.10(b)(2) (“An applicant shall be found to lack good moral character if during the statutory period the applicant ... [v]iolated any law of the United States, any State, or any foreign country relating to a controlled substance, provided that the violation was not a single offense for simple possession of 30 grams or less of marijuana”). Congressional Research Service 31 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress federal student financial aid and other benefits.302 Federal law also prohibits the possession of firearms or ammunition by any person who is “an unlawful user of or addicted to any controlled substance.”303 Furthermore, people who use marijuana, even for medical purposes, generally enjoy little or no legal protection from adverse employment consequences.304 Appropriations Limitations Congress has addressed the divergence between federal and state marijuana law in part by limiting enforcement of the CSA against certain state-legal activities related to medical marijuana. In each budget cycle since FY2015, Congress has passed an appropriations rider prohibiting DOJ from using taxpayer funds to prevent the states from “implementing their own laws that authorize the use, distribution, possession, or cultivation of medical marijuana.”305 The current appropriations rider is in effect through September 30, 2023.306 Several federal courts have interpreted the appropriations rider to bar DOJ from expending any appropriated funds to prosecute activities involving marijuana that are conducted in “strict compliance” with state law.307 For example, in the 2019 case United States v. Evans, the Ninth Circuit upheld the prosecution of two individuals involved in the production of medical marijuana who smoked marijuana as they processed plants for sale.308 Although state law permitted medical marijuana use by “qualifying patients,” the court concluded that the defendants failed to show they were “qualifying patients,” and thus they could be prosecuted because their personal marijuana use did not strictly comply with state medical marijuana law.309 More recently, in the 2022 case United States v. Bilodeau, the First Circuit held that the rider also bars prosecution in some cases where defendants did not strictly comply with state medical marijuana law.310 The First Circuit noted that the text of the rider does not explicitly require strict compliance with state law and that, given the complexity of state marijuana regulations, “the potential for technical noncompliance [with state law] is real enough that no person through any reasonable effort could always assure strict compliance.”311 Thus, the First Circuit concluded that requiring strict compliance with state law would likely chill state-legal medical marijuana 302 See CRS Legal Sidebar LSB10556, The MORE Act: House Plans Historic Vote on Federal Marijuana Legalization, by Joanna R. Lampe; CRS Report R42394, Drug Testing and Crime-Related Restrictions in TANF, SNAP, and Housing Assistance, by Maggie McCarty et al. 303 18 U.S.C. § 922. 304 See Kathryn Evans, What Legal Protections Exist for Employees who Use Medical Marijuana?, NAT’L LAW REV. (Oct. 21, 2020), https://www.natlawreview.com/article/what-legal-protections-exist-employees-who-use-medical-marijuana. 305 P.L. 117-328, div. B, § 531. The appropriations rider enumerates the specific states and territories to which it applies. The list excludes the three states that have not decriminalized medical marijuana use. 306 See id. § 5. 307 See United States v. McIntosh, 833 F.3d 1163, 1178 (9th Cir. 2016); Duval v. United States, 372 F. Supp. 3d 544, 555-56 (E.D. Mich. 2019); Sandusky v. Goetz, 2018 WL 6505803 at *4-5 (D. Colo. Dec. 11, 2018); United States v. Jackson, 2019 WL 3239844 at *6-8 (E.D. Pa. June 5, 2019). 308 929 F.3d 1073, 1076-79 (9th Cir. 2019). See also United States v. Kleinman, 880 F.3d 1020, 1027-30 (9th Cir. 2017) (prosecution was proper because sales of marijuana to out-of-state customers violated state law); United Sates v. Bloomquist, 361 F. Supp. 3d 744, 749-51 (W.D. Mich. 2019) (same where defendant violated state law by possessing excessive amounts of marijuana and selling marijuana to someone who was not allowed to use medical marijuana). 309 Evans, 929 F.3d at 1078-79 (9th Cir. 2019). 310 24 F.4th 705 (2022). 311 Id. at 713. Congressional Research Service 32 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress activities and prevent the states from giving effect to their medical marijuana laws.312 However, the court also rejected the defendants’ argument that the rider “must be read to preclude the DOJ, under most circumstances, from prosecuting persons who possess state licenses to partake in medical marijuana activity.”313 Ultimately, the First Circuit held that the rider bars CSA prosecution in at least some cases where the defendant has committed minor technical violations of state medical marijuana laws, but it declined to “fully define [the] precise boundaries” of its alternative standard.314 It remains to be seen whether and how the difference in reasoning between the Ninth Circuit and the First Circuit will make a practical difference in federal marijuana prosecutions.315 Congress has the power to enact legislation adopting its preferred interpretation of the rider or otherwise clarifying its scope. Congress could also expand the scope of the rider to bar prosecution of other state-legal activities involving marijuana316 or limit or repeal the rider. Executive Branch Policy and Simple Possession Pardon Notwithstanding the appropriations rider, activities that fall outside the scope of state medical marijuana laws remain potentially subject to federal prosecution. This includes all state-legal activities involving recreational marijuana. As a practical matter, DOJ has typically not prosecuted individuals who possess marijuana for personal use on private property but instead has “left such lower-level or localized marijuana activity to state and local authorities through enforcement of their own drug laws.”317 DOJ issued guidance in 2018 reaffirming the authority of federal prosecutors to exercise prosecutorial discretion to target federal marijuana offenses “in accordance with all applicable laws, regulations, and appropriations.”318 In recent years, DOJ has pursued marijuana prosecutions in the context of large-scale trafficking operations or gang-related activity.319 The Biden Administration DOJ has not issued formal guidance on marijuana policy, 312 Id. at 713-14. 313 Id. at 714. 314 Id. at 715. On the record before it, the court concluded that “the defendants’ cultivation, possession, and distribution of marijuana aimed at supplying persons whom no defendant ever thought were qualifying patients under Maine law” and that a CSA conviction in those circumstances would not “prevent Maine’s medical marijuana laws from having their intended practical effect.” Id. 315 In theory, the First Circuit’s analysis could make it easier for defendants to invoke the appropriations rider to bar federal prosecutions, because they could do so even if they had not been in strict compliance with state law. In practice, however, resource limitations and enforcement priorities have historically meant that federal marijuana prosecutions target individuals and organizations that have clearly not complied with state medical marijuana law. Thus, one of the First Circuit judges who considered Bilodeau agreed with the panel’s interpretation of the rider but wrote a concurrence noting that, in practice, the First Circuit’s standard might not be “materially different from the one that the Ninth Circuit applied.” Id. at 718 (Barron, J., concurring). 316 See, e.g., State Cannabis Commerce Act, H.R. 3546, 116th Cong. (2019); S. 2030, 116th Cong. (2019); cf. STATES Act, H.R. 2093, 116th Cong. (2019); S. 1028, 116th Cong. (2019) (proposal to amend the CSA to provide that most provisions related to marijuana “shall not apply to any person acting in compliance with State law relating to the manufacture, production, possession, distribution, dispensation, administration, or delivery” of marijuana). 317 U.S. Government Accountability Office, State Marijuana Legalization: DOJ Should Document Its Approach to Monitoring the Effects of Legalization, GAO-16-1, 9 (Dec. 2015). 318 Memorandum from Jefferson B. Sessions, Attorney Gen., U.S. Dep’t of Justice, on Marijuana Enforcement to all United States Attorneys (Jan. 4, 2018), https://www.justice.gov/opa/press-release/file/1022196/download. 319 See, e.g., Press Release, DOJ, DEA Investigation in Chapel Hill Area Uncovers Large-Scale Drug Ring (Dec. 17, 2020), https://www.justice.gov/usao-mdnc/pr/dea-investigation-chapel-hill-area-uncovers-large-scale-drug-ring; Press Release, DOJ, Pittsburgh-area Man Sentenced for Supplying SCO Gang with Drugs (Jan. 21, 2021), https://www.justice.gov/usao-wdpa/pr/pittsburgh-area-man-sentenced-supplying-sco-gang-drugs; Press Release, DOJ, Indictment Charges Bridgeport Gang Members with Drug Trafficking, Committing 4 Murders (Jan. 22, 2021), Congressional Research Service 33 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress but Attorney General Merrick Garland has indicated that the agency will not prioritize prosecuting individuals for personal use of marijuana.320 On October 6, 2022, President Biden issued a proclamation granting “a full, complete, and unconditional pardon” to “all current United States citizens and lawful permanent residents” who had committed or been convicted of simple possession of marijuana under the CSA or a related provision of the D.C. Code.321 President Biden’s invocation of the clemency power means that people who committed simple possession of marijuana before the date of the proclamation may not be prosecuted or punished for the offense under the relevant provisions of the CSA or the D.C. Code.322 Several factors limit the scope of the pardon. First, it applies only to violations of federal and D.C. law and does not affect other state law marijuana offenses, because the President has no direct power to change state law or compel the states to adopt federal policies.323 Second, the pardon applies only to simple possession of marijuana, which the federal government rarely prosecutes.324 It does not apply to other marijuana-related CSA offenses such as manufacture, distribution, or possession with intent to distribute or to other federal crimes.325 https://www.justice.gov/usao-ct/pr/indictment-charges-bridgeport-gang-members-drug-trafficking-committing-4-murders. 320 See, e.g., Hearing Before the Sen. Appropriations Subcommittee on Commerce, Justice, Science, and Related Agencies, 117th Cong. (Apr. 26, 2022) (testimony of Atty. Gen. Merrick B. Garland) (“I think I laid this out actually also in my confirmation hearing and my view hasn’t really changed since then, and that is that the Justice Department has almost never prosecuted use of marijuana and that’s not an efficient use of the resources given the opioid and methamphetamine epidemic that we have.”). 321 Joseph R. Biden, A Proclamation on Granting Pardon for the Offense of Simple Possession of Marijuana (Oct. 6, 2022). 322 Although the District of Columbia has its own criminal code, its criminal justice system has some overlap with the federal system and is subject to the President’s clemency power. For additional information on the President’s clemency power, see CRS Report R46179, Presidential Pardons: Overview and Selected Legal Issues, by Michael A. Foster. 323 See id., “Constraints on the Pardon Power.” In announcing the pardon, President Biden also encouraged state governors to grant clemency for state offenses. While some governors have taken such steps or expressed willingness to do so, in some states, governors cannot independently grant clemency. See, e.g., David Montgomery, Governors Split on Biden’s Call to Pardon Low-Level Pot Offenders, PEW (Oct. 28, 2022), https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2022/10/28/governors-split-on-bidens-call-to-pardon-low-level-pot-offenders. The pardon also does not apply to offenses under the Uniform Code of Military Justice. See, e.g., Michael Lee, Biden’s Pardon of Marijuana Offenses Won’t Apply to Military, FOX NEWS (Oct. 9, 2022), https://www.foxnews.com/politics/bidens-pardons-marijuana-offenses-wont-apply-military. 324 The U.S. Sentencing Commission (USSC) reports that about 7,700 people subject to the pardon were convicted of only simple possession since FY1992, none of whom were in federal custody at the time of the grant of clemency. USSC, Number of Federal Offenders Convicted Only of 21 U.S.C. § 844 Involving Marijuana, Fiscal Years 1992 – 2021, https://www.ussc.gov/sites/default/files/pdf/news/press-releases-and-news-advisories/news-advisories/20221012_Updated-News-Advisory-Data-Analysis.pdf. In FY2021, 117 people subject to the pardon were convicted of only simple possession. See id. Additional individuals convicted of simple possession were not subject to the pardon. See USSC, WEIGHING THE CHARGES: SIMPLE POSSESSION OF DRUGS IN THE FEDERAL CRIMINAL JUSTICE SYSTEM 6 (Sept. 2016). 325 The USSC reports that 425 people were convicted of possessing marijuana and possessing other illicit drugs. USSC, Number of Federal Offenders Convicted Only of 21 U.S.C. § 844 Involving Marijuana and Other Drugs, Fiscal Years 1992 – 2021, https://www.ussc.gov/sites/default/files/pdf/news/press-releases-and-news-advisories/news-advisories/20221012_Updated-News-Advisory-Data-Analysis.pdf#page=2. In addition, 585 people were convicted of simple possession of marijuana and one or more other crimes. USSC, Number of Federal Offenders Convicted of 21 U.S.C. § 844 Involving Only Marijuana Who Also Have Other Convictions, Fiscal Years 1992 – 2021, https://www.ussc.gov/sites/default/files/pdf/news/press-releases-and-news-advisories/news-advisories/20221012_Updated-News-Advisory-Data-Analysis.pdf#page=3. Those people would remain liable for the Congressional Research Service 34 link to page 35 link to page 36 link to page 16 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress Third, the pardon by its terms “does not apply to individuals who were non-citizens not lawfully present in the United States at the time of their offense.”326 Fourth, the pardon applies only to offenses committed before the proclamation.327 Thus, while DOJ is currently not prioritizing prosecuting low-level marijuana offenses, the October 2022 pardon does not prevent prosecution of future offenses if the current Administration or a future Administration adopts a different policy. Fifth, the pardon may not remove all legal consequences of marijuana possession, because it does not expunge convictions.328 Moreover, some collateral consequences of marijuana-related activities do not depend on a person being charged with or convicted of a CSA violation.329 In addition, and most fundamentally, the pardon does not change the status of marijuana under federal law. The President lacks the power to make such a change unilaterally.330 In announcing the grant of clemency, President Biden directed the Attorney General to review the classification of marijuana under the CSA.331 Such review is one way the federal government could change the status of the substance consistently with relevant separation-of-powers principles and the CSA’s procedural requirements.332 Any agency action in response to that directive would likely occur through notice-and-comment rulemaking and would be subject to judicial review333 and applicable international treaty obligations.334 Proposed Marijuana Legislation Numerous proposals introduced in the 117th Congress would have changed how the federal government regulates marijuana. Congress has broad power to regulate marijuana or relax federal regulation of the substance as part of its authority over interstate commerce.335 other offenses. After the pardon was announced, the USSC issued policy priorities including “consideration of possible amendments to the [Sentencing] Guidelines Manual relating to criminal history to address … the impact of simple possession of marihuana offenses.” USSC, Final Priorities for Amendment Cycle, 87 Fed. Reg. 67,756, 67,756 (Nov. 9, 2022). 326According to a 2016 USSC report, the vast majority of federal marijuana possession arrests occur at the border between the United States and Mexico and involve non-citizens. See USSC, WEIGHING THE CHARGES: SIMPLE POSSESSION OF DRUGS IN THE FEDERAL CRIMINAL JUSTICE SYSTEM 5-6 (Sept. 2016). Among offenders sentenced for marijuana possession in FY2013, over 94% of those arrested at the border were not U.S. citizens. Id. at 6. To the extent those individuals were not lawfully present in the country, they would not benefit from the pardon. 327 The Supreme Court has explained that the President may issue a pardon “at any time after [an offense’s] commission, either before legal proceedings are taken, or during their pendency, or after conviction and judgment.” Ex parte Garland, 71 U.S. 333, 380 (1866). 328 See DOJ, Presidential Proclamation on Marijuana Possession (Nov. 2, 2022), https://www.justice.gov/pardon/presidential-proclamation-marijuana-possession. 329 See supra notes 298-304 and accompanying text. 330 See CRS Legal Sidebar LSB10655, Does the President Have the Power to Legalize Marijuana?, by Joanna R. Lampe. 331 Joseph R. Biden, A Proclamation on Granting Pardon for the Offense of Simple Possession of Marijuana (Oct. 6, 2022). 332 See, e.g., Youngstown Sheet & Tube Co. v. Sawyer, 343 U.S. 579, 585 (1952); 21 U.S.C. § 811. 333 See 21 U.S.C. § 877. 334 The relevant treaties are not self-executing and do not directly bind Congress or private parties, but the CSA requires DEA to schedule substances as needed to satisfy the United States’ treaty obligations. See 21 USC § 811(d)(1) (“If control is required by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations[.]”); see also supra “International Treaty Obligations.” 335 Gonzales v. Raich, 545 U.S. 1, 15 (2004). For background on Congress’s power to regulate interstate commerce, see Cong. Rsch. Serv., Overview of Commerce Clause, CONSTITUTION ANNOTATED, Congressional Research Service 35 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress Several recent proposals would have removed marijuana from control under the CSA. One high-profile descheduling proposal, the Marijuana Opportunity Reinvestment and Expungement Act (MORE Act), would have removed marijuana and THC from control under the CSA and required expungement of past convictions for many federal marijuana offenses.336 Among other things, it would have also removed some collateral consequences for marijuana-related activities,337 imposed a 5% tax on cannabis products,338 and used revenues from the tax to fund certain grant programs for disadvantaged individuals and “individuals adversely impacted by the War on Drugs.”339 The MORE Act passed the House in April 2022 but did not pass the Senate.340 Another descheduling proposal, the Cannabis Administration and Opportunity Act, would have removed from Schedule I marijuana and THC derived from the cannabis plant.341 It would have also provided for expungement of certain past marijuana convictions,342 but it would have retained federal criminal liability for cannabis-related activities not conducted pursuant to a federal permit or authorized under the law of the states where they occur.343 In addition, among other things, it would have provided guidance for regulation of cannabis products under the FD&C Act.344 It would also have imposed a 10%-25% tax on cannabis products345 and used revenues from the tax to fund programs including small business development, community reinvestment, and opioid abuse treatment.346 Other legislative proposals from the 117th Congress would likewise have removed marijuana from control under the CSA.347 Removing marijuana from the coverage of the CSA could raise several legal considerations. First, by default, the repeal of federal criminal prohibitions rarely applies retroactively.348 To address this, some descheduling proposals also include provisions designed to address past criminal convictions related to marijuana.349 Second, removing marijuana from the ambit of the CSA https://constitution.congress.gov/browse/essay/artI-S8-C3-1/ALDE_00013403/ (last visited Jan. 3, 2023). 336 H.R. 3617, §§ 3, 10, 117th Cong. (2021). 337 Id. §§ 7-9. 338 Id. § 5. 339 Id. §§ 5-6. 340 A previous version of the MORE Act passed the House in December 2020, the first time either chamber of Congress voted on a proposal to decriminalize marijuana. See H.R. 3884, 116th Cong. (2020), see also Nicholas Wu, House Will Vote on Federal Marijuana Legalization for the First Time, Bill’s Future in Senate Uncertain, USA TODAY, Sept. 4, 2020. 341 S. 4591, § 101, 117th Cong. (2022). 342 Id. § 311. 343 Id. § 112. 344 Id. § 501. 345 Id. § 401. 346 Id. §§ 301-03. 347 See, e.g., Homegrown Act of 2021, H.R. 2649, 117th Cong. (2021); Common Sense Cannabis Reform for Veterans, Small Businesses, and Medical Professionals Act, H.R. 3105, 117th Cong. (2021); see also Marijuana Justice Act of 2019, H.R. 1456, 116th Cong. (2019); S. 597, 116th Cong. (2019). 348 See 1 U.S.C. § 109; Hurwitz v. United States, 53 F.2d 552, 552 (D.C. Cir. 1931) (applying then-applicable federal savings statute to prevent retroactive application of the repeal of a criminal law to a prosecution undertaken before the repeal); see also S. David Mitchell, In With the Old, Out With the New: Expanding the Scope of Retroactive Amelioration, 37 AM. J. CRIM. L. 1, 28-38 (2009). 349 Other legislative proposals from the 117th Congress would also have allowed for expungement or sealing of certain federal marijuana convictions. See, e.g., Marijuana Misdemeanor Expungement Act, H.R. 8557, (2022); Clean Slate Act of 2021, H.R. 2864, 117th Cong. (2021). Another proposal sought to facilitate expungement of state convictions. See Harnessing Opportunities by Pursuing Expungement Act of 2021, H.R. 6129, 117th Cong. (2021). See also, e.g., Congressional Research Service 36 link to page 16 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress would not affect other existing statutes and regulations that apply to the drug and thus would not bring aspects of the existing cannabis industry into compliance with federal laws such as the FD&C Act.350 Third, Congress might enact new legislation affecting marijuana in conjunction with any legislation removing it from the scope of the CSA. For instance, legislation introduced during the 116th Congress would have imposed new federal regulations on marijuana akin to those applicable to alcohol and tobacco.351 Fourth, reducing or removing federal restrictions on marijuana might be inconsistent with certain treaty obligations of the United States.352 The applicable treaties are not self-executing,353 meaning that they do not have the same status as judicially enforceable domestic law.354 However, failure to abide by its treaty obligations could expose the United States to diplomatic consequences.355 Marijuana Laws in America: Racial Justice and the Need for Reform: Hearing Before the House Comm. on the Judiciary, 116th Cong. 12-13 (2019) (statement of Marilyn J. Mosby). 350 See Press Release, FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on Signing of the Agriculture Improvement Act and the Agency’s Regulation of Products Containing Cannabis and Cannabis-Derived Compounds (Dec. 20, 2018), https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb--fda-commissioner-scott-gottlieb-md-signing-agriculture-improvement-act-and-agencys; see also CRS In Focus IF11250, FDA Regulation of Cannabidiol (CBD) Consumer Products, by Agata Bodie and Renée Johnson. Congress could also enact legislation to alter FDA regulation of cannabis-based products. For example, the Legitimate Use of Medicinal Marihuana Act, H.R. 171, 116th Cong. (2019), would have provided that neither the CSA nor the FD&C Act “shall prohibit or otherwise restrict” certain activities related to medical marijuana that are legal under state law. 351 See, e.g., Regulate Marijuana Like Alcohol Act, H.R. 420, 116th Cong. (2019). 352 See supra “International Treaty Obligations.” The United States is a party to the Single Convention on Narcotic Drugs of 1961 and the Convention on Psychotropic Substances of 1971. Both conventions require parties to impose certain controls on cannabis. However, in December 2020, the~~md-new-~~
~~steps-advance-agencys-continued-evaluation.~~
~~290 H.R. 171, 116th Cong. (2019).~~
~~291 See, e.g., Regulate Marijuana Like Alcohol Act, H.R. 420, 116th Cong. (2019).~~
~~292 United Nations Single Convention on Narcotic Drugs, 1961, art. 36, Mar. 30, 1961, 18 U.S.T . 1407.~~
~~293 United Nations Convention on Psychotropic Substances, art. 2(1)(7), Feb. 21, 1971, 32 U.S.T . 543.~~
~~294 Like the CSA, the international drug control treaties categorize controlled substances into schedules subject to~~
~~different requirements. Cannabis and cannabis resin were previously included in both Schedule I and Schedule IV of~~
~~the 1961 Convention, but in December 2020, t he~~ United Nations Commission on Narcotic Drugs voted to United Nations Commission on Narcotic Drugs voted to remove some of the restrictions on cannabis under the 1961 Convention~~remove~~
~~cannabis and cannabis resin from Schedule IV~~. . See Press Release, Press Release, United Nations ~~Com m ission~~Commission on Narcotic Drugs,
~~CND Votes on Recom m endations~~CND Votes on Recommendations for Cannabis and Cannabis-related Substances (Dec. 2, 2020). Nonetheless, cannabis and its derivatives remain subject to restrictions under the international drug control treaties that may be inconsistent with legalization of marijuana, particularly for recreational purposes. Specifically, cannabis and cannabis resin remain in Schedule ~~Substances~~ ~~(Dec. 2, 2020).~~
~~295 See, e.g., Bill Chappell, U.N. Commission Removes Cannabis from Its Most Strict Drug Control List, NPR, Dec. 2,~~
~~2020; Jariel Arvin, The UN Now Says Medical Weed is a Less Dangerous Drug , VOX, Dec. 3, 2020.~~
~~296 Cannabis and cannabis resin remain in Schedule~~ I of the 1961 Convention. United Nations Single Convention on I of the 1961 Convention. United Nations Single Convention on
Narcotic Drugs,Narcotic Drugs, 1961, List of Drugs1961, List of Drugs ~~Included~~ Included in Schedulein Schedule I, Mar. 30, 1961, 18 U.S.TI, Mar. 30, 1961, 18 U.S.T . 1407. . 1407. ~~T he~~ The 1961 Convention also 1961 Convention also
contains provisions imposing specific requirements on the cultivation of cannabis. contains provisions imposing specific requirements on the cultivation of cannabis. Id. art. 28. In art. 28. In addition, THC remains subject to control under the 1971 Convention~~addition, T HC remains~~
~~subject to control under the Convention on Psychotropic Substances of 1971~~. United Nations Convention on . United Nations Convention on
Psychotropic Substances, List of SubstancesPsychotropic Substances, List of Substances in Schedulein Schedule I, Feb.I, Feb. 21, 1971, 32 U.S.T21, 1971, 32 U.S.T . 543. . 543.
~~297 T he~~353 The Supreme Court has held, “Only ‘[i]f the treaty contains stipulations which are self-executing, that is, require no Supreme Court has held, “Only ‘[i]f the treaty contains stipulations which are self-executing, that is, require no
legislation to make them operative, [will] they have the force and effect of a legislative enactment.legislation to make them operative, [will] they have the force and effect of a legislative enactment. ’” Medellin v. ’” Medellin v. ~~T exas~~Texas, ,
552 U.S.552 U.S. 491, 505-06 (2008). Congress has made explicit findings that the Convention on Psychotropic Substances “491, 505-06 (2008). Congress has made explicit findings that the Convention on Psychotropic Substances “ is is
not self-executing, and the obligations of the United States thereunder may only be performed pursuant to appropriate not self-executing, and the obligations of the United States thereunder may only be performed pursuant to appropriate
legislation.” 21 U.S.C.legislation.” 21 U.S.C. § 801a(2). Because the enforcement provisions of the two treaties are similar, with neither § 801a(2). Because the enforcement provisions of the two treaties are similar, with neither
stating that it is self-executing, it appears the Singlestating that it is self-executing, it appears the Single Convention on Narcotic Drugs Convention on Narcotic Drugs is also also ~~is not self-executing.~~
~~Congressional Research Service~~
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~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~do not have the same status as judicial y enforceable domestic law ; for example, an individual~~
~~would not be subject to prosecution on the basis of the treaties without some implementing statute~~
~~such as the CSA.298 However, failure to abide by its treaty obligations could expose the United~~
~~States to diplomatic consequences.299~~
~~Clinical Research and Use of Schedule I Substances~~
~~Another issue that received significant attention during the 116th Congress was the possibility~~
~~that certain Schedule I controlled substances, especial y marijuana and psilocybin, may have~~
~~medical benefits. As a legal matter, Schedule I status limits researchers’ ability to conduct clinical~~
~~research involving these substances and patients’ ability to access such substances for medical~~
~~purposes.~~
~~Because substances in Schedule I have no accepted medical use under the CSA, it is only legal to~~
~~produce, dispense, and possess those substances in the context of federal y approved scientific~~
~~studies.300 In addition, federal law limits the use of federal funding for such research: a rider to~~
~~the appropriations bil for FY2021 provides that no appropriated funds may be used “for any~~
~~activity that promotes the legalization of any drug or other substance included in schedule I” of~~
~~the CSA, except “when there is significant medical evidence of a therapeutic advantage to the use~~
~~of such drug or other substance or . . . federal y sponsored clinical trials are being conducted to~~
~~determine therapeutic advantage.”301~~
~~Schedule I status under the CSA raises two key legal issues related to medical use and clinical~~
~~research. First, some commentators have expressed concerns that the CSA places too many~~
~~restrictions on research involving controlled substances, particularly Schedule I controlled~~
~~substances that might have a legitimate medical use.302 With respect to clinical research involving~~
~~marijuana specifical y, currently there is one farm that legal y produces marijuana for research~~

~~298 See Medellin, 552 U.S. at 527 (“A non-self-executing treaty, by definition, is one that was ratified with the~~
~~understanding that it is not to have domestic effect of its own force.”). For additional background on the legal effect of~~
~~self-executing and non-self-executing treaties, see CRS Report RL32528,~~ ~~International Law and Agreem ents: Their~~
~~Effect upon U.S. Law, by Stephen P. Mulligan, at 15.~~
~~299 See United Nations Single Convention on Narcotic Drugs, 1961, art. 14, Mar. 30, 1961, 18 U.S.T . 1407 (authorizing~~
~~the Narcotics Control Board to recommend to treaty signatories that they stop the export or import of drugs to a~~
~~signatory country that violates the treaty, or to publish a report on any matter related to enforcement of the treaty);~~
~~United Nations Convention on Psychotropic Substances, art. 19, Feb. 21, 1971, 32 U.S.T . 543 (same). Some~~
~~commentators have suggested that it is possible state laws decriminalizing marijuana already conflict with the United~~
~~States’ obligations under the treaties. See Brian M. Blumenfeld, Pacta Sunt Servanda~~ ~~State Legislation of Marijuana~~
~~and Subnational Violations of International Treaties: A Historical Perspective~~ ~~, 46 PEPP . L. REV. 69, 94-101 (2018)~~
~~(while acknowledging that the “ operative articles of the drug treaties do, in fact, leave room for debate,” concluding~~
~~that “the constitutional authority of the federal government to enforce marijuana prohibition in all fifty states is well-~~
~~settled American law,” and, because the “ United States’ administrative-discretionary measures have thus far failed to~~
~~deter numerous subnational actors from engaging in commercialized recreational marijuana activity, and instead have~~
~~created a sphere of tolerance for its growth, the United States will remain vulnerable to ce nsure from members of the~~
~~international community”); Jonathan Remy Nash,~~ ~~Doubly Uncooperative Federalism and the Challenge of U.S. Treaty~~
~~Com pliance, 55 COLUM. J. T RANSNAT’L L. 3, 21-23 (2016) (“ Limits on federal government power notwithstanding,~~
~~strict application of the doctrine of state responsibility would seem to mean that U.S. state actions have put the United~~
~~States in breach [of its treaty obligations].”).~~
~~300 See 21 U.S.C. § 823(f); see also Gonzales v. Raich, 545 U.S. 1, 14 (2004).~~
~~301 Pub. L. No. 116-260, Div. H, § 509 (2020).~~
~~302 See, e.g., Michael H. Andreae, et al., An Ethical Exploration of Barriers to Research on Controlled Drugs, AM. J.~~
~~BIOETH., Apr. 2016, at 5-6, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4849133/pdf/nihms-778176.pdf.~~
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~~link to page 28~~ ~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~purposes, and researchers have complained that marijuana from that source is deficient in both~~
~~quality and quantity.303~~
~~Second, there is a growing gulf between federal and state law with respect to Schedule I~~
~~controlled substances with potential medical benefits. The gap between federal and state~~
~~regulation of medical—and recreational—marijuana is discussed in greater detail above.304 But,~~
~~following the 2020 election, it appears that a gap may also be developing with respect to certain~~
~~other Schedule I substances. On November 3, 2020, voters in Oregon approved a bal ot measure~~
~~authorizing the use of psilocybin for medical purposes under state law.305 The same day, District~~
~~of Columbia voters passed a bal ot measure deprioritizing the enforcement of criminal~~
~~prohibitions on certain psychedelic plants and fungi.306 The District of Columbia measure is not~~
~~limited to medicinal use but was motivated in part by the possibility that psychedelic substances~~
~~may provide medical benefits.307 As with marijuana, these changes in D.C. and state law do not~~
~~alter the status of the affected Schedule I control ed substances under the federal CSA but~~
~~potential y raise similar legal issues.308~~
~~Congress has previously acted to facilitate research involving marijuana while also retaining strict~~
~~controls over the Schedule I controlled substance, but regulatory delays have reduced the~~
~~potential impact of that action. In 2015, Congress passed the Improving Regulatory Transparency~~
~~for New Medical Therapies Act, which imposed deadlines on DEA to issue notice of each~~
~~application to manufacture Schedule I substances for research and then act on the application.309~~
~~Although DEA stated in 2016 that it planned to grant additional licenses to grow marijuana for~~
~~research purposes, it has not yet done so.310 Perhaps prompted by litigation related to the delay,~~
~~DEA published a notice in the Federal Register in August 2019 announcing an ongoing “policy~~
~~review process to ensure that the [marijuana] growers program is consistent with applicable laws~~

~~303 See CRS Report R44782, The Marijuana Policy Gap and the Path Forward, coordinated by Lisa N. Sacco; Pet. for~~
~~Writ of Mandamus at 13-15, In re Scottsdale Research Inst., No. 19-1120 (D.C. Cir. June 6, 2019).~~
~~304 See supra “Marijuana Policy Gap.”~~
~~305 See Lizzy Acker, Oregon Becomes First State to Legalize Psychedelic Mushrooms, OREGOINAN, Nov. 3, 2020.~~
~~T hrough a separate ballot measure, Oregonians voted to decriminalize possession of small amounts of certain Schedule~~
~~I and II controlled substances, including cocaine, heroin, oxycodone and methamphetamines. See Cleve R. Wootson Jr.~~
~~and Jaclyn Peiser,~~ ~~Oregon Decrim inalizes Possession of Hard Drugs, as Four Other States Legalize Recreational~~
~~Marijuana, WASH. POST, Nov. 4, 2020.~~
~~306 See Justin Wm. Moyer, D.C. Voters Approve Ballot Question to Decriminalize Psychedelic Mushrooms, WASH.~~
~~POST, Nov. 3, 2020. T he D.C. ballot measure does not repeal criminal laws related to psychedelic pla nts and fungi but~~
~~rather provides that prosecution for the use and sale of such substances shall be “ among the Metropolitan Police~~
~~Department’s lowest law enforcement priorities.” Id. T he ballot measure appears to have been tailored to comply with a~~
~~federal appropriations rider that prohibits the District of Columbia from expending any federal funds “ to enact or carry~~
~~out any law, rule, or regulation to legalize or otherwise reduce penalties associated with the possession, use, or~~
~~distribution of any schedule I substance under the Controlled Substances Act [.]” Pub. L. No~~not self-executing. 354 See Medellin, 552 U.S. at 527 (“A non-self-executing treaty, by definition, is one that was ratified with the understanding that it is not to have domestic effect of its own force.”). For additional background on the legal effect of self-executing and non-self-executing treaties, see CRS Report RL32528, International Law and Agreements: Their Effect upon U.S. Law, by Stephen P. Mulligan, at 15. 355 See United Nations Single Convention on Narcotic Drugs, 1961, art. 14, Mar. 30, 1961, 18 U.S.T. 1407 (authorizing the Narcotics Control Board to recommend to treaty signatories that they stop the export or import of drugs to a signatory country that violates the treaty or to publish a report on any matter related to enforcement of the treaty); United Nations Convention on Psychotropic Substances, art. 19, Feb. 21, 1971, 32 U.S.T. 543 (same). Some commentators have suggested that it is possible that state laws decriminalizing marijuana already conflict with the United States’ obligations under the treaties. See Brian M. Blumenfeld, Pacta Sunt Servanda State Legislation of Marijuana and Subnational Violations of International Treaties: A Historical Perspective, 46 PEPP. L. REV. 69, 94-101 (2018); Jonathan Remy Nash, Doubly Uncooperative Federalism and the Challenge of U.S. Treaty Compliance, 55 COLUM. J. TRANSNAT’L L. 3, 21-23 (2016). Congressional Research Service 37 link to page 43 link to page 43 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress As an alternative to descheduling, some recent proposals would have maintained marijuana as a controlled substance but moved it to a less restrictive schedule, potentially allowing it to be dispensed by prescription for medical purposes.356 Congress could also continue to regulate marijuana as a Schedule I controlled substance subject to specific exceptions. For instance, several legislative proposals during the 116th Congress would have left marijuana in Schedule I but limited enforcement of federal marijuana law in states that have legalized marijuana.357 In the 117th Congress, the Small and Homestead Independent Producers Act of 2022 (H.R. 8825) would have allowed shipment of marijuana within and between states that have legalized the substance.358 Some recent proposals would have addressed specific legal consequences of marijuana’s Schedule I status. For example, the SAFE Banking Act of 2021, which passed the House in April 2021, sought to protect depository institutions that provide financial services to cannabis-related businesses from regulatory sanctions.359 Other proposals sought to ensure marijuana businesses’ access to insurance and other financial resources,360 facilitate federally approved clinical research involving marijuana,361 or enable veterans to access information about or use medical marijuana.362 Additional proposals would have removed collateral legal consequences of marijuana-related activities for individuals in areas such as immigration,363 gun ownership,364 and federally assisted housing.365 While most recent proposals would have relaxed federal regulation of marijuana, Congress could also impose more stringent controls. For instance, one recent proposal would have prohibited the use of benefits under the Temporary Assistance for Needy Families block grant at any store that offers marijuana for sale.366 Other proposals would seek to address the issues of marijuana impairment in the workplace367 or driving under the influence of marijuana and other substances.368 356 See, e.g., Marijuana 1-to-3 Act of 2021, H.R. 365, 117th Cong. (2012); Legitimate Use of Medicinal Marihuana Act, H.R. 171, 116th Cong. (2019); Compassionate Access Act, H.R. 715, 115th Cong. (2017). 357 State Cannabis Commerce Act, H.R. 3546, 116th Cong. (2019); S. 2030, 116th Cong. (2019); Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act), H.R. 2093, 116th Cong. (2019); S. 1028, 116th Cong. (2019); Responsibly Addressing the Marijuana Policy Gap Act of 2019, H.R. 1119, 116th Cong. (2019); S. 421, 116th Cong. (2019). 358 H.R. 8825, 117th Cong. (2022). 359 H.R. 1996, 117th Cong. (2021); S. 910, 117th Cong (2021). 360 CLAIM Act, H.R. 2068, 117th Cong. (2021); Ensuring Safe Capital Access for All Small Businesses Act of 2021, H.R. 2712, 117th Cong. (2021); CLIMB Act, H.R. 8200, 117th Cong. (2022); see also Ensuring Access to Counseling and Training for All Small Businesses Act of 2019, H.R. 3543, 116th Cong. (2019). 361 See, e.g., Developing and Nationalizing Key Cannabis Research Act of 2022, H.R. 8540, 117th Cong. (2022); Medical Marijuana Research Act, H.R. 5657, 117th Cong. (2021). See also infra “Clinical Research and Use of Schedule I Substances.” 362 See, e.g., Veterans Equal Access Act, H.R. 8197, 117th Cong. (2022); Fully Informed Veteran Act of 2021, H.R. 3601, 117th Cong. (2021); Veterans Medical Marijuana Safe Harbor Act, H.R. 2588, 117th Cong. (2021); Veterans Cannabis Use for Safe Healing Act, H.R. 430, 117th Cong. (2021). 363 Destigmatizing in Immigration Act, H.R. 1614, 117th Cong. (2021). 364 Gun Rights And Marijuana Act, H.R. 2830, 117th Cong. (2021). 365 Marijuana in Federally Assisted Housing Parity Act of 2021, H.R. 3212, 117th Cong. (2021). 366 Welfare for Needs not Weed Act, H.R. 4536 117th Cong. (2021). 367 H.R. 8591, 117th Cong. (2022). 368 Drug-Impaired Driving Education Act of 2021, H.R. 3675, 117th Cong. (2021); Impaired Driving Study Act of 2021, H.R. 3253, 117th Cong. (2021). Congressional Research Service 38 link to page 34 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress Clinical Research and Use of Schedule I Substances Another issue that received significant attention during the 117th Congress was the possibility that certain Schedule I controlled substances, especially marijuana and psilocybin, may have medical benefits. As a legal matter, Schedule I status limits researchers’ ability to conduct clinical research involving these substances and patients’ ability to access such substances for medical purposes. Because substances in Schedule I have no accepted medical use under the CSA, it is only legal to produce, dispense, and possess those substances in the context of federally approved scientific studies.369 In addition, federal law limits the use of federal funding for such research: a rider to the appropriations law for FY2023 provides that no appropriated funds may be used “for any activity that promotes the legalization of any drug or other substance included in schedule I” of the CSA, except “when there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or ... federally sponsored clinical trials are being conducted to determine therapeutic advantage.”370 Schedule I status under the CSA raises two key legal issues related to medical use and clinical research. First, some commentators have expressed concerns that the CSA places too many restrictions on research involving controlled substances, particularly Schedule I controlled substances that might have a legitimate medical use.371 Barriers to research may make it difficult both to harness potential medical benefits of those substances and to disprove possible false claims of benefits that may pose a public health risk. Second, there is a growing gulf between federal and state law with respect to Schedule I controlled substances with potential medical benefits. The gap between federal and state regulation of medical and recreational marijuana is discussed in greater detail above.372 But, more recently, it appears that a gap may be developing with respect to other Schedule I substances. On November 3, 2020, voters in Oregon approved a ballot measure authorizing the use of psilocybin for medical purposes under state law.373 The same day, District of Columbia voters passed a ballot measure deprioritizing the enforcement of criminal prohibitions on certain psychedelic plants and fungi.374 On November 8, 2022, voters in Colorado approved a ballot initiative legalizing the use of psilocybin and certain other substances by adults 21 or over and providing for the 369 See 21 U.S.C. § 823(f); see also Gonzales v. Raich, 545 U.S. 1, 14 (2004). 370 P.L. 117-328, div. H, § 509. 371 See, e.g., Michael H. Andreae, et al., An Ethical Exploration of Barriers to Research on Controlled Drugs, AM. J. BIOETH. 5-6 (Apr. 2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4849133/pdf/nihms-778176.pdf. 372 See supra “Federal and State Marijuana Regulation.” 373 See Lizzy Acker, Oregon Becomes First State to Legalize Psychedelic Mushrooms, OREGONIAN, Nov. 3, 2020. Through a separate ballot measure, Oregonians voted to decriminalize possession of small amounts of certain Schedule I and II controlled substances, including cocaine, heroin, oxycodone and methamphetamines. See Cleve R. Wootson Jr. and Jaclyn Peiser, Oregon Decriminalizes Possession of Hard Drugs, as Four Other States Legalize Recreational Marijuana, WASH. POST, Nov. 4, 2020. 374 See Justin Wm. Moyer, D.C. Voters Approve Ballot Question to Decriminalize Psychedelic Mushrooms, WASH. POST, Nov. 3, 2020. The D.C. ballot measure does not repeal criminal laws related to psychedelic plants and fungi but rather provides that prosecution for the use and sale of such substances shall be “among the Metropolitan Police Department’s lowest law enforcement priorities.” Id. The ballot measure appears to have been tailored to comply with a federal appropriations rider that prohibits the District of Columbia from expending any federal funds “to enact or carry out any law, rule, or regulation to legalize or otherwise reduce penalties associated with the possession, use, or distribution of any schedule I substance under the Controlled Substances Act[.]” P.L. 116-93 Div. C, § 909, 133 . 116-93 Div. C, § 909, 133
Stat. 2317 (2019). Stat. 2317 (2019).
~~307~~The District of Columbia measure is not limited to medicinal use but was motivated in part by the possibility that psychedelic substances may provide medical benefits. See Justin Wm. Moyer, Justin Wm. Moyer, D.C. Voters to Weigh in on ‘Magic Mushroom’ Decriminalization After Months-long
~~Cam paign~~Campaign, WASH. POST, Oct. 8, 2020. Congressional Research Service 39 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress establishment of centers for the therapeutic use of psilocybin and psilocyn.375 As with state marijuana laws, these changes in D.C. and state law do not alter the status of the affected Schedule I controlled substances under the federal CSA.376 In recent years, Congress has enacted legislation designed to facilitate research involving marijuana while also retaining strict controls over the substance. For over 50 years, DEA registered one farm in the United States to legally produce marijuana for research purposes, and researchers complained that marijuana from that source was deficient in both quality and quantity.377 In 2015, Congress passed the Improving Regulatory Transparency for New Medical Therapies Act, which imposed deadlines on DEA to issue notice of each application to manufacture Schedule I substances for research and then act on the application.378 Following years of delay and related court challenges,379 DEA published a notice in the Federal Register in August 2019 announcing~~, WASH. POST, Oct. 8, 2020. (“ In February, the D.C. Board of Elections approved the initiative after hearing~~
~~testimony from supporters who argued ibogaine, mescaline and the hallucinogen psilocybin, among other chemicals,~~
~~help people recover from post -traumatic stress syndrome and addict ion.”).~~
~~308 See CRS Legal Sidebar LSB10482,~~ ~~State Marijuana “Legalization” and Federal Drug Law: A Brief Overview for~~
~~Congress, by Joanna R. Lampe.~~
~~309 Pub. L. No. 114-89, 129 Stat.703 (2015); 21 U.S.C. § 823(i)(2). “Manufacturing” of controlled substances includes~~
~~growing marijuana. See, e.g., DEA, Bulk Manufacturer of Controlled Substances Applications: Bulk Manufacturers of~~
~~Marihuana, 84 Fed. Reg. 44,920 (Aug. 27, 2019) [hereinafter, DEA Notice].~~
~~310 See Pet. for Writ of Mandamus at 16, In re Scottsdale Research Inst., No. 19-1120 (D.C. Cir. June 6, 2019).~~
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~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~and treaties.”311 That notice announced~~ the agency’s intent to promulgate regulations governing the agency’s intent to promulgate regulations governing
the manufacture of marijuana for research purposes.the manufacture of marijuana for research purposes.380 It also provided notice of the 33 applications It also provided notice of the 33 applications
DEA had received to manufacture Schedule I DEA had received to manufacture Schedule I ~~control ed~~controlled substances for research purposes, and substances for research purposes, and
stated that DEA would review stated that DEA would review al all pending applications and grant “the number that the agency pending applications and grant “the number that the agency
determines is necessary to ensure an adequate and uninterrupted supply of the controlled determines is necessary to ensure an adequate and uninterrupted supply of the controlled
substances at issue under adequately competitive conditions.”substances at issue under adequately competitive conditions.”~~312~~381
In December 2020, DEA issued a final rule In December 2020, DEA issued a final rule ~~(based on its August 2019 proposal)~~ governing governing
registration for bulk marijuana manufacturers.registration for bulk marijuana manufacturers.~~313~~382 The final rule provides that the DEA The final rule provides that the DEA
Administrator “may grant an application for a registration to manufacture marihuana .Administrator “may grant an application for a registration to manufacture marihuana . . .. only if . only if
he determines that such registration is consistent with the public interesthe determines that such registration is consistent with the public interest” and with U.S. treaty obligations.383 ~~and with United States~~
~~obligations under the Single Convention.”314~~ The rule further provides that “[a] The rule further provides that “[a]l ll registered registered
manufacturers who cultivate cannabis manufacturers who cultivate cannabis ~~shal~~ shall deliver their total crops of cannabis” to DEA, and the deliver their total crops of cannabis” to DEA, and the
agency “agency “~~shal~~ shall purchase and take physical possession of such crops as soon as possible” and “have purchase and take physical possession of such crops as soon as possible” and “have
the exclusive right of importing, exporting, wholesale trading, and maintaining stocks [of the exclusive right of importing, exporting, wholesale trading, and maintaining stocks [of
cannabis] other than those held by registered manufacturers and distributors of medicinal cannabis] other than those held by registered manufacturers and distributors of medicinal
cannabis or cannabis preparations.”cannabis or cannabis preparations.”~~315~~384 The rule also The rule also ~~al ows~~allows DEA to delegate some of its DEA to delegate some of its
responsibilities, such as storage and trading of cannabis, to “appropriately registered persons.”responsibilities, such as storage and trading of cannabis, to “appropriately registered persons.”~~316~~
~~The effective date of the final rule is January 19, 2021.317 As of January 2021, DEA had not~~
~~registered any additional marijuana manufacturers.~~
~~As it did with the Improving Regulatory Transparency for New Medical Therapies Act, Congress~~
~~could pass further legislation to guide DEA’s consideration of applications to manufacture~~
~~marijuana for research purposes. For instance, the Medical Cannabis Research Act of 2019318~~
~~would have aimed to increase the number of licenses to produce cannabis for research purposes~~
~~by requiring DEA to approve at least three additional manufacturers within a year of passage.~~
~~Congress could also legislate more broadly to facilitate research involving controlled substances.~~
~~For example, a proposed amendment to the appropriations bil for FY2020 would have eliminated~~
~~the appropriations rider restricting the use of federal funding for research involving Schedule I~~
~~substances.319 That amendment, which would have applied to research involving al Schedule I~~
~~controlled substances, was intended to facilitate research involving not only marijuana but also~~
~~psilocybin, MDMA, and other Schedule I drugs that might have legitimate medical uses.320~~

311 Id.
~~312 DEA Notice at 44,921.~~
~~313~~385 After issuing the final rule, DEA began to issue registrations to additional manufacturers. As of January 2023, DEA has registered seven marijuana manufacturers.386 375 See Danica Jefferies, Colorado Just Legalized ‘Magic Mushrooms,’ an Idea That’s Growing Nationwide, CNBC (Nov. 12, 2022). 376 See CRS Legal Sidebar LSB10482, State Marijuana “Legalization” and Federal Drug Law: A Brief Overview for Congress, by Joanna R. Lampe. 377 See Pet. for Writ of Mandamus at 13-15, In re Scottsdale Research Inst., No. 19-1120 (D.C. Cir. June 6, 2019). 378 P.L. 114-89, 129 Stat.703 (2015); 21 U.S.C. § 823(i)(2). “Manufacturing” of controlled substances includes growing marijuana. See, e.g., DEA, Bulk Manufacturer of Controlled Substances Applications: Bulk Manufacturers of Marihuana, 84 Fed. Reg. 44,920 (Aug. 27, 2019) [hereinafter, DEA Notice]. 379 See generally Pet. for Writ of Mandamus, In re Scottsdale Research Inst., No. 19-1120 (D.C. Cir. June 6, 2019). 380 DEA Notice at 44,921. 381 Id. 382 See DEA, DEA, Controls To Enhance the Cultivation of Marihuana for Research in the United States, 85 Fed. Reg. , 85 Fed. Reg.
82,333 (Dec. 18, 2020). 82,333 (Dec. 18, 2020).
~~314~~383 Id. at 82,353. at 82,353.
~~315~~384 Id.
~~316~~385 Id. 386 DEA, Marihuana Growers Information, https://www.deadiversion.usdoj.gov/drugreg/marihuana.htm (last visited Jan. 3, 2022) Congressional Research Service 40 link to page 43 link to page 43 The Controlled Substances Act (CSA): A Legal Overview for the 118th ~~Id.~~
317 Id.
~~318 H.R. 601, 116th Cong. (2019).~~
~~319 H.Amdt. 321, 116th Cong. (2019). The amendment was not adopted.~~
~~320 See 165 Cong. Rec. H4612 (2019) (statement of Rep. Ocasio -Cortez) (“ I rise today to offer this critical bipartisan~~
~~amendment that will allow United States researchers to study and examine the extraordinary promise shown by several~~
~~schedule I drugs that have been shown in treating critical diseases, such as MDMA’s success in veteran PT SD,~~
~~psilocybin’s promise in treatment-resistant depression, or ibogaine’s effectiveness in opioid and other drug addiction.~~
~~Additionally, this will allow research into marijuana’s impact in cancer relief, seizure treatment, and more.”).~~
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~~COVID-19 Pandemic~~
~~The spread of COVID-19 in the United States beginning in early 2020 altered the daily lives of~~
~~mil ions of Americans and raised a wide range of legal issues.321 Issues relating to the CSA~~
~~include the supply of controlled substances used for treatment of COVID-19 and the prescription~~
~~of controlled substances via telemedicine.322~~
~~Supply of Controlled Substances~~
~~The COVID-19 pandemic has increased the demand for certain controlled substances for~~
~~legitimate medical purposes.323 In particular, Schedule II controlled substances such as fentanyl~~
~~and hydromorphone are used to relieve pain relief associated with intubation for patients on~~
~~ventilators.324 The CSA requires DEA to set aggregate production quotas for controlled~~
~~substances in Schedules I and II and for certain listed chemicals.325 DEA set the quotas for 2020~~
~~in December 2019.326 As COVID-19 spread in the United States in the spring of 2020, health care~~
~~providers became worried that existing supplies would be inadequate for the unprecedented~~
~~number of patients needing artificial ventilation and asked DEA to increase production quotas.327~~
~~In April 2020, DEA published a final order adjusting the 2020 production quotas for certain~~
~~Schedule II controlled substances, including fentanyl and hydromorphone, and the List I~~
~~chemicals ephedrine and pseudoephedrine.328~~
~~Increased production of controlled substances may raise concerns about increased potential for~~
~~diversion and abuse. The SUPPORT Act requires DEA to account for diversion when set ing~~
~~quotas for certain controlled substances, and DEA did so in revising the 2020 production~~
~~quotas.329 More general y, some worry that the pandemic wil lead to an increase in the misuse of~~
~~controlled substances as people across the country face il ness, anxiety, depression, and social~~
~~isolation due to the pandemic and related life changes.330 One July 2020 report described~~
~~“alarming spikes in drug overdoses” during the first months of the pandemic potential y driven by~~
~~“continued isolation, economic devastation and disruptions to the drug trade.”331~~

~~321 See CRS Legal Sidebar LSB10433, Legal Issues Related to the COVID-19 Outbreak: An Overview, coordinated by~~
~~Caitlain Devereaux Lewis.~~
~~322 For discussion of DEA’s role in responding to the COVID-19 pandemic, including DEA actions outside these two~~
~~areas, see CRS Insight IN11321, COVID-19: The Drug Enforcem ent Adm inistration’s Regulatory Role, by Lisa N.~~
~~Sacco.~~
~~323 See, e.g., Dan Levine,~~ ~~Exclusive: Opioid Supply Crunch for U.S. Coronavirus Patients Prompts Appeal to Relax~~
~~Lim its, REUTERS, Apr. 2, 2020.~~
~~324 See CRS Insight IN11321, COVID-19: The Drug Enforcement Administration’s Regulatory Role, by Lisa N. Sacco.~~
~~325 21 U.S.C. § 826(a); see also 21 C.F.R. § 1303.11.~~
~~326 See DEA,~~ ~~Established Aggregate Production Quotas for Schedule I and II Controlled Su bstances and Assessment of~~
~~Annual Needs for the List I Chem icals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2020~~ ~~, 84 Fed. Reg.~~
~~66,014, (Dec. 2, 2019).~~
~~327 See, e.g., Dan Levine,~~ ~~Exclusive: Opioid Supply Crunch for U.S. Coronavirus Patients Promp ts Appeal to Relax~~
~~Lim its, REUTERS, Apr. 2, 2020.~~
~~328 DEA,~~ ~~Adjustments to Aggregate Production Quotas for Certain Schedule II Controlled Substances and Assessment~~
~~of Annual Needs for the List I Chem icals Ephedrine and Pseudoephedrine for 2020, in Response to the Coronavirus~~
~~Disease 2019 Public Health Em ergency, 85 Fed. Reg. 20,302 (Apr. 10, 2020).~~
~~329 See id. at 20,304-05.~~
~~330 See, e.g., CDC,~~ ~~Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic — United~~
~~States, June 24–30, 2020, MORBIDITY AND MORTALITY WEEKLY REPORT, Aug. 14, 2020.~~
~~331 William Wan & Heather Long, “Cries for Help”: Drug Overdoses Are Soaring During the Coronavirus Pandemic,~~
~~Congressional Research Service~~
34

~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~These developments implicate both of the CSA’s core considerations: seeking to protect the~~
~~public health from the dangers of control ed substances while also ensuring that patients have~~
~~access to pharmaceutical controlled substances for legitimate medical purposes.332 Congress has~~
~~several means at its disposal to balance those interests. If Congress determined that the supply of~~
~~controlled substances was inadequate to address the COVID-19 pandemic or that the previous~~
~~increase in quotas had resulted in a surplus of controlled substances, it could legislatively alter~~
~~manufacturing quotas or enact legislation directing DEA to consider additional factors in setting~~
~~or revising quotas. Congress could also take steps to prevent misuse of controlled substances~~
~~without changing the national supply of such substances. For instance, the Emergency Support~~
~~for Substance Use Disorders Act would have authorized federal grants to support “overdose~~
~~prevention, syringe services programs, and other harm reduction services that address the harms~~
~~of drug misuse during the COVID-19 pandemic.”333~~
~~Telehealth Services~~
~~Another area where the COVID-19 pandemic has affected the CSA’s regulatory framework is~~
~~telemedicine.334 As the COVID-19 pandemic has limited individuals’ ability or desire to seek~~
~~medical care in person, the demand for telehealth services has increased.335 However, the CSA~~
~~limits the circumstances in which health care providers may prescribe controlled substances via~~
~~telemedicine. The CSA provides that most pharmaceutical controlled substances may be~~
~~dispensed only pursuant to a valid prescription,336 and a valid prescription must general y be~~
~~predicated on an in-person medical evaluation.337 A practitioner who has previously evaluated a~~
~~patient in person may prescribe the patient a controlled substance via telemedicine.338 However, a~~
~~practitioner who has not evaluated a patient in person may prescribe controlled substances via~~
~~telemedicine only in more limited circumstances, including at the request of a practitioner who~~
~~has conducted an in-person evaluation when that practitioner is unavailable, when a patient is~~
~~being treated in a CSA-registered facility, when the practitioner has obtained a special~~
~~telemedicine registration from DEA, during a medical emergency situation, or during a public~~
~~health emergency.339~~
~~With respect to the last option, the CSA authorizes the practice of telemedicine during a public~~
~~health emergency declared by the HHS Secretary under Section 319 of the Public Health Service~~

~~WASH. POST, July 1, 2020. See also Joseph Friedman et al.,~~ ~~Overdose-Related Cardiac Arrests Observed by Em ergency~~
~~Medical Services During the US COVID-19 Epidem ic, JAMA PSYCHIATRY, Dec. 3, 2020.~~
~~332 See id. §§ 801(1), (2).~~
~~333 S. 4058, 116th Cong. (2020).~~
~~334 T elemedicine is also subject to regulation under legal~~ Congress On December 2, 2022, President Biden signed into law the Medical Marijuana and Cannabidiol Research Expansion Act, which aimed to ease requirements for research involving marijuana and CBD.387 Among other things, the Act created specialized, expedited procedures for DEA approval of marijuana research and manufacture of marijuana for research purposes.388 Other proposals during the 117th Congress sought to facilitate federally approved clinical research involving marijuana389 or enable veterans to access information about or use medical marijuana.390 Congress could also legislate more broadly to facilitate research involving controlled substances. For example, a proposed amendment to an appropriations bill for FY2022 would have eliminated the appropriations rider restricting the use of federal funding to promote the legalization of Schedule I substances.391 That amendment was intended to facilitate research involving not only marijuana but also psilocybin, MDMA, and other Schedule I drugs that might have legitimate medical uses.392 Telehealth Services The spread of COVID-19 in the United States beginning in early 2020 altered the daily lives of millions of Americans and raised a wide range of legal issues.393 One area where the pandemic has had a lasting effect on the CSA’s regulatory framework is the practice of telemedicine.394 As the COVID-19 pandemic limited individuals’ ability or desire to seek medical care in person, the demand for telehealth services increased.395 However, the CSA limits the circumstances in which health care providers may prescribe controlled substances via telemedicine. The CSA provides that most pharmaceutical controlled substances may be dispensed only pursuant to a valid prescription,396 and a valid prescription must generally be predicated on an in-person 387 P.L. 117-215 (2022). 388 For additional discussion of the Act, see CRS Legal Sidebar LSB10859, Recent Developments in Marijuana Law, by Joanna R. Lampe. 389 See, e.g., Developing and Nationalizing Key Cannabis Research Act of 2022, H.R. 8540, 117th Cong. (2022); Medical Marijuana Research Act, H.R. 5657, 117th Cong. (2021). See also infra “Clinical Research and Use of Schedule I Substances.” 390 See, e.g., Veterans Equal Access Act, H.R. 8197, 117th Cong. (2022); Fully Informed Veteran Act of 2021, H.R. 3601, 117th Cong. (2021); Veterans Medical Marijuana Safe Harbor Act, H.R. 2588, 117th Cong. (2021); Veterans Cannabis Use for Safe Healing Act, H.R. 430, 117th Cong. (2021). 391 H.Amdt. 85, 117th Cong. (2021). The amendment was not adopted. 392 See 166 Cong. Rec. H4074 (2021) (statement of Rep. Alexandria Ocasio-Cortez) (stating that the appropriations rider “has, for a very long period of time, prevented and acted as a barricade to Federal research on certain substances—such as psilocybin, MDMA, and marijuana—in allowing us to research the applications and potential therapeutic applications of these drugs in the treatment of diseases such as PTSD, addiction, and depression.”). 393 See CRS Legal Sidebar LSB10433, Legal Issues Related to the COVID-19 Outbreak: An Overview, coordinated by Caitlain Devereaux Lewis. For discussion of DEA’s role in responding to the COVID-19 pandemic, see CRS Insight IN11321, COVID-19: The Drug Enforcement Administration’s Regulatory Role, by Lisa N. Sacco. 394 Telemedicine is also subject to regulation under legal authorities other than the CSA. See CRS authorities other than the CSA. See ~~CRS~~ Report R46239, Report R46239,
Telehealth and ~~Telem edicine~~Telemedicine: Frequently Asked Questions, by Victoria L. Elliott, by Victoria L. Elliott .
~~335~~. 395 Lisa M. Koonin, Lisa M. Koonin, et al., , Trends in the Use of Telehealth During the Emergence of the COVID-19 Pandemic —
United States, January–March 2020, MORBIDITY AND MORTALITY WEEKLY REPORT, Oct. 30, 2020. , MORBIDITY AND MORTALITY WEEKLY REPORT, Oct. 30, 2020.
~~336~~396 21 U.S.C. 21 U.S.C. § 829. § 829. ~~T he~~The CSA CSA does not mandate that Schedule Vdoes not mandate that Schedule V controlled substancescontrolled substances be distributedbe distributed by prescription, by prescription,
but suchbut such ~~substances~~ substances may be dispensedmay be dispensed only “only “ for a medical purpose.” for a medical purpose.” Id. § 829(c). As a practical matter, Schedule V § 829(c). As a practical matter, Schedule V
substancessubstances are almost alwaysare almost always ~~dispensed~~ dispensed pursuant to a prescription due to separate requirements under the FD&C Act or pursuant to a prescription due to separate requirements under the FD&C Act or
state law. state law. Cf, e.g., Ga. Code, Ga. Code Ann. § 16-13-29.2 (permitting the State Board of Pharmacy to allow the sale of Schedule Ann. § 16-13-29.2 (permitting the State Board of Pharmacy to allow the sale of Schedule
VV controlled substances without a prescription); Fl. Stat. Ann. § 893.08 (permitting the sale of Schedulecontrolled substances without a prescription); Fl. Stat. Ann. § 893.08 (permitting the sale of Schedule V controlled V controlled
substancessubstances over-the-counter by a registered pharmacist, if a prescription is not requiredover-the-counter by a registered pharmacist, if a prescription is not required under the FD&C Act). Congressional Research Service 41 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress medical evaluation.397 A practitioner who has previously evaluated a patient in person may prescribe the patient a controlled substance via telemedicine.398 By contrast, a practitioner who has not evaluated a patient in person may prescribe controlled substances via telemedicine only in more limited circumstances, including at the request of a practitioner who has conducted an in-person evaluation when that practitioner is unavailable, when a patient is being treated in a CSA-registered facility, when the practitioner has obtained a special telemedicine registration from DEA, during a medical emergency situation, or during a public health emergency.399 With respect to the last option, the CSA authorizes the use of telemedicine during a public health emergency declared by the HHS Secretary under Section 319 of the Public Health Service Act400 ~~under the FD&C Act).~~
~~337 21 U.S.C. § 829(e).~~
~~338 21 U.S.C. § 829(e)(2); see also DEA, COVID-19 Information Page,~~
~~https://www.deadiversion.usdoj.gov/coronavirus.html (accessed Dec. 2, 2020).~~
~~339 21 U.S.C. §§ 829(e)(2), 802(54).~~
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~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~

~~Act340~~ when the practice “involves patients located in such areas, and such controlled substances, when the practice “involves patients located in such areas, and such controlled substances,
as the [HHS] Secretary, with the concurrence of the Attorney General, designates.”as the [HHS] Secretary, with the concurrence of the Attorney General, designates.”~~341~~401 On January On January
31, 2020, the HHS Secretary issued a determination that a public health emergency exists under 31, 2020, the HHS Secretary issued a determination that a public health emergency exists under
the Public Health Service Act “[a]s a result of confirmed cases of 2019 Novel Coronavirus.”the Public Health Service Act “[a]s a result of confirmed cases of 2019 Novel Coronavirus.”~~342~~402
Subsequently, citing the CSA’s exception for telehealth services during a declared public health Subsequently, citing the CSA’s exception for telehealth services during a declared public health
emergency, DEA issued guidance on its website authorizing the use of telemedicineemergency, DEA issued guidance on its website authorizing the use of telemedicine~~.343 DEA~~
~~stated that on March 16, 2020, the HHS Secretary (with the concurrence of the acting DEA~~
~~Administrator) applied the public health emergency exception to “al~~ to prescribe “all schedule II-V controlled schedule II-V controlled
substances in substances in al all areas of the United States.”areas of the United States.”403 Thus, subject to applicable federal and state laws and Thus, subject to applicable federal and state laws and
other conditions,other conditions,~~344~~404 from March 16, 2020, until the expiration of the public health emergency from March 16, 2020, until the expiration of the public health emergency
related to COVID-19, DEA-registered practitioners anywhere in the United States may prescribe related to COVID-19, DEA-registered practitioners anywhere in the United States may prescribe
any pharmaceutical controlled substance via telemedicine without conducting an in-person any pharmaceutical controlled substance via telemedicine without conducting an in-person
medical evaluation.medical evaluation.~~345~~405
Numerous proposals before the 116th Numerous proposals before the 116th ~~Congress~~and 117th Congresses sought to increase access to telehealth care during sought to increase access to telehealth care during
the COVID-19 pandemic or maintain advances in telemedicine after the the COVID-19 pandemic or maintain advances in telemedicine after the pandemic ends. For instance, the Telehealth Extension and Evaluation Act would have extended expanded access to telehealth services for two years after the expiration of the COVID-19 emergency declaration.406 The Telehealth Act, introduced in the 116th Congress, would have 397 21 U.S.C. § 829(e). 398 21 U.S.C. § 829(e)(2); see also DEA, COVID-19 Information Page, https://www.deadiversion.usdoj.gov/coronavirus.html (accessed Dec. 2, 2020). 399 21 U.S.C. §§ 829(e)(2), 802(54). 400 42 U.S.C. § 247d. 401 21 U.S.C. § 802(54)(D). The statute provides that “~~pandemic ends. The~~
~~Telehealth Act, among other things, would have al owed practitioners to prescribe controlled~~
~~substances in Schedule III or Schedule IV based on a telehealth visit.346 A number of other~~
~~legislative proposals addressed regulation of telemedicine outside the scope of the CSA.347 If~~
~~similar proposals are introduced in the 117th Congress, legislators may consider whether they~~
~~would affect the prescribing of controlled substances via telemedicine and whether they should~~
~~include specific provisions related to the CSA.~~

~~340 42 U.S.C. § 247d.~~
~~341 21 U.S.C. § 802(54)(D). T he statute provides that “~~ such designation shall not be subject to the procedures prescribed such designation shall not be subject to the procedures prescribed
by subchapter II of chapter 5 of title 5,” by subchapter II of chapter 5 of title 5,” i.e., the , the ~~Administrative Procedure Act~~APA. . Id. § 802(54)(D)(ii). § 802(54)(D)(ii).
~~342~~402 Alex M. Azar II, Determination that a Public Health Emergency Exists (Jan. 31, 2020) Alex M. Azar II, Determination that a Public Health Emergency Exists (Jan. 31, 2020),
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019 -nCoV.aspx. -nCoV.aspx. ~~T he~~The determination has been renewed determination has been renewed
~~several~~multiple times, most recently in times, most recently in ~~October 2020~~January 2023. Alex M. Azar II, . Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists Determination that a Public Health Emergency Exists
~~(Oct. 2, 2020) https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19 -2Oct2020.aspx.~~
~~343~~(Jan. 11, 2023), https://aspr.hhs.gov/legal/PHE/Pages/covid19-11Jan23.aspx. 403 DEA, COVID-19 Information Page, https://www.deadiversion.usdoj.gov/coronavirus.html (accessed DEA, COVID-19 Information Page, https://www.deadiversion.usdoj.gov/coronavirus.html (accessed ~~Dec. 2, 2020).~~
~~344 T he~~ Jan. 6, 2023). 404 The applicable conditions for the use of telemedicine to prescribe controlled substances applicable conditions for the use of telemedicine to prescribe controlled substances ~~during~~ during the current public the current public
health emergency are: (1) health emergency are: (1) ~~t he~~the prescription is “ prescription is “ issued for a legitimate medical purpose by a practitioner acting in the issued for a legitimate medical purpose by a practitioner acting in the
usualusual course of his/her professional practice,” (2) course of his/her professional practice,” (2) ~~t he “~~ the “telemedicine communication is conducted usingtelemedicine communication is conducted using an audioan audio -visual, -visual,
real-time, two-way interactive communication system,” and (3) real-time, two-way interactive communication system,” and (3) ~~t he~~the prescribing practitioner is acting in accordance with prescribing practitioner is acting in accordance with
applicable federal and State laws. applicable federal and State laws.
~~345~~405 DEA specifically noted: “ DEA specifically noted: “ If the prescribing practitioner has previously conducted an in-person medical evaluation of If the prescribing practitioner has previously conducted an in-person medical evaluation of
the patient, the practitioner may issue a prescription for a controlled substance after having communicated with the the patient, the practitioner may issue a prescription for a controlled substance after having communicated with the
patient via telemedicine, or any other means, regardless of whether a publicpatient via telemedicine, or any other means, regardless of whether a public health emergency has been declaredhealth emergency has been declared by the by the
Secretary of Health and Human Services,Secretary of Health and Human Services, so long as the prescription is issuedso long as the prescription is issued for a legitimate medical purpose and the for a legitimate medical purpose and the
practitioner is acting in the usualpractitioner is acting in the usual course of his/her professional practice. In addition, for the prescription to be valid, the course of his/her professional practice. In addition, for the prescription to be valid, the
practitioner must comply with applicable Federal and State laws.” practitioner must comply with applicable Federal and State laws.”
~~346 H.R. 7992, 116th Cong. (2020). Legislative proposals to reform CSA regulation of telemedicine are not limited to~~
~~addressing the COVID-19 pandemic. For instance, the MET H Addiction Act, S. 2244, 116th Cong. (2019), would have~~
~~amended the CSA~~ 406 S. 3593, 117th Cong. (2022); H.R. 7573, 117th Cong. (2022). Congressional Research Service 42 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress allowed practitioners to prescribe controlled substances in Schedule III or Schedule IV based on a telehealth visit.407 A number of other legislative proposals in the 116th and 117th Congresses sought to address regulation of telemedicine outside the scope of the CSA.408 If similar proposals are introduced in the 118th Congress, legislators may consider whether they would affect the prescribing of controlled substances via telemedicine and whether they should include specific provisions related to the CSA. Cocaine Sentencing The 117th Congress also saw significant legal developments related to sentencing for cocaine offenses under the CSA.409 Congress placed cocaine in Schedule II when it enacted the CSA in 1970.410 The CSA as enacted did not distinguish between powder and crack cocaine. However, in response to concerns about a “crack epidemic” in the mid-1980s, Congress amended the CSA in 1986 to impose mandatory minimum sentences for certain offenses involving cocaine.411 While the minimum sentences applied to both powder and crack cocaine, the amount of each substance required to trigger the mandatory minimum varied by a ratio of 100 to 1.412 Offenses involving smaller amounts or an unspecified amount of cocaine (whether powder or crack) were also subject to criminal penalties but did not carry a mandatory minimum prison term. After the 1986 legislation was enacted, some commentators and stakeholders raised concerns that the disparity between the thresholds for powder and crack cocaine was too great and that crack offenders were disproportionately Black, creating a “perception of unfairness.”413 In response, Congress enacted the Fair Sentencing Act of 2010, which, among other things, raised the amounts of crack required to trigger mandatory minimum sentences, reducing the disparity between the thresholds for powder and crack cocaine to a ratio of approximately 18 to 1.414 The Fair Sentencing Act applied to future cases and cases that were pending on the date of enactment but did not apply to cases in which a sentence had already been imposed. 407 H.R. 7992, 116th Cong. (2020). Legislative proposals to reform CSA regulation of telemedicine are not limited to addressing the COVID-19 pandemic. For instance, the METH Addiction Act, S. 2244, 116th Cong. (2019), would have amended the CSA to allow community addiction treatment facilities and community mental health facilities to register to allow community addiction treatment facilities and community mental health facilities to register
to dispense controlled substances through the practice of telemedicine. to dispense controlled substances through the practice of telemedicine. See also Improving Access to Remote Improving Access to Remote
Behavioral Health Behavioral Health ~~T reatment~~Treatment Act of 2019, H.R. 4131, 116th Cong. (2019). Act of 2019, H.R. 4131, 116th Cong. (2019).
~~347~~ 408 See, e.g., , ~~Mental Health T elemedicine Expansion Act , H.R. 1301, 116th Cong. (2019); VA Mission T elehealth~~
~~Clarification Act , S. 3643, 116th Cong. (2020); T elehealth Modernization Act , H.R. 8727, 116th Cong. (2020).~~
~~Congressional Research Service~~
36

~~The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress~~
Ensuring Telehealth Expansion Act of 2021, H.R. 341, 117th Cong. (2021); Telehealth Expansion Act of 2021, H.R. 5981, 117th Cong. (2021); S. 1704, 117th Cong. (2021); Greater Access to Telehealth Act, H.R. 8489, 117th Cong. (2022); Advancing Telehealth Beyond COVID–19 Act of 2021, H.R. 4040. 117th Cong. (2021); Mental Health Telemedicine Expansion Act, H.R. 1301, 116th Cong. (2019); VA Mission Telehealth Clarification Act, S. 3643, 116th Cong. (2020); Telehealth Modernization Act, H.R. 8727, 116th Cong. (2020). 409 For additional discussion of cocaine sentencing under the CSA, see CRS Legal Sidebar LSB10611, Crack Cocaine Offenses and the First Step Act of 2018: Overview and Implications of Terry v. United States, by Michael A. Foster and Joanna R. Lampe; CRS In Focus IF11965, Cocaine: Crack and Powder Sentencing Disparities, by Lisa N. Sacco and Kristin Finklea. 410 Pub. L. No. 91-513, 84 Stat. 1236 (1970). 411 P.L. 99-70, 100 Stat. 3207-2 (1986). 412 For example, offenses involving 5 kilograms of cocaine powder or 50 grams of cocaine base (i.e., crack) carried a mandatory 10-year sentence, and offenses involving 500 grams of cocaine powder or 5 grams of cocaine base carried a mandatory five-year sentence. 413 Terry v. United States, 141 S. Ct. 1858, 1861 (2021) (quoting USSC, Special Report to the Congress: Cocaine and Federal Sentencing Policy 195-197 (Feb. 1995)). 414 P.L. 111-220, 124 Stat. 2373 (2010); see also 21 U.S.C. § 841. Congressional Research Service 43 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress In 2018, Congress enacted the First Step Act, which made the Fair Sentencing Act’s changes to crack sentences retroactive and permitted persons convicted and sentenced prior to passage of the Fair Sentencing Act to seek resentencing.415 The First Step Act applied to any “covered offense,” defined in part as “a violation of a Federal criminal statute, the statutory penalties for which were modified by” the Fair Sentencing Act provision that altered the crack-to-powder ratio for purposes of the relevant CSA offenses.416 Federal courts divided on the question of which statutory penalties were “modified by” the Fair Sentencing Act such that an offense subject to such penalties would constitute a “covered offense” and specifically whether offenders convicted under the lowest tier prior to changes made by the Fair Sentencing Act could seek retroactive resentencing.417 The Supreme Court resolved the split in a 2021 decision in Terry v. United States.418 In Terry, the Court concluded unanimously that the Fair Sentencing Act did not modify the statutory penalties for cocaine offenses under the lowest penalty tier.419 That holding means that crack offenders convicted prior to enactment of the Fair Sentencing Act may not seek resentencing if they were not subject to a mandatory minimum sentence. Following the Supreme Court’s decision in Terry, Members of the 117th Congress considered whether to expand resentencing opportunities for crack offenses committed before the enactment of the Fair Sentencing Act. It appears that at least some Members of Congress who supported the First Step Act intended the legislation to reach broadly and encompass all crack offenders.420 Additionally, some commentators have argued that it would be incongruous or arbitrary to allow resentencing for individuals convicted of offenses involving large amounts of crack while leaving in place sentences involving smaller amounts of the substance.421 More generally, the 117th Congress considered whether to alter or eliminate the disparity in sentencing thresholds between crack and powder cocaine. Congress originally imposed lower quantity thresholds for crack offenses based on concerns that crack was cheaper, more potent, more addictive, and overall more dangerous than other forms of cocaine.422 Some stakeholders argue that the current 18-to-1 ratio is not justified on scientific or public safety grounds and disproportionately affects Black offenders.423 If Congress elected to modify the threshold amounts 415 P.L. 115-391, 132 Stat. 5194 (2018). 416 Id. § 404. 417 Compare United States v. Smith, 954 F. 3d 446, 450 (1st Cir. 2020) and United States v. Woodson, 962 F. 3d 812, 816 (4th Cir. 2020) with United States v. Birt, 966 F. 3d 257, 264 (4th Cir. 2020). 418 141 S. Ct. 1858. 419 Id. at 1860. 420 For instance, four Senators who were lead sponsors and drafters of the 2018 legislation filed an amicus brief in Terry, arguing that the First Step Act “authorizes relief to everyone who had been sentenced for crack-cocaine offenses before the Fair Sentencing Act became effective, including individuals with low-level crack offenses” that did not carry mandatory minimum sentences. Br. of Amici Curiae Sens. Durbin, Grassley, Booker, and Lee, Terry v. United States, No. 20-5904 (Feb. 19, 2021). 421 See, e.g., Br. of Amius Curiae Ams. for Prosperity Foundation 20, Terry v. United States, No. 20-5904 (Feb. 19, 2021); Ekow Yankah, Unanimous Ruling on Crack-Cocaine Disparity is Heavy on Text, Light on History, SCOTUSBLOG (June 16, 2021), https://www.scotusblog.com/2021/06/unanimous-ruling-on-crack-cocaine-disparity-is-heavy-on-text-light-on-history/. 422 USSC, COCAINE AND FEDERAL SENTENCING POLICY 9 (May 2002). 423 See, e.g., Press Release, Nat’l Dist. Attys Assoc., Nation’s Largest Prosecutor Organization Endorses Ending the Disparity in Sentencing Between Crack and Powder Cocaine (Feb. 24, 2021). Congressional Research Service 44 The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress that trigger mandatory minimum sentences under the CSA, it could also consider whether those changes should apply retroactively. A proposal before the 117th Congress entitled the Eliminating a Quantifiably Unjust Application of the Law Act (EQUAL Act) sought to address both the retroactivity question presented in Terry and the sentencing disparity.424 With respect to the sentencing disparity between crack and powder cocaine, the EQUAL Act would have repealed the CSA provisions that impose mandatory minimum sentences for offenses involving crack.425 Because crack also falls within the broader category of cocaine, certain crack offenses would remain subject to mandatory minimum sentences. However, the quantity of crack required to trigger a mandatory minimum sentence would no longer be lower than the quantity of other forms of cocaine. With respect to retroactivity, the EQUAL Act would have authorized resentencing of any “defendant who, before the date of enactment of [the EQUAL] Act, was convicted or sentenced for a Federal offense involving cocaine base.”426 That language appears to include offenders who were convicted of crack offenses that did not carry mandatory minimum sentences.

Author Information

Joanna R. Lampe Joanna R. Lampe

Legislative Attorney Legislative Attorney

Disclaimer
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424 S. 79, 117th Cong. (2021); H.R. 1693, 117th Cong. (2021). 425 Id. § 2(a), (b). 426 Id. § 2(c)(2). Congressional Research Service Congressional Research Service
R45948 R45948 · VERSION 34 · UPDATED
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