• Background and Scope of the CSA
• Other Regulatory Schemes
• Classification of Controlled Substances
• Overview of Schedules
• Analogues and Listed Chemicals
• Scheduling Procedures
• Legislative Scheduling
• Administrative Scheduling
• Emergency Scheduling
• International Treaty Obligations
• Registration Requirements
• Entities Required to Register
• Obligations of Registrants
• Recordkeeping and Reporting
• Inspections
• Security
• Quotas
• Prescriptions
• Enforcement and Penalties
• Trafficking Provisions
• Prohibitions
• Enforcement and Penalties
• Legal Considerations for the 116thThe Controlled Substances Act (CSA): February 5, 2021 A Legal Overview for the 117th Congress Joanna R. Lampe The Controlled Substances Act (CSA) establishes a unified legal framework to regulate certain Legislative Attorney drugs Congress
• Opioid Crisis
• Analogue Fentanyl
• Marijuana Policy Gap
• Research Access

The Controlled Substances Act (CSA) imposes a unified legal framework to regulate certain drugs—whether medical or recreational, legally or illicitly distributed—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 drugs. Rather, it applies to specific substances and categories of substances that have been designated for control by Congress or through administrative proceedings. The statuteCSA also applies to controlled substance analogues that are intended to mimic the effects of controlled substances and to certain precursor chemicalschemicals commonly used in the manufacturing of controlled substances.

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 presentpose the greatest risk to the public health and safety are subject to the most stringent controls 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. MostMany substances subject toregulated under the CSA are also subject to other federal or state regulations, including the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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 applicable 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 under if required by the United States'’ international treaty obligations. In the alternative, Congress may place a substance under control by statute.

The CSA simultaneously aims to protect public health from the dangers of controlled substances diverted into the illicit market while also seeking to ensure that patients have access to pharmaceutical controlled substances for legitimate medical purposes 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 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 implementtake various measuressteps to prevent diversion and misuse of controlled substances. Trafficking provisions establish penalties for the production, 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 Justice to enforce the trafficking provisions of the CSAAct’s trafficking provisions. Violations of the registration provisions generally are not criminal offenses, but certain serious violations may result in criminal prosecutions, fines, and even short prison sentences. Violations 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 that wouldto amend the CSA in various ways. For example, after Congress passed several bills in recent years in response to the opioid crisis, additionalthe 116th Congress considered multiple proposals aimed at addressing the crisis are pending before the 116th Congressopioid crisis, including the John S. McCain Opioid Addiction Prevention Act (H.R. 1614, , S. 724), which would limithave limited practitioners'’ ability to prescribe opioids; the LABEL Opioids Act (H.R. 2732, , S. 1449), which would requirehave required prescription opioids to bear certain warning labels; and the Ending the Fentanyl Crisis Act of 2019 (S. 1724), which would increasehave increased criminal liability for illicit trafficking in the powerful opioid fentanyl. The 116th Congress has also considered 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, including the Stopping Overdoses of Fentanyl Analogues Act (H.R. 2935, S. 1622) and the Modernizing Drug Enforcement Act of 2019 (H.R. 2580). In addition, multiple recent proposals would seek to address the divergence between federal and state marijuana laws. For example, the Secure And Fair Enforcement Banking Act of 2019 (SAFE Banking Act) (H.R. 1595, S. 1200) would seek to protect depository institutions that provide financial services to cannabis-related businesses from regulatory sanctions, and the Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act) (H.R. 2093, S. 1028) would amend the CSA so that most provisions concerning marijuana do not apply to marijuana-related activities that comply with state law. Other proposals, such as the Legitimate Use of Medicinal Marihuana Act (H.R. 171) and the Marijuana Justice Act of 2019 (H.R. 1456, S. 597) could address the gap between federal and state law in the area of marijuana regulation by moving marijuana from Schedule I to a less restrictive schedule or remove marijuana from the CSA's schedules. Finally, recent legislative proposals would aim to facilitate clinical research involving controlled substances, particularly marijuana. These various proposals raise a number of legal questions as Congress contemplates whether to change the laws governing controlled substances.

P. In addition, multiple recent proposals sought to address the divergence between federal 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 controlled 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. Congressional Research Service link to page 4 link to page 6 link to page 8 link to page 8 link to page 10 link to page 11 link to page 11 link to page 12 link to page 13 link to page 14 link to page 15 link to page 15 link to page 17 link to page 17 link to page 17 link to page 18 link to page 18 link to page 19 link to page 19 link to page 20 link to page 20 link to page 21 link to page 23 link to page 23 link to page 26 link to page 28 link to page 34 link to page 37 link to page 37 link to page 38 link to page 9 link to page 40 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress Contents Background and Scope of the CSA .................................................................................... 1 Other Regulatory Schemes ............................................................................................... 3 Classification of Controlled Substances .............................................................................. 5 Overview of Schedules ............................................................................................... 5 Analogues and Listed Chemicals.................................................................................. 7 Scheduling Procedures ............................................................................................... 8 Legislative Scheduling .......................................................................................... 8 Administrative Scheduling..................................................................................... 9 Emergency Scheduling........................................................................................ 10 International Treaty Obligations............................................................................ 11 Registration Requirements.............................................................................................. 12 Entities Required to Register ..................................................................................... 12 Obligations of Registrants ......................................................................................... 14 Recordkeeping and Reporting .............................................................................. 14 Inspections ........................................................................................................ 14 Security ............................................................................................................ 15 Quotas .............................................................................................................. 15 Prescriptions...................................................................................................... 16 Enforcement and Penalties ........................................................................................ 16 Trafficking Provisions.................................................................................................... 17 Prohibitions ............................................................................................................ 17 Enforcement and Penalties ........................................................................................ 18 Legal Considerations for the 117th Congress ..................................................................... 20 Opioid Crisis .......................................................................................................... 20 Analogue Fentanyl................................................................................................... 23 Marijuana Policy Gap............................................................................................... 25 Clinical Research and Use of Schedule I Substances ..................................................... 31 COVID-19 Pandemic ............................................................................................... 34 Supply of Controlled Substances .......................................................................... 34 Telehealth Services ............................................................................................. 35 Figures Figure 1. CSA Scheduling Criteria ..................................................................................... 6 Contacts Author Information ....................................................................................................... 37 Congressional Research Service link to page 4 link to page 6 link to page 8 link to page 15 link to page 20 link to page 23 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress rescription drugs play a vital role in American public health. The Centers for Disease Control and Prevention (CDC) estimates that between 2011 and 2014 just under half of all during 2015 and 2016 over 45% of Americans had used one or more prescription drugs in the last 30 days.¹ On the other hand, unfettered1 But unfettered P access to drugs may pose serious public health risks. The CDC reports that in 20172018 over 70 67,000 Americans died of overdoses onof prescription and nonprescription drugs.² The Controlled Substances Act³2 The Controlled Substances Act3 (CSA or the Act) seeks to balance those competing interests.⁴ considerations.4 The CSA regulates controlled substances—prescription and nonprescription drugs and other substances that are deemed to pose a risk of abuse and dependence.⁵5 By establishing rules for the proper handling of controlled substances⁶substances6 and imposing penalties for any illicit il icit production, distribution, andor possession of such substances,⁷7 the Act seeks to protect the public health from the dangers of controlled substances while also ensuring that patients have access to pharmaceutical controlled substances for legitimate medical purposes.⁸

8 This report provides an overview of the CSA and select legal issues that have arisen under the Act, with a focus on legal issues of concern for the 116th117th Congress. The report first summarizes the history of the CSA and explains how the regulation of drugs under the CSA overlaps with other federal and state regulatory regimes.⁹9 It then outlines the categories—known as schedules—into which controlledfive main categories of substances subject to the Act are divided —known as schedules—and discusses how substances are added to the schedules.¹⁰10 The report next summarizesoutlines the CSA's ’s registration requirements, which apply togovern the activities of individuals and entities that register with the government to legally receive authorization to handle pharmaceutical controlled substances,¹¹11 before summarizing the CSA'’s criminal trafficking provisions, which apply to activities involving controlled substances that are not sanctionedcontrolled-substance-related activities that are not authorized under the Act.12 Final y under the Act.¹² Finally, the report outlines select legal issues for Congress related to the CSA, including issues related to the response to the opioid crisis, the control of analogues to the potent opioid fentanyl, the growing divergence between the treatment of marijuana under federal and state law, and the legal limits on clinical research involvingmedical use of certain controlled substances.¹³

, 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 See infra “Classification of Controlled Substances.” 11 See infra “Registration Requirements.” 12 See infra “T rafficking Provisions.” 13 See infra “Legal Considerations for the 117th Congress.” Congressional Research Service 1 link to page 5 link to page 5 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress narcotic drugs such asbegan with tariffs, import and export controls, and purity and labeling requirements applicable to narcotic drugs including opium and coca leaves and their derivatives.¹⁴14 With the passage of the Harrison Narcotics Tax Act of 1914, Congress began in earnest to regulate the domestic trade in narcotic drugs.¹⁵15 The Harrison Act provided forimposed federal oversight of the legal trade in narcotic drugs and imposed criminal penalties for illicit il icit trafficking in narcotics.¹⁶16 Over the course of the 20th century, the list of drugs subject to federal control expanded beyond narcotic drugs to include marijuana, depressants, stimulants, and hallucinogens.¹⁷

hal ucinogens.17 In 1970, Congress revamped federal drug regulation by enacting the Comprehensive Drug Abuse Prevention and Control Act of 1970.¹⁸ The Comprehensive Drug Abuse Prevention and Control Act.18 That act repealed nearly all al existing federal substance control laws and, for the first time, imposed a unified framework of federal controlled substance regulation.¹⁹ 19 Title II of the Comprehensive Drug Abuse Prevention and Control Act is known as the Controlled Substances Act.²⁰

20 The CSA regulates certain drugs²¹drugs21—whether medical or recreational, legally or illicitly legal y or il icitly distributed—that are consideredfound to pose a risk of abuse and dependence.²²22 In enacting the CSA, Congress recognized two competing interests related to drug regulation: on the. On one hand, many drugs "“have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people."²³”23 On the other hand, "illegal “il egal importation, manufacture, 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."²⁴”24 Accordingly, the Act simultaneously aims to protect public health from the dangers of controlled substances while also ensuring that patients have access to pharmaceutical access to controlled substances for legitimate medical purposes.

To accomplish those two goals, the statute creates two overlapping legal schemes. Registration provisions 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 certain information to regulators.²⁵25 Trafficking provisions establish penalties for the production, distribution, and possession of controlled substances outside the legitimate scope of the registration system.²⁶

The CSA does not apply to all drugs. As discussed below, substances must be specifically identified for control (either individually or as a class) to fall 26 14 T homas M. Quinn & Gerald T . McLaughlin, The Evolution of Federal Drug Control Legislation, 22 CATH. U.L. REV. 586, 589-93 (1973). 15 Pub. L. No. 63-223, 38 Stat. 785 (1915). 16 See Quinn & McLaughlin, supra note 14 at 593. 17 Id. at 600-03. 18 Pub. L. No. 91-513, 84 Stat. 1236 (1970). Congress has the authority to regulate controlled substances under the Commerce Clause. See Gonzales v. Raich, 545 U.S. 1, 15 (2004). 19 Quinn & McLaughlin, supra note 14 at 605. 20 T itle III of the Comprehensive Drug Abuse Prevention and Control Act is the closely related Controlled Substances Import and Export Act. See 21 U.S.C. §§ 951-971. 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. Congressional Research Service 2 link to page 19 link to page 8 link to page 10 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress 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.27within the scope of the Act.²⁷ For medical drugs, the CSA primarily applies to prescription drugs, not drugs available over the counter.²⁸28 Moreover, the statute does not apply to all al prescription drugs, but rather to a subset of those drugs deemed to warrant additional controls.²⁹29 As for nonpharmaceutical drugs, wellwel -known recreational drugs such as marijuana, cocaine,³⁰30 heroin, and lysergic acid diethylamide (LSD) are all al controlled substances, as are numerous lesser-known substances, some of which are identified only by their chemical formulas.³¹31 Some recreational drugs are not classified as federally federal y controlled substances.³²32 Alcohol and tobacco, which might otherwise qualify as drugs potentially potential y warranting control under the CSA, are explicitly excluded from the scope of the Act,³³33 as is hemp that meets certain statutory requirements.³⁴ Finally34 Final y, it is possible for legitimate researchers and illicit il icit drug manufacturers to formulate new drugs not contemplated by the Act. Those drugs may fall listed in any of the Act’s schedules. Even if those drugs are similar to existing controlled substances, they may fal outside the scope of the outside the scope of the CSA unless they are classified as controlled substances.³⁵

35 Other Regulatory Schemes

Many drugs classified as controlled substances subject to the CSA are also subject to other legal regimes. For example, all prescriptional pharmaceutical drugs, including those subject to the Act, are subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act).³⁶36 The U.S. Food and Drug Administration (FDA) is the agency primarily responsible for enforcing the FD&C Act, which which, among other things, prohibits the "“introduction or delivery for introduction into interstate commerce of any . . . drug . . . that is adulterated or misbranded."³⁷”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 considered misbranded,³⁹ as are prescription drugs that FDA has not approved, including imported drugs.⁴⁰ In addition, misbranding may include misrepresenting that a substance offered for sale is a brand-name drug (even if the seller believes the substance for sale is chemically identical to the brand-name drug).⁴¹ 27 Id. § 811. 28 Id. § 829; see also infra “Prescriptions.” 29 T he Drug Enforcement Administration (DEA) has estimated that 10%-11% of all drug prescriptions written in the United States are for controlled substances. See DEA, Dispensing of Controlled Substances to Residents at Long T erm Care Facilities, 75 Fed. Reg. 37,463, 37,464 (June 29, 2010). 30 Although cocaine is commonly considered a nonpharmaceutical drug, it has been placed in Schedule II, reflecting a finding that it has an accepted medical use. See 21 C.F.R. § 1308.12(b)(4); see also infra “ Overview of Schedules.” 31 T he full schedules are promulgated at 21 C.F.R. §§ 1308.11-1308.15. 32 For example, Salvia 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 CSA at this writing, although DEA has identified them as “ drugs of concern.” DEA, DRUGS OF ABUSE: A DEA RESOURCE GUIDE, 84-85 (2017). 33 See 21 U.S.C. § 802(6). 34 Id. § 802(16)(B)(i). Hemp and marijuana are both varieties of the cannabis plant. Hemp is defined as “ the plant Cannabis sativa L. and any part of that plant . . . with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” 7 U.S.C. § 1639(o). T he cannabis plant and most products produced from that plant remain controlled substances subject to the CSA, unless they meet the statutory definition of hemp. See 21 C.F.R. § 1308.11(d)(23). 35 See T he Countdown: Fentanyl Analogues & the Expiring Emergency Scheduling Order: Hearing Before the Sen. Comm. on the Judiciary, 116th Cong. 1, 4 (2019) (statement of the U.S. Dep’t of Justice) [hereinafter, DOJ T estimony]; see also CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea. In some cases, substances not specifically listed in the CSA’s schedules may qualify as controlled substance analogues. See infra “ Analogues and Listed Chemicals.” 36 21 U.S.C. §§ 301-399i. 37 Id. § 331(a). Congressional Research Service 3 link to page 28 link to page 7 link to page 7 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress advertising, or promotion “is false or misleading in any particular.”38 Unlabeled drugs are 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 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 poisonous or deleterious substance,"” or its strength, quality, or purity is not as represented.⁴²

41 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 danger to the public welfare.⁴³42 The FD&C Act, by contrast, is a consumer protection statute that seeks to protect consumers from obtaining unsafe or ineffectiveseeks to prevent harm to consumers who obtain drugs (and other public health products) through commercial channels.⁴⁴43 Any person or organization that produces, distributes, 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.

With respect to both pharmaceutical and nonpharmaceutical drugs, many drugs subject to the ActCSA are also subject to state drug laws.⁴⁵controlled substance laws.44 State substance control laws often mirror federal law and are relatively uniform across jurisdictions because almost all al states have adopted a version of a model statute cal ed the Uniform Controlled Substances Act (UCSA).⁴⁶ 45 However, states are free to modify the UCSA, and have done so to varying extents.⁴⁷46 Moreover, the model statute does not specify sentences for violations, so penalties for state controlled substance offenses vary widely.⁴⁸

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.⁴⁹ 48 For example, some states have controlled the fentanyl analogues benzylfentaylbenzylfentanyl and thenylfentanyl, but those substances are not currently subject to federal control.⁵⁰ Second, states scheduled under the CSA.49 Second, states 38 Id. § 352. 39 See United States v. Wood, 8 F.3d 33, 1993 WL 425948 (T able) at *3 (9th Cir. 1993). 40 See, e.g., In re Canadian Import Antitrust Litigation, 470 F.3d 785, 788 -90 (8th Cir. 2006); United States v. Patwardhan, 422 Fed. App’x. 614, 616-17 (9th Cir. 2011). Misbranding also includes misrepresenting that a substance offered for sale is a brand-name drug. See, e.g., United States v. Xin He, 405 Fed. App’x 220, 221 (9th Cir. 2010). 41 21 U.S.C. § 351. 42 See id. § 801(1) (“ The illegal importation, manufacture, 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.”). 43 See, e.g., United States v. Kordel, 397 U.S. 1, 11 (1970) (invoking the “ public interest in protecting consumers throughout the Nation from misbranded drugs”); see also CRS Report R43609, Enforcem ent of the Food, Drug, and Cosm etic Act: Select Legal Issues, by Jennifer A. Staman. 44 ALEX KREIT, CONTROLLED SUBSTANCES: CRIME, REGULATION, AND POLICY 628 (2013). 45 Richard L. Braun, Uniform Controlled Substances Act of 1990, 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 Congressional Research Service 4 link to page 9 link to page 7 link to page 28 link to page 15 link to page 20 link to page 11 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress 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.⁵¹50 Third, states may decide not to impose state controls on substances subject to the CSA, or they may choose to impose modified versions of federal controls at the state level.⁵² Crucially51 Crucial y, however, the states cannot alter federal law, and when state and federal law conflict, the federal law controls.⁵³52 Thus, when states "legalize" or "decriminalize" a federally“legalize” or “decriminalize” a federal y controlled substance (as many have done recently with respect to marijuana), the sole result is that the substance is no longer controlled under state law.⁵⁴.53 Any federal controls remain in effect and potentially potential y enforceable in those states.⁵⁵

54 Classification of Controlled Substances

The heart of the CSA is its system for classifying controlled substances, as nearly all al the obligations and penalties that the Act establishes flow from the classification system.⁵⁶55 Drugs become subject to the CSA by being placed in one of five lists, referred to as "“schedules."⁵⁷”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.⁵⁸57 As discussed below, scheduling decisions by Congress and DEA follow different procedures.⁵⁹

58 Overview of Schedules

The CSA establishes five categories of controlled substances, referred to as Schedules I through V.59V.⁶⁰ The schedule on which a controlled substance is placed determines the level of restriction imposed on its production, distribution, and possession, as well wel as the penalties applicable to any improper handling of the substance.⁶¹ As60 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). Benzylfentanyl and thenylfentanyl were temporarily placed under federal control in 1985, but the temporary scheduling expired in 1986, and DEA has determined that the substances are “essentially inactive, with no evidence of abuse potential.” DEA, Correction of Code of Federal Regulat ions: Removal of T emporary Listing of Benzylfentanyl and T henylfentanyl as Controlled Substances, 75 Fed. Reg. 37,300, 37,300 (June 29, 2010). 50 Kreit, supra note 44 at 629. 51 Id. at 628 (citing Ruiz-Vidal v. Gonzales, 473 F.3d 1072, 1078 (9th Cir. 2007)). 52 U.S. CONST. art. VI, cl. 2 (“ the laws of the United States . . . shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the Constitution or laws of any State to the contrary notwithstanding”). 53 See Gonzales v. Raich, 545 U.S. 1, 29 (2005). 54 DEA and DOJ sometimes do not enforce federal controlled substances law with respect to state-legal activities that violate the CSA. Reasons for this include the exercise prosecutorial discretion and the existence of appropriations riders limiting enforcement of the CSA in some circumstances. For further discussion of the relationship between state legalization of controlled substances and the CSA, see the “ Marijuana Policy Gap” section. 55 For further discussion of 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. § 823 (registration requirements); id. § 829 (prescription requirements); id. §§ 841-842 (prohibitions and penalties). Congressional Research Service 5 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress control by regulation, the agency assigns Figure 1 describes, each controlled substance is assigned to a schedule based on its medical utility and its potential for abuse and dependence.

Figure 1. CSA Scheduling Criteria

Notes: Notes: 1 21 U.S.C. § 812(b)(1). 2 2 The CSA generallygeneral y uses the word "marihuana"“marihuana” to refer to the cannabis plant and its derivatives. This report uses the more widely accepted spelling, "marijuana," spel ing, “marijuana,” unless quoting other sources. 3 3 For the full ful list of substances in Schedule I, see 21 C.F.R. § 1308.11. 4 4 21 U.S.C. § 812(b)(2). 5 5 The CSA distinguishes between prescription fentanyl and illicit il icit fentanyl. Prescription fentanyl and several related medications are in Schedule II. Numerous nonprescription fentanyl analogues are in Schedule I. 6 6 For the full ful list of substances in Schedule II, see 21 C.F.R. § 1308.12. 7 7 21 U.S.C. § 812(b)(3). 8 8 For the full ful list of substances in Schedule III, see 21 C.F.R. § 1308.13. 9 9 21 U.S.C. § 812(b)(4). 10 For the full ful list of substances in Schedule IV, see 21 C.F.R. § 1308.14 11 21 U.S.C. § 812(b)(5). 12 For the full ful list of substances in Schedule V, see 21 C.F.R. § 1308.15.

Congressional Research Service 6 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress 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 stringent.⁶²61 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 federallyfederal y approved scientific studies.⁶³

62 Analogues and Listed Chemicals

In addition to the controlled substances listed in Schedules I through V, the CSA also regulates (1) (1) controlled substance analogues and (2) listed chemicals.

Under the CSA, a controlled substance analogue is a substance that FDA has not approved and that is not specificallyspecifical y scheduled under the Act, but that has (1) a chemical structure substantially substantial y similar to that of a controlled substance in Schedule I or II, or (2) an actual or intended effect that is “substantial yis "substantially similar to or greater than the stimulant, depressant, or hallucinogenichal ucinogenic effect on the central nervous system of a controlled substance in schedule I or II."⁶⁴”63 A substance that meets those criteria and 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 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 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 have. Listed chemicals subject to the CSA are precursor chemicals that are general y not intended for human consumption but can be used to produceSchedule I.⁶⁵

Listed chemicals subject to the CSA are precursor chemicals for 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. 63 Id. § 802(32). 64 Id. § 813(a). 65 See 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, considering evidence that “ the defendants were attempting to manufacture substances designed for human consumption and designed to produce amphetamine-like effects when ingest ed”). It is, however, possible for a substance to be both a listed chemical and a controlled substance analogue. See 21 U.S.C. § 802(32)(B) (“ 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 that the chemical is a controlled substance analogue.”); see also United States v. Fisher, 289 F.3d 1329, 1335 -36 (11th Cir. 2002) (finding that a listed chemical could be treated as a controlled substance analogue if intended for human consumption). Congressional Research Service 7 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress  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
• 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

67 List I chemicals include substances such as ephedrine, white phosphorous, and iodine, which are used to produce methamphetamine, as well wel as chemicals used to manufacture LSD, MDMA (also known as “ecstasy” or “molly”), and other drugs.⁶⁸68 List II chemicals include, among others, solvents such as acetone, hydrochloric acid, and sulfuric acid.⁶⁹

69 Listed chemicals are subject to some of the same controls as controlled substances.⁷⁰controls similar to those that apply to controlled substances.70 In addition, entities that sell sel listed chemicals must record the transactions, report them to regulators, and comply with statutory limits on sales to a single purchaser.⁷¹

71 There are a number of differences between how controlled substance analogues and listed chemicals are regulated. chemicals are regulated. A key difference between controlled substance analogues and listed chemicals is that a substance does not qualify for control as an analogue unless it is intended for human consumption as a substitute for a controlled substance, while listed chemicals generally are not intended for human consumption standing alone but are used as ingredients in the manufacture of controlled substances.⁷² In addition, listed chemicals include only specific substances identified for control under the CSA by statute or rulemaking.⁷³72 By contrast, controlled substance analogues need not be individually individual y scheduled; they need only satisfy the statutory criteria.⁷⁴

73 Scheduling Procedures

Substances may be added to or removed from a schedule or moved to a different schedule through agency action or by legislation.⁷⁵

74 As described below, the procedures for modifying a substance’s scheduling differ depending on whether Congress or DEA makes the change. Legislative Scheduling Legislative Scheduling

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 it from control. The procedural requirements for administrative scheduling discussed in the following section do not apply to legislative scheduling. Thus, Congress may use its legislative scheduling power to respond quickly to regulate a drug that posesa drug it views as posing an urgent concern. For example, the Synthetic Drug Abuse Prevention Act of 2012 permanently added two synthetic cathinones (central nervous system stimulants) and certain cannabimimetic substances (commonly referred to as synthetic marijuana) to Schedule I.⁷⁶

66 21 C.F.R. § 1300.02(b18). 67 Id. § 1300.02(b19). 68 Id. § 1310.02(a). 69 Id. § 1310.02(b). 70 See, e.g., 21 U.S.C. § 823(h) (requiring DEA registration to distribute List I chemicals); id. § 841(c) (imposing criminal penalties for, among other things, “possess[ing] or distribut[ing] a listed chemical knowing, or having reasonable cause to believe, that the listed chemical will be used to manufacture a controlled substance except as authorized by” the CSA); id. § 842(a) (imposing civil and criminal penalties for certain unauthorized r etail sales of listed chemicals). 71 Id. § 830. 72 21 U.S.C. §§ 802(34), (35). 73 See, e.g., Hofstatter, 8 F.3d at 321-22 (upholding against Fifth Amendment vagueness challenge the statutory criteria for controlled substance analogues). 74 See 21 U.S.C. § 811; United States v. Ways, 832 F.3d 887, 893 (8th Cir. 2016) (summarizing the addition of certain substances to Schedule I by legislation). Congressional Research Service 8 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress (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 Administrative Scheduling Administrative Scheduling

DEA makes scheduling decisions through a complex process requiring participation by other agencies and the public.⁷⁷77 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 any interested party."⁷⁸”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 "“the grounds upon which the petitioner relies are not sufficient to justify the initiation of proceedings."⁷⁹ of proceedings.”79 Denial of a petition to initiate scheduling proceedings is subject to judicial review, but courts will wil overturn a denial only if it is arbitrary and capricious.⁸⁰

80 Before initiating rulemaking proceedings, DEA must request a scientific and medical evaluation of the substance at issue from the Secretary of HHS.⁸¹81 The HHS Secretary has delegated the authority to prepare the scientific and medical evaluation to FDA.⁸²82 In preparing the evaluation, FDA considers factorsa number of factors, including the substance'’s potential for abuse and dependence, 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 substance is an immediate precursor of an existing controlled substance.⁸³83 Based on those factors, FDA makes a recommendation on whether the substance should be controlled and, if so, in which schedule it should be placed.⁸⁴84 FDA'’s scientific and medical findings are binding on DEA.⁸⁵ And85 Furthermore, if FDA recommends against controlling the substance, DEA may not schedule it.⁸⁶

Upon receipt of FDA's report, the DEA Administrator evaluates all 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. Congressional Research Service 9 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress 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 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.⁸⁸88 DEA scheduling decisions are subject to notice-and-comment rulemaking,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.⁸⁹

final.90 The DEA Administrator'’s decision whether to schedule, reschedule, or deschedule a substance through the ordinary administrative process is subject to judicial review.⁹⁰91 Such review is generallygeneral y deferential: courts accept DEA'’s interpretation of the CSA as long as the interpretation of ambiguous statutory text is reasonable,⁹¹92 and the CSA provides that the DEA Administrator's ’s findings of fact are "conclusive"“conclusive” on judicial review if the findings are supported by substantial evidence.⁹²

93 Overal , courts wil set aside DEA action “only if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’”94 Emergency Scheduling Emergency Scheduling

Ordinary DEA scheduling decisions are made through notice-and-comment rulemaking and can take years to consider and finalize.⁹³95 Recognizing that in some cases faster scheduling may be appropriate, Congress amended the CSA through the Comprehensive Crime Control Act of 1984⁹⁴ to allow198496 to al ow the DEA Administrator to place a substance in Schedule I temporarily when "“necessary to avoid an imminent hazard to the public safety."⁹⁵ Further amendments enacted in the Synthetic Drug Abuse Prevention Act of 2012 extended the maximum length of the temporary scheduling period.⁹⁶”97 Before issuing a temporary scheduling order, the DEA Administrator must provide 30 days'’ notice to the public and the Secretary of HHS stating the basis for temporary scheduling.⁹⁷98 In issuing a temporary scheduling order, the DEA 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 of abuse; and the risk to the public health.⁹⁸99 The DEA Administrator must also consider any comments from the Secretary of HHS.⁹⁹

A100 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 v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991) (citing Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 843 -45 (1984)). 93 21 U.S.C. § 877. 94 See, e.g., Ams. for Safe Access v. DEA, 706 F.3d 438, 449 (D.C. Cir. 2013) (quoting 5 U.S.C. § 706(2)(A)). 95 See, e.g., Washington v. Barr, 925 F.3d 109, 120 (2d Cir. 2019) (“ Plaintiffs document that the average delay in deciding petitions to reclassify drugs under the CSA is approximately nine years.”). 96 Pub. L. No. 98-473, 98 Stat. 1976 (1984). 97 21 U.S.C. § 811(h)(1). 98 21 U.S.C. § 811(h)(1). 99 Id. § 811(h)(3). 100 Id. § 811(h)(4). Congressional Research Service 10 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress 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.¹⁰⁰102 A temporary scheduling order is vacated once permanent scheduling proceedings are completed with respect to the substance at issue.¹⁰¹103 The CSA provides that emergency scheduling orders are not subject to judicial review.¹⁰²

104 DEA has recently used its emergency scheduling power to temporarily control certain analogues to the opioid fentanyl¹⁰³fentanyl105 and several synthetic cannabinoids.¹⁰⁴

106 International Treaty Obligations

The United States is a party to the Single Convention on Narcotic Drugs of 1961, whichwhic h was designed to establish effective control overcontrols on the international and domestic traffic in narcotics, coca leaf, cocaine, and marijuana.¹⁰⁵ That107 The treaty requires signatories, among other things, to criminalize "any “cultivation, production, manufacture, extraction, preparation, possession, offering, offering for sale, distribution, purchase, sale, . . . importation and exportation of drugs" contrary to the Convention.¹⁰⁶

” that are subject to the Convention, except to the extent the Convention authorizes such activities.108 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 hallucinogens.¹⁰⁷hal ucinogens.109 The Convention on Psychotropic Substances requires parties to adopt various controls applicable to controlled substances, including mandating licenses for manufacture and distribution, requiring prescriptions for dispensing such substances, and adopting measures "“for the repression of acts contrary to laws or regulations"” adopted pursuant to treaty obligations.¹⁰⁸

110 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 under the schedule he deems most appropriate to carry out such obligations."¹⁰⁹”111 Scheduling 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 procedures outlined for regular administrative scheduling.¹¹⁰

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 Placement of Fentanyl-Related Substances in Schedule I, 83 Fed. 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 Placement of 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 into Schedule I, 84 Fed. Reg. 15,505 (Apr. 16, 2019). 107 See United Nations Single Convention on Narcotic Drugs, 1961, Mar. 30, 1961, 18 U.S.T . 1407, preamble (stating the parties’ desire “ to conclude a generally acceptable international convention replacing existing treaties on narcotic drugs, limiting such drugs to medical and scientific use”). 108 Id. art. 36. 109 United Nations Convention on Psychotropic Substances, Feb. 21, 1971, 32 U.S.T . 543. 110 Id. art. 2(1)(7). 111 21 U.S.C. § 811(d)(1). 112 Id. Congressional Research Service 11 link to page 17 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress Registration Requirements 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.¹¹¹113 The goal of the regulatory scheme is to create a "“closed system"” of distribution in which only authorized handlers may distribute controlled substances.¹¹²114 Central to the closed system of distribution is the requirement that individuals or entities that work with controlled substances register with DEA. Those covered entities, which include manufacturers, distributors, practitioners, and pharmacists,¹¹³115 are referred to as registrants.¹¹⁴116 As DEA has described the movement of a pharmaceutical controlled substance from the manufacturer to the patient,

[A] controlled substance, after being manufactured by a DEA -registered manufacturer, may be transferred to a DEA-registered distributor for subsequent distribution to a DEA- -registered retail pharmacy. After a DEA-registered practitioner, such as a physician or a dentist, issues a prescription for a controlled substance to a patient . . . , that patient can fill 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 be DEA registrants, or to be exempted from the requirement of registration, to participate in the process.¹¹⁵

117 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 suspicious orders to prevent misuse and diversion.¹¹⁶118 Thus, the registration system aims to ensure 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.¹¹⁷

119 Entities Required to Register

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 applies.¹¹⁸ applies.120 Significantly, the CSA exempts from registration individual consumers of controlled control ed substances, such as patients and their family members, whom the actAct refers to as "“ultimate 113 See id. § 822. 114 DEA, Electronic Prescriptions for Controlled Substances, 75 Fed. Reg. 16 ,235, 16,237 (Mar. 31, 2010). 115 21 U.S.C. § 822(a). 116 21 C.F.R. § 1300.02(b)(24). 117 DEA, Disposal of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration, 74 Fed. Reg. 3480, 3481 (Jan. 21, 2009). 118 See infra “Obligations of Registrants.” 119 See DEA, Definition and Registration of Reverse Distributors, 70 Fed. Reg. 22 ,591, 22,591 (May 2, 2005). 120 21 U.S.C. § 822; 21 C.F.R. Part 1301. See also 21 U.S.C. § 957 (section of the Controlled Substances Import and Export Act imposing registration requirements for importers and exporters of controlled substances). Congressional Research Service 12 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 ultimate users."¹¹⁹ 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."¹²⁰

Manufacturers and distributors of controlled substances, such as pharmaceutical companies, must register with DEA annually.¹²¹annual 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.¹²²124 Registrations specify the extent to which 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, 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 manufactured, distributed, imported, exported, or dispensed.¹²³ And certain activities can give rise to additional registration requirements. For instance, a special registration is required to operate125 Special registration is required for certain activities, including operating an opioid treatment program such as a methadone clinic.¹²⁴

126 The CSA directs the DEA Administrator to grantissue a registration if it would be consistent with the public interest, outliningand the Act outlines the criteria the DEA Administrator must consider when evaluating the public interest.¹²⁵127 The criteria vary depending on (1) whether the applicant is a manufacturer, distributor, researcher, or practitioner, and (2) the classification of the controlled substances that are the focus of the application. However, the requirements generallygeneral y serve to help DEA determine whether the applicant has demonstrated the capacity to maintain effective controls against diversion and comply with applicable laws.¹²⁶

128 The registration of an individual or organization expires at the end of the registration period unless it is renewed.¹²⁷129 Registration also ends when the registrant dies, ceases legal existence, or discontinues business or professional practice.¹²⁸130 A registration cannot be transferred to someone else without the express, written consent of the DEA Administrator.¹²⁹

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 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); see also CRS In Focus IF10219, Opioid Treatment Programs and Related Federal Regulations, by Johnathan H. Duff. 127 Id. § 823(a)-(f). 128 Id. 129 21 C.F.R. §§ 1301.13(c), (d). 130 Id. § 1301.52. 131 Id. § 1301.52(b). Congressional Research Service 13 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress Obligations of Registrants 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 al stocks of controlled control ed substances they have on hand, and maintain records of each controlled substance they manufacture, receive, sellsel , deliver, or otherwise dispose of.¹³⁰132 In addition, controlled substances in Schedules I and II may only be distributed pursuant to a written order.¹³¹133 Copies of each order form must be transmitted to DEA.¹³²134 Records of orders must be preserved for two years and made available available for government review upon request.¹³³

135 Registrants are also required to "“design and operate a system to identify suspicious orders"” and to notify DEA of any suspicious orders they detect.¹³⁴136 DEA regulations provide that "“[s]uspicious orders include orders of unusual size, orders deviating substantiallysubstantial y from a normal pattern, and orders of unusual frequency."¹³⁵”137 That list is not exhaustive, however—courts have suggested that orders may be orders may also be deemed suspicious if, for example, a pharmacy mostly sellssel s controlled substances rather than a more typical mix of controlled and noncontrolled medications, if many customers pay for controlledcontrol ed substances with cash, or if pharmacies purchase drugs at a price higher than insurance would reimburse.¹³⁶

Inspections

138 Inspections The CSA permits the DEA Administrator to inspect the establishment of any registrant or applicant for registration.¹³⁷139 DEA regulations express the intent of the agency "agency’s intent “to inspect all al 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 controlled substances "“as circumstances may require."¹³⁸”140 Absent the consent of the registrant or special circumstances such as an imminent danger to health or safety, a warrant is required for inspection.¹³⁹ "141 “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."¹⁴⁰”142 Issuance of a warrant requires probable cause.¹⁴¹143 The CSA defines probable cause as "“a valid public interest in the effective enforcement of this subchapter or regulations thereunder sufficient to justify"” the inspection at issue.¹⁴²

Security

The CSA's implementing regulations require all registrants to "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 See Masters Pharmas. Inc. v. DEA, 861 F.3d 206, 220 (D.C. Cir. 2017). 139 21 U.S.C. § 822(f). 140 21 C.F.R. §1316.13. 141 21 U.S.C. § 880(c). 142 Id. § 880(d)(1). 143 Id. 144 Id. T he CSA’s definition of probable cause is conceptually distinct from what is required under the Fourth Congressional Research Service 14 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."¹⁴³”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.¹⁴⁴ For example, nonpractitioners must store controlled substances in Schedules I and II in a safe, steel cabinet, or vault that meets certain specifications.¹⁴⁵ Nonpractitioners must further ensure that controlled substance storage areas are "accessible only to an absolute minimum number of specifically authorized employees."¹⁴⁶ Practitioners146 For example, practitioners147 subject to CSA registration must store controlled substances "“in a securely locked, substantially constructed cabinet."¹⁴⁷substantial y constructed cabinet.”148 In addition to those physical security requirements, practitioners subject to CSA registration may not "may not “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 registration denied, had a CSA registration revoked, or surrendered a CSA registration for cause.149 Registered non-practitioners must store control ed substances in Schedules I and II in a safe, steel cabinet, or vault that meets certain specifications.150 Non-practitioners must further ensure that controlled substance storage areas are “accessible only to an absolute minimum number of specifical y authorized employees.”151 Quotas cause.¹⁴⁸

Quotas

To prevent the production of excess amounts of controlled substances, which may be prone toincrease the likelihood of diversion, the CSA directs DEA to set aggregate production quotas for controlled control ed substances in Schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine.¹⁴⁹152 The DEA Administrator is also required to set individual quotas for each registered manufacturer seeking to produce such substances and to limit or reduce individual quotas as necessary to prevent oversupply.¹⁵⁰153 With respect to certain opioid medications, the Act further directs the DEA Administrator to estimate the amount of diversion of each opioid and reduce quotas to account for such diversion.¹⁵¹

154 Relatedly, the Controlled Substances Import and Export Act allowsal ows the importation of certain 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 States."¹⁵²

Prescriptions

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 he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.” 21 U.S.C. § 802(21). T he Act and its implementing regulations do not define the term “non -practitioner,” but it appears to include registrants not engaged in the practice of medicine, such as manufacturers and distribut ors. 148 21 C.F.R. §§ 1301.75(a), (b). 149 Id. § 1301.76(a). 150 21 C.F.R. § 1301.72(a). 151 Id. § 1301.72(d). 152 21 U.S.C. § 826(a); see also 21 C.F.R. § 1303.11. Ephedrine, pseudoephedrine, and phenylpropanolamine are List I chemicals that may be used 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 Congressional Research Service 15 link to page 20 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress Prescriptions 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.¹⁵³156 The Act does not mandate that Schedule V substances be distributed by prescription, but such substances may be dispensed only "“for a medical purpose."¹⁵⁴”157 As a practical matter, Schedule V substances are almost always dispensed pursuant to a prescription due to separate requirements under the FD&C Act or state law.¹⁵⁵

158 Enforcement and Penalties

DEA is the federal agency primarily responsible for enforcing the CSA'’s registration requirements.159s registration requirements.¹⁵⁶ If a registrant contravenes the Act's registration requirements, DEA may take formal or informal administrative action to enforce the registration requirements, including issuing warning letters, suspending or revoking an entity's ’s registration, and imposing fines.¹⁵⁷

160 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 application materials, been convicted of certain felonies, or "“committed such acts as would render his registration . . . inconsistent with the public interest."¹⁵⁸”161 Unless the DEA Administrator finds 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 to submit a corrective plan before denying, suspending, or revoking a registration.¹⁵⁹162 Imminent danger exists when, due to the failure of the registrant to comply with the registration requirements, "“there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will wil occur in the absence of an immediate suspension of the registration.”163 To il ustrate, those conditions may be satisfied when a practitioner prescribes substances, but does not establish specific export quotas. See id. § 953. 156 Id. §§ 829(a), (b). Substances in Schedule I may not be dispensed by prescription because they have no accepted medical use. 157 Id. § 829(c). 158 Cf., e.g., Ga. Code Ann. § 16-13-29.2 (permitting the State Board of Pharmacy to allow the sale of Schedule V controlled substances without a prescription); Fla. Stat. Ann. § 893.08 (permitting the sale of Schedule V controlled substances over-the-counter by a registered pharmacist, if a prescription is not required under the FD&C Act). 159 See 28 C.F.R. § 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 Abuse Prevention and Control Act of 1970). 160 See 21 U.S.C. §§ 822(f), 824(a), 842(c), 842(d). A person who must register under the CSA but fails to do so is subject to prosecution under the Act’s general trafficking provisions. See United States v. Blanton, 730 F.2d 1425, 1429-30 (11th Cir. 1984); see also infra “ T rafficking Provisions.” 161 21 U.S.C. § 824(a). 162 Id. §§ 824(c), (d). Enforcement actions based on imminent danger are subject to review by DEA, and a registrant may seek judicial review of the agency’s final decision under the Administrative Procedure Act. See, e.g., Volkman v. DEA, 567 F. 3d 215, 219 (6th Cir. 2006). 163 21 U.S.C. § 824(d)(2). Congress added 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 Drug Enforcement Act of 2016, Pub. L. No. 114-145, 130 Stat. 354 (2016). Those amendments made it more difficult for DEA to issue immediate suspensions: previously, the Act simply provided that “[t] he Attorney General [through the DEA Administrator] may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety.” 21 U.S.C. § 824(d) (2000). As amended, the Act limits DEA’s discretion by requiring a specific finding of “ imminent threat [of] death, serious bodily harm, or abuse of a controlled substance.” 21 U.S.C. § 824(d)(2); see also Scott Higham & Lenny Congressional Research Service 16 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress the registration"¹⁶⁰ Those conditions are satisfied, for example, when a practitioner prescribes controlled substances outside the usual course of professional practice without a legitimate medical purpose in violation of state and federal controlled substances laws.¹⁶¹

164 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 controlled substances without the necessary prescriptions—generallygeneral y does not constitute a criminal offense unless the violation is committed knowingly.¹⁶²165 However, in the event of a knowing violation DEA, through, DOJ, may bring criminal charges against both individual and corporate registrants. Potential penalties vary depending on the offense. For example, a first criminal violation of the registration requirements by an individual is punishable by a fine or up to a year in prison.¹⁶³166 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 diversion of opioids, itthe registrant may be punished by a fine of up to $500,000.¹⁶⁴

for each registration violation.167 Trafficking Provisions

In addition to the registration requirements outlined above, the CSA also contains provisions that define multiple offenses involving the production, distribution, and possession of controlledcontrol ed substances outside the legitimate confines of the registration system, that is, the Act'—what this report refers to as the Act’s trafficking provisions.¹⁶⁵168 Although the word "trafficking"“trafficking” may primarily call cal to mind the illegal il egal distribution of recreational drugs, the CSA'’s trafficking provisions in fact apply to a wide range of illicit of il icit activities involving either pharmaceutical or nonpharmaceutical controlled substances.¹⁶⁶

Prohibitions

The CSA's trafficking provisions make it illegal to "manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance," except as authorized under the Act.¹⁶⁷ They also make it unlawful "knowingly or intentionally to possess a controlled substance," unless the substance was obtained in a manner authorized by the CSA.¹⁶⁸ Penalties169 Prohibitions Key sections of the CSA’s trafficking provisions make the following activities il egal, unless otherwise authorized under the Act:  Manufacture of a controlled substance,170 which includes the synthesis of a controlled substance that is a chemical, the cultivation of a controlled substance that is a plant, or the processing or packaging of a controlled substance;171 Bernstein, The Drug Industry’s Trium ph over the DEA, WASH. POST, Oct. 15, 2017. 164 See Akhtar-Zaidi v. DEA, 841 F.3d 707, 710 (6th Cir. 2016). The court in Akhtar-Zaidi found that a physician violated federal and state law “ 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 relating t o the treatment of chronic pain,” and thus “ created a substantial likelihood that abuse of controlled substances would occur in the absence of an immediate suspension.” Id. at 710, 713. 165 21 U.S.C. § 842(c)(1). 166 Id. § 842(c)(2)(A). 167 Id. § 842(c)(2)(D). 168 See id. §§ 841-865. 169 See, e.g., id. §§ 841, 844 (criminalizing the manufacture, distribution, and possession of “a controlled substance,” except as authorized by the CSA). 170 Id. § 841(a)(1). 171 Id. §§ 802(15) (“‘manufacture’ means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container ”); 802(22) (“ ‘production’ includes the Congressional Research Service 17 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress  Distribution or dispensing of a controlled substance;172  Possession of a controlled substance with or without intent to distribute.173 Penalties for the foregoing offenses vary based on the type and amount of the controlled substance in question.¹⁶⁹174 Other sections of the CSA define more specific offenses, such as distributing controlled substances at truck stops or rest areas,¹⁷⁰175 at schools,¹⁷¹176 or to people under age 21;¹⁷²177 endangering human life while manufacturing a controlled substance;¹⁷³ selling drug paraphernalia;¹⁷⁴178 sel ing drug paraphernalia;179 and engaging in a "“continuing criminal enterprise"”—that is, an ongoing, large-scale drug dealing operation.¹⁷⁵ that involves at least five other people and provides the defendant with substantial income or resources.180 An attempt or conspiracy to commit any offense defined under the Act also constitutes a crime.¹⁷⁶

181 Enforcement and Penalties

DOJ enforces the CSA'’s trafficking provisions by bringing criminal charges against alleged violators.¹⁷⁷al eged violators.182 Notably, the CSA'’s registration system and its trafficking regime are not mutually mutual y exclusive, and participation in the registration system does not insulate registrants from the statute'statute’s trafficking penalties. In United States v. Moore, the Supreme Court rejected a claim that the CSA " “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.¹⁷⁸183 The Court in Moore held that physicians registered under the CSA can be prosecuted under the Act's ’s general drug trafficking provisions "“when their activities fall fal outside the usual course of professional practice."¹⁷⁹

”184 Numerous judicial opinions provide guidance on what sorts of conduct fall fal outside the usual course of professional practice. The defendant in Moore was a registered doctor who distributed 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 that respondent'’s conduct exceeded the bounds of '‘professional practice'"’” because, "“[i]n practical manufacture, planting, cultivation, growing, or harvesting of a controlled substance ”). 172 Id. § 841(a)(1). “Dispensing” refers to delivery of a controlled substance by a registered practitioner, including prescribing or administering a pharmaceutical controlled substance, while “ distribution” refers to other delivery of a controlled substance. Id. §§ 802(10), 802(11). 173 Id. §§ 841(a)(1) (criminalizing possess with intent to manufacture, distribute, or dispense, a controlled substance, except as aut horized under the Act); id. § 844(a) (making it unlawful “ knowingly or intentionally to possess a controlled substance,” unless the substance was obtained in a manner authorized by the CSA). 174 See, e.g., id. §§ 841(b). 175 Id. § 849. 176 Id. § 860. 177 Id. § 859. 178 Id. § 858. 179 Id. § 863. 180 Id. § 848. 181 Id. § 846. 182 T rafficking that involves smuggling may also implicate the Controlled Substances Import and Export Act, 21 U.S.C. §§ 951-971, and/or the Maritime Drug Law Enforcement Act, 46 U.S.C. §§ 70501 -70508. 183 423 U.S. 122, 133 (1975). 184 Id. at 124. Congressional Research Service 18 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress [i]n practical effect, he acted as a large-scale 'pusher' ‘pusher’—not as a physician."¹⁸⁰ Appellate”185 Appel ate courts have relied on Moore to uphold convictions of a pharmacist who signed thousands of prescriptions for sale through an online pharmacy,¹⁸¹pharmacy186 and a practitioner who "“freely distributed prescriptions for large amounts of controlled substances that are highly addictive, difficult to obtain, and sought after for nonmedical purposes.”187nonmedical purposes," including prescribing one patient more than 20,000 pills in a single year.¹⁸² But several courts have cautioned that a conviction under Moore 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 defendant "“acted with intent to distribute the drugs and with intent to distribute them outside the course of professional practice,"practice,” suggesting that specific intent must be established with respect to the defendant’to the nature of the defendant's failure to abide by professional norms.¹⁸³

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.¹⁸⁴189 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' company’s sale of the opioids oxycodone and fentanyl to pharmacies that illegally il egal y distributed the drugs.¹⁸⁵190 Similarly, in July 2019, a federal grand jury indicted defendants including two former executives at the pharmaceutical distributor Miami-Luken, Inc., among others, for conspiracy to violate the CSA's ’s trafficking provisions.¹⁸⁶

Violations 191 Violations of the CSA'’s trafficking provisions are criminal offenses that may give rise to large fines and significant jailprison 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.¹⁸⁷192 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 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, 454 F.3d 1001, 1008 (9th Cir. 2006) (emphasis in original); see also United States v. Armstrong, 550 F.3d 382, 401 (5th Cir. 2008) (explaining that “ the m ens rea of a § 841 offense is encompassed in the second and third element of the crime—whether the practitioner intentionally dispensed co ntrolled substances without a legitimate medical purpose or outside the scope of professional practice,” and distinguishing “ a § 841 prosecution from a mere civil malpractice suit where a plaintiff may prevail regardless 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 jury instructions “ nearly identical” to those upheld in Feingold and holding that “ the jury, on the instructions given, found that [the defendant] knowingly acted not for a legitimate medical purpose or not within the usual course of professional practice”). 189 See, e.g., Moore, 423 U.S. 122; Press Release, DEA, Multiple Cases Lead to Arrests of Five Doctors, One Pharmacist, One Nurse Practitioner and T hree Others (Oct. 11, 2018), https://www.dea.gov/press-releases/2018/10/11/multiple-cases-lead-arrests-five-doctors-one-pharmacist -one-nurse; Press Release, DEA, DEA Large-scale Operation T argets 26 Pharmacies In T hree States In Attack Against Illicit Opioid Abuse And T rafficking (Dec. 5, 2017), https://www.dea.gov/press-releases/2017/12/05/dea-large-scale-operation-targets-26-pharmacies-three-states-attack. 190 See Press Release, DOJ, Manhattan U.S. Attorney And DEA Announce Charges Against Rochester Drug Co-Operative And T wo Executives For Unlawfully Distributing Controlled Substances (Apr. 23, 2019), https://www.justice.gov/usao-sdny/pr/manhattan-us-attorney-and-dea-announce-charges-against -rochester-drug-co-operative-and; see also CRS Legal Sidebar LSB10307, Corporate Drug Trafficking Liability—a New Legal Front in the Opioid Crisis, 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). Congressional Research Service 19 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress $10 mil ion for an individual or a fine of up to $50 mil ion for an organization.193for an organization.¹⁸⁸ Penalties increase for second or subsequent offenses, or if death or serious bodily injury results from the use of the controlled substance.¹⁸⁹194 Compared with the CSA'’s registration provisions, prosecution under the Act's the Act’s trafficking provisions generally entailsgeneral y entail greater potential liability—particularly for individual defendants—but also entails a more exacting burden of proof.¹⁹⁰

require prosecutors to show that a violation was intentional.195 The CSA is not the only means to target misconduct related to the distribution of pharmaceutical and nonpharmaceutical controlled substances. Rather, such conduct can give rise to liability under numerous other provisions of federal and state law. For example, drug companies may face administrative sanctions or criminal charges under the FD&C Act.¹⁹¹196 Companies and criminal organizations mayindividuals may also be subject to federal criminal charges under the Racketeer Influenced and Corrupt Organizations Act.¹⁹²Act197 or the Federal Anti-Kickback Statute.198 Those statutes notably formed part of the basis for the significant settlement between DOJ and opioid manufacturer Purdue Pharma in 2020.199 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.¹⁹³

opioids.200 Legal Considerations for the 116th117th 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; and the ability of researchers to conduct clinical research involving Schedule I controlled substances.

; and the response to the COVID-19 pandemic. Opioid Crisis One Opioid Crisis

One of the most salient current issuesissue in the realm of controlledcontrol ed substance regulation is the opioid epidemic. Opioids are drugs derived from the opium poppy or emulating the effects of opium-derived drugs.¹⁹⁴ 193 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. See 21 U.S.C. § 842. By contrast, a violation of the CSA’s trafficking provision s must be committed “ knowingly or intentionally,” with corporations subject to liability “based on the ‘knowledge and intent’ of their employees.” United States v. Philip Morris USA Inc., 566 F.3d 1095, 1118 (D.C. Cir. 2009); see also 21 U.S.C. § 841. 196 See, e.g., id. § 333; see also CRS Report R43609, Enforcement of the Food, Drug, and Cosmetic Act: Select Legal Issues, by Jennifer A. Staman. 197 See, e.g., Press Release, DOJ, Founder and Owner of Pharmaceutical Company Insys Arrested and Charged with Racketeering (Oct. 26, 2017); Gabrielle Emmanuel and Katie T homas, Opioid Com pany Executives Convicted of Racketeering, N.Y. T IMES, May 3, 2019, at B1. 198 See, e.g., Press Release, DOJ, Justice Department Announces Global Resolution of Criminal and Civil Investigations with Opioid Manufacturer Purdue Pharma and Civil Settlement with Members of the Sackler Family (Oct. 21, 2020). 199 Purdue Pharma LP plead 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. Congressional Research Service 20 The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress drugs.201 Some opioids have legitimate medical purposes, primarily related to pain management, while others have no recognized medical use.¹⁹⁵202 Both pharmaceutical opioids— (such as oxycodone, codeine, and morphine—) and nonpharmaceutical opioids— (such as heroin—) may pose a risk of abuse and dependence and may be dangerous or even deadly in excessive doses.¹⁹⁶203 The CDC reports that overdoses onof prescription and nonprescription opioids claimed a record 47,600over 50,000 lives in 2019.204 CDC researchers further estimatein 2017.¹⁹⁷ The CDC further estimates that the misuse of prescription opioids alone costscost the United States $78.5 billion per year.¹⁹⁸

bil ion in 2013.205 In recent years, the opioid crisis has prompted various legislative proposals aiming to prevent the illicit il icit 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, Congress enacted the Comprehensive Addiction and Recovery Act of 2016 (CARA)¹⁹⁹206 and the 21st Century Cures Act (Cures Act).²⁰⁰207 CARA authorized grants to address the opioid crisis in areas including abuse prevention and education, law enforcement, and treatment, while the Cures Act, among other things, provided additional funding to states combating opioid addiction.²⁰¹208 In 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 opioid crisis through far-ranging amendments to the CSA, the FD&C Act, and other statutes.²⁰² 209 Key amendments to the CSA under the SUPPORT Act included provisions expanding access to medication-assisted treatment for opioid addiction,²⁰³210 specifying the factors for determining whether a controlled substance analogue is intended for human consumption,²⁰⁴211 revising the factors DEA considers when establishing opioid production quotas,²⁰⁵212 and codifying the definition of "“suspicious order"” and outlining the CSA'’s suspicious order reporting requirements.²⁰⁶

Notwithstanding the flurry of recent legal changes, many recent legislative proposals seek to further address the opioid crisis by 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 Report R45449, The SUPPORT for Patients and Communities Act (P.L.115-271): Medicare Provisions, coordinated by Suzanne M. Kirchhoff. 209 Pub. L. No. 115-271, 132 Stat. 3894 (2018); see also CRS Report R45449, The SUPPORT for Patients and Com m unities Act (P.L.115-271): Medicare Provisions, coordinated by Suzanne M. Kirchhoff; CRS Report R45423, Public Health and Other Related Provisions in P.L 115 -271, the SUPPORT for Patients and Com m unities Act, coordinated by Elayne J. Heisler and Johnathan H. Duff ; CRS Report R45405, The SUPPORT for Patients and Com m unities Act (P.L. 115-271): Food and Drug Adm inistration and Controlled Substan ce Provisions, coordinated by Agata Bodie. 210 Pub. L. No. 115-271, §§ 3201-04. 211 Id. § 3241. 212 Id. § 3282. 213 Id. §§ 3291-92. Congressional Research Service 21 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.214amending the CSA.²⁰⁷ For example, the DEA Enforcement Authority Act of 2019²⁰⁸ would revise the standard for "imminent danger" required to support an immediate suspension of DEA registration. Specifically, the bill would lower2019215 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, requiring "al owing suspension upon a finding of “probable cause that death, serious bodily harm, or abuse of a controlled substance will wil occur in the absence of an immediate suspension of the registration,"” rather than the current statutory requirement that "of “a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will wil occur in the absence of an immediate suspension of the registration."²⁰⁹”216 In addition, the John S. McCain Opioid Addiction Prevention Act²¹⁰ would, as part of the CSA's registration regime, requireAct217 would have required medical practitioners applying for new or renewed CSA registration to certify that they will wil not prescribe more than a seven-day supply of opioids for the treatment of acute pain.²¹¹218 The LABEL Opioids Act219 would have amendedOpioids Act²¹² would amend the CSA to require that opioids in Schedules III through V bear labels warning that they can cause dependence, addiction, and overdose. Failure to comply with the labeling requirements would violatehave violated the CSA'’s registration requirements.²¹³

Some proposals target specific opioids, especially fentanyl. For instance, the Ending the Fentanyl Crisis Act of 2019²¹⁴ would amend the CSA to reduce the amounts of fentanyl required to constitute a trafficking offense. The Comprehensive Fentanyl Control Act,²¹⁵ introduced in the 115th Congress, would likewise have reduced the amount of fentanyl triggering criminal liability. That bill would have 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.²¹⁶227 The Screening All Al Fentanyl-Enhanced Mail Act of 2019²¹⁷ seeks2019228 sought to require screening of all al inbound international mail and express cargo from high-risk countries to detect and prevent the importation of illicitil icit fentanyl and other synthetic opioids. FinallyFinal y, the Blocking Deadly Fentanyl Imports Act²¹⁸ would aimAct229 aimed to gather information about the illicit production of illicitil 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 currently beforethat garnered significant attention in the 116th Congress is the proliferation of synthetic drugs, especiallyespecial y synthetic opioids. SyntheticIn contrast to drugs derived from natural materials such as plants, synthetic drugs are drugs that are chemicallychemical y produced in a laboratory; they may have a chemical structure identical to or different from that of a natural drug.²¹⁹ Synthetic drugs are often intended to mimic or enhance the effects of natural drugs, 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.²²⁰

232 One particular concern in this area relates to synthetic opioids, including fentanyl analogues and other fentanyl-like substances. other fentanyl-like substances. Fentanyl is a powerful opioid that has legitimate medical uses including pain management for cancer patients.²²¹ But, due to its potency, it also poses a particularly high risk of abuse, dependency, and overdose.²²² Prescription fentanyl is a Schedule II controlled substance; multiple multiple nonpharmaceutical substances related to fentanyl are controlled in Schedule I.²²³ 233 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 may have similar effects to fentanyl or pose other dangers if consumed but that are not included in the CSA's schedules.²²⁴

Even if not individually scheduled on a temporary or permanent basis, fentanyl-related substances may still be subject to DEA control as controlled substance analogues.²²⁸ However, to secure a conviction for an offense involving an analogue controlled substance, DOJ must, among other elements, prove beyond a reasonable doubt 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.²²⁹ Thus, DOJ has stated that analogue controlled substance prosecutions can be burdensome because they raise "complex chemical and scientific issues," and has argued that permanent scheduling of fentanyl analogues will reduce uncertainty and aid enforcement.²³⁰

A key challengehave 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 all 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.²³⁵ Defining242 On one hand, defining covered substances based on chemical structure may be overinclusive because the definition may include inactive substances, potentially allowingpotential y al owing for prosecution of individuals who possess substances that pose no threat to public health and safety.²³⁶243 On the other hand, such a definition may also be underinclusive because it excludes opioids that are not chemicallychemical y related to fentanyl or that are made using different modifications to fentanyl'’s chemical structure.²³⁷ 244 Alternatively, defining covered opioids based on their effects rather than their chemical structure could impose a heavy burden on prosecutors, similar to the burden theywould 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 “essentially inactive.” See DEA, Correction of Code of Federal Regulations: Removal of T emporary Listing of Benzylfentanyl and T henylfentanyl as Controlled Substances, 75 Fed. Reg. 37,300, 37,300 (June 29, 2010). 243 See Letter from A New PAT H, et al. to Sens. Graham and Feinstein (July 1, 2019), https://www.hrw.org/news/2019/07/03/coalition -opposes-s1622-stopping-overdoses-fentanyl-analogues-act-sofa. 244 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). 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 24 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 collateral consequences arising from the federal prohibition of marijuana. Other federal laws impose legal consequences based on criminal activity, including violations of the CSA. For example, even if authorized under state law, cannabis businesses may be unable to access banking services due to federal anti-money laundering laws,266 and those businesses may be ineligible for certain federal tax deductions.267 The involvement of income from a cannabis-related business may also prevent a bankruptcy court from approving a bankruptcy plan.268 For individuals, participation in the cannabis industry may have adverse immigration consequences.269 Drug 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 -fda-commissioner-scott-gottlieb-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 remove cannabis and cannabis resin from Schedule IV. See Press Release, United Nations Com m ission on Narcotic Drugs, CND Votes on Recom m endations for Cannabis and Cannabis-related 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.controlled substance charges.²³⁸

Marijuana Policy Gap

Research Access