The 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 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 CSA also applies
to controlled substance analogues that are intended to mimic the effects of controlled substances and to certain precursor
chemicals 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 pose 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.
Many substances regulated 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 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 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 take various steps 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 Act’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 to amend the CSA in various ways. For example, the 116th Congress considered multiple proposals aimed at
addressing the opioid crisis, including the John S. McCain Opioid Addiction Prevention Act (H.R. 1614, S. 724), which
would have limited practitioners’ ability to prescribe opioids; the LABEL Opioids Act (H.R. 2732, S. 1449), which would
have required prescription opioids to bear certain warning labels; and the Ending the Fentanyl Crisis Act of 2019 (S. 1724),
which would have increased criminal liability for illicit trafficking in the powerful opioid fentanyl. The 116th Congress also
enacted the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act (P.L. 116-114),
which placed a broad class of fentanyl analogues in Schedule I on a temporary basis , and considered other measures
specifically seeking to address the proliferation of synthetic drugs that mimic the effects of fentanyl. In addition, multiple
recent proposals sought to address 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.
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rescription drugs play a vital role in American public health. The Centers for Disease
Control and Prevention (CDC) estimates that during 2015 and 2016 over 45% of
Americans had used one or more prescription drugs in the last 30 days.1 But unfettered
P access to drugs may pose serious public health risks. The CDC reports that in 2018 over
67,000 Americans died of overdoses of prescription and nonprescription drugs.2 The
Controlled Substances Act3 (CSA or the Act) seeks to balance those competing 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.5 By establishing rules for the
proper handling of controlled substances6 and imposing penalties for any il icit production,
distribution, or possession of such substances,7 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
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 117th 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.9 It then outlines the five main categories of substances
subject to the Act—known as schedules—and discusses how substances are added to the
schedules.10 The report next outlines the CSA’s registration requirements, which govern the
activities of individuals and entities that register with the government to receive authorization to
handle pharmaceutical controlled substances,11 before summarizing the CSA’s criminal
trafficking provisions, which apply to controlled-substance-related activities that are not
authorized under the Act.12 Final y, 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, the legal limits on medical use of certain controlled substances, and the
effects of the COVID-19 pandemic on control ed substance regulation.13
Background and Scope of the CSA
Congress has regulated drugs in some capacity since the 19th century. Federal drug regulation
began with tariffs, import and export controls, and purity and labeling requirements applicable to

1 See Crescent B. Martin, et al., Prescription Drug Use in the United States, 2015–2016, NCHS DATA BRIEF No. 334
(May 2019).
2 See Holly Hedegaard, et al., Drug Overdose Deaths in the United States, 1999–2018, NCHS DATA BRIEF No. 356
(Jan. 2020).
3 21 U.S.C. §§ 801-904. Unless otherwise indicated, this report uses United States Code citations for statutory material.
4 See id. §§ 801(1), (2).
5 See id. §§ 802(6), 811.
6 See id. §§ 821-832.
7 See id. §§ 841-865.
8 See id. §§ 801(1), (2).
9 See infra “Background and Scope of the CSA” and “ Other Regulatory Schemes.”
10 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.”
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narcotic drugs such as opium and coca leaves and their derivatives.14 With the passage of the
Harrison Narcotics Tax Act of 1914, Congress began in earnest to regulate the domestic trade in
narcotic drugs.15 The Harrison Act imposed federal oversight of the legal trade in narcotic drugs
and imposed criminal penalties for il icit trafficking in narcotics.16 Over the course of the 20th
century, the list of drugs subject to federal control expanded beyond narcotic drugs to include
marijuana, depressants, stimulants, and hal ucinogens.17
In 1970, Congress revamped federal drug regulation by enacting the Comprehensive Drug Abuse
Prevention and Control Act.18 That act repealed nearly al existing federal substance control laws
and, for the first time, imposed a unified framework of federal controlled substance regulation.19
Title II of the Comprehensive Drug Abuse Prevention and Control Act is known as the Controlled
Substances Act.20
The CSA regulates certain drugs21—whether medical or recreational, legal y or il icitly
distributed—that are found to pose a risk of abuse and dependence.22 In enacting the CSA,
Congress recognized two competing interests related to drug regulation. 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 On the other hand, “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 Accordingly, the
Act simultaneously aims to protect public health from the dangers of controlled substances while
also ensuring access to controlled substances for legitimate 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.25 Trafficking provisions establish penalties for the production,
distribution, and possession of controlled substances outside the legitimate scope of the
registration system.26

14 T homas M. Quinn & Gerald T . 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.
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The CSA does not apply to al drugs. As discussed below, substances must be specifical y
identified for control (either individual y or as a class) to fal within the scope of the Act.27 For
medical drugs, the CSA primarily applies to prescription drugs, not drugs available over the
counter.28 Moreover, the statute does not apply to al prescription drugs, but rather to a subset of
those drugs deemed to warrant additional controls.29 As for nonpharmaceutical drugs, wel -known
recreational drugs such as marijuana, cocaine,30 heroin, and lysergic acid diethylamide (LSD) are
al controlled substances, as are numerous lesser-known substances, some of which are identified
only by their chemical formulas.31 Some recreational drugs are not classified as federal y
controlled substances.32 Alcohol and tobacco, which might otherwise qualify as drugs potential y
warranting control under the CSA, are explicitly excluded from the scope of the Act,33 as is hemp
that meets certain statutory requirements.34 Final y, it is possible for legitimate researchers and
il icit drug manufacturers to formulate new drugs not listed in any of the Act’s schedules. Even if
those drugs are similar to existing controlled substances, they may fal outside the scope of the
CSA unless they are classified as controlled substances.35
Other Regulatory Schemes
Many drugs classified as controlled substances subject to the CSA are also subject to other legal
regimes. For example, al pharmaceutical drugs, including those subject to the Act, are subject to
the Federal Food, Drug, and Cosmetic Act (FD&C Act).36 The U.S. Food and Drug
Administration (FDA) is the agency primarily responsible for enforcing the FD&C Act which,
among other things, prohibits the “introduction or delivery for introduction into interstate
commerce of any . . . drug . . . that is adulterated or misbranded.”37 The FD&C Act defines
misbranding broadly: a drug is considered misbranded if, among other things, its labeling,

27 Id. § 811.
28 Id. § 829; see also infra “Prescriptions.”
29 T he 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).
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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.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.42 The FD&C Act, by contrast, is a consumer protection statute that
seeks to protect consumers from obtaining unsafe or ineffective drugs (and other public health
products) through commercial channels.43 Any person or organization that produces, distributes,
or otherwise works with prescription drugs that are also controlled substances must comply with
the requirements of both the CSA and the FD&C Act.
With respect to both pharmaceutical and nonpharmaceutical drugs, many drugs subject to the
CSA are also subject to state controlled substance laws.44 State substance control laws often
mirror federal law and are relatively uniform across jurisdictions because almost al states have
adopted a version of a model statute cal ed the Uniform Controlled Substances Act (UCSA).45
However, states are free to modify the UCSA, and have done so to varying extents.46 Moreover,
the model statute does not specify sentences for violations, so penalties for state controlled
substance offenses vary widely.47
There is not a complete overlap between drugs subject to federal and state control for several
reasons. First, states may elect to impose controls on substances that are not subject to the CSA.48
For example, some states have controlled the fentanyl analogues benzylfentanyl and
thenylfentanyl, but those substances are not currently scheduled under the CSA.49 Second, states

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
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may wish to adopt federal scheduling decisions at the state level but lag behind federal regulators
due to the need for a separate state scheduling process.50 Third, states may decide not to impose
state controls on substances subject to the CSA, or they may choose to impose modified versions
of federal controls at the state level.51
Crucial y, however, the states cannot alter federal law, and when state and federal law conflict, the
federal law controls.52 Thus, when states “legalize” or “decriminalize” a federal 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.53 Any federal controls remain in effect and
potential y enforceable in those states.54
Classification of Controlled Substances
The heart of the CSA is its system for classifying controlled substances, as nearly al the
obligations and penalties that the Act establishes flow from the classification system.55 Drugs
become subject to the CSA by being placed in one of five lists, referred to as “schedules.”56 Both
the Administrator of the Drug Enforcement Administration (DEA)—an arm of the Department of
Justice (DOJ)—and Congress can place a substance in a schedule, move a controlled substance to
a different schedule, or remove a controlled substance from a schedule.57 As discussed below,
scheduling decisions by Congress and DEA follow different procedures.58
Overview of Schedules
The CSA establishes five categories of controlled substances, referred to as Schedules I through
V.59 The schedule on which a controlled substance is placed determines the level of restriction
imposed on its production, distribution, and possession, as wel as the penalties applicable to any
improper handling of the substance.60 As Figure 1 describes, when DEA places substances under

federal law and Arizona law); McCoy v. United States, 707 F.3d 184 (2d Cir. 2013) (same with respect to Connecticut
law). 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).
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The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress

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

Notes:
1 21 U.S.C. § 812(b)(1).
2 The CSA general y uses the word “marihuana” to refer to the cannabis plant and its derivatives. This report
uses the more widely accepted spel ing, “marijuana,” unless quoting other sources.
3 For the ful list of substances in Schedule I, see 21 C.F.R. § 1308.11.
4 21 U.S.C. § 812(b)(2).
5 The CSA distinguishes between prescription fentanyl and il icit fentanyl. Prescription fentanyl and several
related medications are in Schedule II. Numerous nonprescription fentanyl analogues are in Schedule I.
6 For the ful list of substances in Schedule II, see 21 C.F.R. § 1308.12.
7 21 U.S.C. § 812(b)(3).
8 For the ful list of substances in Schedule III, see 21 C.F.R. § 1308.13.
9 21 U.S.C. § 812(b)(4).
10 For the 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 ful list of substances in Schedule V, see 21 C.F.R. § 1308.15.
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A lower schedule number corresponds to greater restrictions, so controlled substances in Schedule
I are subject to the most stringent controls, while substances in Schedule V are subject to the least
stringent.61 Notably, because substances in Schedule I have no accepted medical use, it is only
legal to produce, dispense, and possess those substances in the context of federal y approved
scientific studies.62
Analogues and Listed Chemicals
In addition to the controlled substances listed in Schedules I through V, the CSA also regulates
(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 specifical y scheduled under the Act, but that has (1) a chemical structure substantial y
similar to that of a controlled substance in Schedule I or II, or (2) an actual or intended effect that
is “substantial y similar to or greater than the stimulant, depressant, or hal ucinogenic effect on
the central nervous system of a controlled substance in schedule I or II.”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 produce controlled substances.65 They may be placed on
one of two lists:

61 See John Doe, Inc. v. DEA, 484 F.3d 561, 563 (D.C. Cir. 2007) (“ Schedule I is the most stringently controlled, and
schedule V the least .”).
62 See 21 U.S.C. § 823(f); see also Gonzales v. Raich, 545 U.S. 1, 14 (2004). Perhaps counterintuitively, marijuana and
marijuana extract are in Schedule I, see 21 C.F.R. §§ 1308.11(23), 1308.11(58), but FDA-approved drugs containing
the marijuana extract cannabidiol (CBD) are in Schedule V, see id. § 1308.15(f). As of July 2019, FDA has approved
one drug containing CBD, a seizure medication called Epidiolex. See Press Release, FDA, FDA Approves First Drug
Comprised of an Active Ingredient Derived from Marijuana to T reat Rare, Severe Forms of Epilepsy (June 26, 2018),
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient -derived-
marijuana-treat -rare-severe-forms; see also CRS In Focus IF11250, FDA Regulation of Cannabidiol (CBD) Consum er
Products, by Agata Bodie and Renée Johnson.
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).
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 List I Chemicals—designated chemicals that, in addition to legitimate uses, are
used in manufacturing a controlled substance in violation of the CSA and are
important to the manufacture of a controlled substance.66
 List II Chemicals—designated chemicals that, in addition to legitimate uses, are
used in manufacturing a controlled substance in violation of the CSA.67
List I chemicals include substances such as ephedrine, white phosphorous, and iodine, which are
used to produce methamphetamine, as wel as chemicals used to manufacture LSD, MDMA (also
known as “ecstasy” or “molly”), and other drugs.68 List II chemicals include, among others,
solvents such as acetone, hydrochloric acid, and sulfuric acid.69
Listed chemicals are subject to some controls similar to those that apply to controlled
substances.70 In addition, entities that sel listed chemicals must record the transactions, report
them to regulators, and comply with statutory limits on sales to a single purchaser.71
There are a number of differences between how controlled substance analogues and listed
chemicals are regulated. In addition, listed chemicals include only specific substances identified
for control under the CSA by statute or rulemaking.72 By contrast, controlled substance analogues
need not be individual y scheduled; they need only satisfy the statutory criteria.73
Scheduling Procedures
Substances may be added to or removed from a schedule or moved to a different schedule
through agency action or by legislation.74 As described below, the procedures for modifying a
substance’s scheduling differ depending on whether Congress or DEA makes the change.
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 poses 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

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).
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(commonly referred to as synthetic marijuana) to Schedule I.75 More recently, in February 2020,
Congress enacted the Temporary Reauthorization and Study of the Emergency Scheduling of
Fentanyl Analogues Act, which placed a broad class of fentanyl analogues in Schedule I on a
temporary basis.76
Administrative Scheduling
DEA makes scheduling decisions through a complex process requiring participation by other
agencies and the public.77 DEA may undertake administrative scheduling on its own initiative, at
the request of the U.S. Department of Health and Human Services (HHS), or “on the petition of
any interested party.”78 With regard to the last route for initiating administrative scheduling, the
DEA Administrator may deny a petition to begin scheduling proceedings based on a finding that
“the grounds upon which the petitioner relies are not sufficient to justify the initiation of
proceedings.”79 Denial of a petition to initiate scheduling proceedings is subject to judicial
review, but courts wil overturn a denial only if it is arbitrary and capricious.80
Before initiating rulemaking proceedings, DEA must request a scientific and medical evaluation
of the substance at issue from the Secretary of HHS.81 The HHS Secretary has delegated the
authority to prepare the scientific and medical evaluation to FDA.82 In preparing the evaluation,
FDA considers a number of factors, including the substance’s potential for abuse and dependence,
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.83 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.84 FDA’s scientific and medical findings are binding on DEA.85
Furthermore, if FDA recommends against controlling the substance, DEA may not schedule it.86

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

87 Id. Like FDA, the DEA Administrator is required to consider all the factors in 21 U.S.C. §§ 811(c)(1)-(8) in making
this determination.
88 Id. § 812(b).
89 5 U.S.C. § 500, et seq.
90 21 U.S.C. § 811(a); see also T ouby v. United States, 500 U.S. 160, 162-63 (1991).
91 See id. § 877.
92 See All. for Cannabis T herapeutics 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).
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Pursuant to amendments in the Synthetic Drug Abuse Prevention Act of 2012,101 a substance may
be temporarily scheduled for up to two years; if permanent scheduling proceedings are pending,
the DEA Administrator may extend the temporary scheduling period for up to one additional
year.102 A temporary scheduling order is vacated once permanent scheduling proceedings are
completed with respect to the substance at issue.103 The CSA provides that emergency scheduling
orders are not subject to judicial review.104
DEA has recently used its emergency scheduling power to temporarily control certain analogues
to the opioid fentanyl105 and several synthetic cannabinoids.106
International Treaty Obligations
The United States is a party to the Single Convention on Narcotic Drugs of 1961, whic h was
designed to establish controls on the international and domestic traffic in narcotics, coca leaf,
cocaine, and marijuana.107 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” 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 hal 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.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.”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.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.
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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.113 The goal of the
regulatory scheme is to create a “closed system” of distribution in which only authorized handlers
may distribute controlled substances.114 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,115 are referred to as registrants.116 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.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.118 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.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.120 Significantly, the CSA exempts from registration individual consumers of control ed
substances, such as patients and their family members, whom the Act 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).
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users.”121 Ultimate users and other entities exempt from the CSA’s registration provisions can
stil violate the Act’s criminal trafficking provisions if they engage in unauthorized activities.122
Manufacturers and distributors of controlled substances, such as pharmaceutical companies, must
register with DEA annual y.123 By contrast, entities that dispense controlled substances, such as
hospitals, pharmacies, and individual medical practitioners and pharmacists, may obtain
registrations lasting between one and three years.124 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.125 Special registration is required for
certain activities, including operating an opioid treatment program such as a methadone clinic.126
The CSA directs the DEA Administrator to issue a registration if it would be consistent with the
public interest, and the Act outlines the criteria the DEA Administrator must consider when
evaluating the public interest.127 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 general y serve to
help DEA determine whether the applicant has demonstrated the capacity to maintain effective
controls against diversion and comply with applicable laws.128
The registration of an individual or organization expires at the end of the registration period
unless it is renewed.129 Registration also ends when the registrant dies, ceases legal existence, or
discontinues business or professional practice.130 A registration cannot be transferred to someone
else without the express, written consent of the DEA Administrator.131

121 21 U.S.C. § 822(c)(3). See also id. § 802(25) (defining “ultimate user” as a “ person who has lawfully obtained, and
who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal
owned by him or by a member of his household”). DEA has explained that ultimate users need not register because the
controlled substances in their possession “ are no longer part of the closed system of distribution and are no longer
subject to DEA’s system of corresponding accountability.” DEA, Definition and Registration of Reverse Distributors,
68 Fed. Reg. 41,222, 41,226 (proposed July 11, 2003). Some other exemptions are specified by statute, see 21 U.S.C.
§§ 822(c)(1), (2); or by regulation, see 21 C.F.R. §§ 1301.22-24.
122 Cf. United States v. Mancuso, 718 F.3d 780, 798 (9th Cir. 2013) (rejecting an argument that defendant was “merely
‘an ultimate user’” of cocaine because he shared the drug with others, and sharing drugs constitutes “distribution” for
purposes of the CSA’s 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).
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Obligations of Registrants
Recordkeeping and Reporting
The CSA and its implementing regulations impose multiple recordkeeping and reporting
requirements on registrants. Registrants must undertake a biennial inventory of al stocks of
control ed substances they have on hand, and maintain records of each controlled substance they
manufacture, receive, sel , deliver, or otherwise dispose of.132 In addition, controlled substances in
Schedules I and II may only be distributed pursuant to a written order.133 Copies of each order
form must be transmitted to DEA.134 Records of orders must be preserved for two years and made
available for government review upon request.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.136 DEA regulations provide that “[s]uspicious
orders include orders of unusual size, orders deviating substantial y from a normal pattern, and
orders of unusual frequency.”137 That list is not exhaustive, however—courts have suggested that
orders may be suspicious if, for example, a pharmacy mostly sel s controlled substances rather
than a more typical mix of controlled and noncontrolled medications, if many customers pay for
control ed substances with cash, or if pharmacies purchase drugs at a price higher than insurance
would reimburse.138
Inspections
The CSA permits the DEA Administrator to inspect the establishment of any registrant or
applicant for registration.139 DEA regulations express the agency’s intent “to inspect 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.”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.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.”142 Issuance of a
warrant requires probable cause.143 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.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
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Security
The CSA’s implementing regulations require al registrants to “provide effective controls and
procedures to guard against theft and diversion of controlled substances.”145 The regulations
establish specific physical security requirements, which vary depending on the type of registrant
and the classification of the controlled substance at issue.146 For example, practitioners147 subject
to CSA registration must store controlled substances “in a securely locked, substantial y
constructed cabinet.”148 In addition to those physical security requirements, practitioners may not
“employ, as an agent or employee who has access to controlled substances” any person who has
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
To prevent the production of excess amounts of controlled substances, which may increase the
likelihood of diversion, the CSA directs DEA to set aggregate production quotas for control ed
substances in Schedules I and II and for ephedrine, pseudoephedrine, and
phenylpropanolamine.152 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.153 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.154
Relatedly, the Controlled Substances Import and Export Act al 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.”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
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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.156 The Act does
not mandate that Schedule V substances be distributed by prescription, but such substances may
be dispensed only “for a medical purpose.”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.158
Enforcement and Penalties
DEA is the federal agency primarily responsible for enforcing the CSA’s registration
requirements.159 DEA may take formal or informal administrative action to enforce the
registration requirements, including issuing warning letters, suspending or revoking an entity’s
registration, and imposing fines.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.”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.162 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 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
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controlled substances outside the usual course of professional practice without a legitimate
medical purpose in violation of state and federal controlled substances laws.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—general y does not constitute a
criminal offense unless the violation is committed knowingly.165 However, in the event of a
knowing violation, DOJ may bring criminal charges against both individual and corporate
registrants. Potential penalties vary depending on the offense. For example, a first criminal
violation of the registration requirements by an individual is punishable by a fine or up to a year
in prison.166 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, the registrant may be punished by a fine of up to $500,000 for each
registration violation.167
Trafficking Provisions
In addition to the registration requirements outlined above, the CSA contains provisions that
define offenses involving the production, distribution, and possession of control ed substances
outside the legitimate confines of the registration system—what this report refers to as the Act’s
trafficking provisions.168 Although the word “trafficking” may primarily cal to mind the il egal
distribution of recreational drugs, the CSA’s trafficking provisions in fact apply to a wide range
of il icit activities involving either pharmaceutical or nonpharmaceutical controlled substances.169
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
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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.174 Other sections of the CSA define more specific offenses, such as
distributing controlled substances at truck stops or rest areas,175 at schools,176 or to people under
age 21;177 endangering human life while manufacturing a controlled substance;178 sel ing drug
paraphernalia;179 and engaging in a “continuing criminal enterprise”—that is, an ongoing drug
dealing operation that involves at least five other people and provides the defendant with
substantial income or resources.180 An attempt or conspiracy to commit any offense defined under
the Act also constitutes a crime.181
Enforcement and Penalties
DOJ enforces the CSA’s trafficking provisions by bringing criminal charges against al eged
violators.182 Notably, the CSA’s registration system and its trafficking regime are not mutual y
exclusive, and participation in the registration system does not insulate registrants from the
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.183 The
Court in Moore held that physicians registered under the CSA can be prosecuted under the Act’s
general drug trafficking provisions “when their activities fal outside the usual course of
professional practice.”184
Numerous judicial opinions provide guidance on what sorts of conduct 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.
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effect, he acted as a large-scale ‘pusher’—not as a physician.”185 Appel ate courts have relied on
Moore to uphold convictions of a pharmacist who signed thousands of prescriptions for sale
through an online pharmacy186 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.”187 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,” suggesting that specific intent must be established with respect
to the defendant’s failure to abide by professional norms.188
For decades, DOJ has brought criminal trafficking charges against doctors and pharmacists who
dispensed pharmaceutical controlled substances outside the usual course of professional
practice.189 In April 2019, DOJ for the first time brought criminal trafficking charges against a
pharmaceutical company—Rochester Drug Cooperative—and two of its executives based on the
company’s sale of the opioids oxycodone and fentanyl to pharmacies that il egal y distributed the
drugs.190 Similarly, in July 2019, a federal grand jury indicted two former executives at the
pharmaceutical distributor Miami-Luken, Inc, among others, for conspiracy to violate the CSA’s
trafficking provisions.191
Violations of the CSA’s trafficking provisions are criminal offenses that may give rise to large
fines and significant prison time. Penalties vary according to the offense and may further vary
based on the type and amount of the controlled substance at issue. Unauthorized simple
possession of a controlled substance may prompt a minimum fine of $1,000 and a term of up to a
year in prison.192 Distribution of large quantities of certain drugs—including specific Schedule I
controlled substances such as heroin and LSD and specific Schedule II controlled substances such
as cocaine and methamphetamine—carries a prison sentence of 10 years to life and a fine of up to

185 Id. at 142-43.
186 See United States v. Nelson, 383 F.3d 1227, 1230 (10th Cir. 2004).
187 United States v. McIver, 470 F.3d 550, 564 (4th Cir. 2006).
188 United States v. Feingold, 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).
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$10 mil ion for an individual or a fine of up to $50 mil ion for an organization.193 Penalties
increase for second or subsequent offenses, or if death or serious bodily injury results from the
use of the controlled substance.194 Compared with the CSA’s registration provisions, the Act’s
trafficking provisions general y entail greater potential liability—particularly for individual
defendants—but also 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.196 Companies and individuals
may also be subject to federal criminal charges under the Racketeer Influenced and Corrupt
Organizations Act197 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.200
Legal Considerations for the 117th Congress
Drug regulation has received significant attention from Congress in recent years, prompting a
range of proposals concerning the opioid epidemic; the proliferation of synthetic drugs, in
particular analogues to the opioid fentanyl; the divergence between the status of marijuana under
state and federal law; the ability of researchers to conduct clinical research involving Schedule I
controlled substances; and the response to the COVID-19 pandemic.
Opioid Crisis
One salient current issue in the realm of control ed substance regulation is the opioid epidemic.
Opioids are drugs derived from the opium poppy or emulating the effects of opium-derived

193 Id. § 841(b)(1)(A).
194 Id. § 841(b).
195 A violation of the CSA’s recordkeeping and reporting requirements requires only a showing of negligence. 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.
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drugs.201 Some opioids have legitimate medical purposes, primarily related to pain management,
while others have no recognized medical use.202 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.203 The
CDC reports that overdoses of prescription and nonprescription opioids claimed over 50,000 lives
in 2019.204 CDC researchers further estimate that the misuse of prescription opioids alone cost the
United States $78.5 bil ion in 2013.205
In recent years, the opioid crisis has prompted various legislative proposals aiming to prevent the
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)206 and the
21st Century Cures Act (Cures Act).207 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.208 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.209
Key amendments to the CSA under the SUPPORT Act included provisions expanding access to
medication-assisted treatment for opioid addiction,210 specifying the factors for determining
whether a controlled substance analogue is intended for human consumption,211 revising the
factors DEA considers when establishing opioid production quotas,212 and codifying the
definition of “suspicious order” and outlining the CSA’s suspicious order reporting
requirements.213

201 See CRS Report R44987, The Opioid Epidemic and Federal Efforts to Address It: Frequently Asked Questions, by
Lisa N. Sacco and Erin Bagalman. T echnically, the term “ opiates” refers to natural compounds found in the opium
poppy, while the term “ opioids” refers to synthetic compounds that emulate the effects of opiates, but commentators
often use the term “opioids” to refer to both categories of substances, and this report adopts that usage. See id.
202 Id.
203 Id.
204 See American Hospital Association, CDC: Drug overdose deaths up 4.6% in 2019 (July 16, 2020),
https://www.aha.org/news/headline/2020-07-16-cdc-drug-overdose-deaths-46-2019.
205 See Curtis S. Florence, et al., The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in
the United States, 2013, 54 MEDICAL CARE 901 (2016).
206 Pub. L. No. 114-198, 130 Stat. 695 (2016).
207 Pub. L. No. 114-255, 130 Stat. 1033 (2016).
208 See CRS 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.
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Notwithstanding the flurry of recent legal changes, numerous legislative proposals in the 116th
Congress sought to address the opioid crisis by further amending the CSA.214 For example, the
DEA Enforcement Authority Act of 2019215 would have made it easier for DEA to suspend a
registration. Specifical y, the bil would have lowered the threshold for what constitutes imminent
danger, al owing suspension upon a finding of “probable cause that death, serious bodily harm, or
abuse of a controlled substance wil occur in the absence of an immediate suspension of the
registration,” rather than the current statutory requirement of “a substantial likelihood of an
immediate threat that death, serious bodily harm, or abuse of a controlled substance wil occur in
the absence of an immediate suspension of the registration.”216 In addition, the John S. McCain
Opioid Addiction Prevention Act217 would have required medical practitioners applying for new
or renewed CSA registration to certify that they wil not prescribe more than a seven-day supply
of opioids for the treatment of acute pain.218 The LABEL Opioids Act219 would have amended the
CSA to require that opioids in Schedules II through V bear labels warning that they can cause
dependence, addiction, and overdose. Failure to comply with the labeling requirements would
have violated the CSA’s registration requirements.220 Other proposals sought to improve
treatment of opioid use disorder.221
Some proposals targeted specific opioids, especial y fentanyl.222 Fentanyl is a powerful opioid
that has legitimate medical uses such as pain management for cancer patients and patients on
ventilators.223 But, due to its potency, it also poses a particularly high risk of abuse, dependency,

214 Numerous additional proposals to address the opioid epidemic fall outside the scope of this report. For instance,
some proposals would amend the FD&C Act to increase liability for pharmaceutical companies or executives that
violate the FD&C Act. See, e.g., Opioid Crisis Accountability Act, S. 1584, 116th Cong. (2019). Others would provide
additional funding for local law enforcement efforts, opioid dependence treatment, or other related initiatives. See, e.g.,
Opioid T reatment Surge Act, S. 1662, 116th Cong. (2019); Budgeting for Opioid Addiction T reatment Act, S. 425,
116th Cong. (2019).
215 S. 424, 116th Cong. (2019).
216 Compare id. with 21 U.S.C. § 824(d)(2). For brief discussion of several additional bills from the 116th Congress that
would have altered the CSA’s registration requirements in an effort to combat the opioid crisis, see Emily Field, House
Passes Bipartisan Bills To Fight Opioid Crisis, Law360, Nov. 17, 2020.
217 H.R. 1614, 116th Cong. (2019); S. 724, 116th Cong. (2019).
218 T he bill includes exceptions for other types of treatment including management of chronic pain, end-of-life care,
and treatment of addiction.
219 H.R. 2732, 116th Cong. (2019); S. 1449, 116th Cong. (2019).
220 See 21 U.S.C. § 842(a)(4) (providing that it is unlawful “ to remove, alter, or obliterate a symbol or label required
by” the CSA).
221 See Strengthening Medicaid Coverage of MAT Act, S. 4674, 116th Cong. (2020) (clarifying that drugs and
biologicals used for medication-assisted treatment under Medicaid are subject to the requirements of the Medicaid
Drug Rebate Program); MAT E Act of 2020, S. 4640, 116th Cong. (2020) (requiring physicians and other prescribers of
controlled substances to complete training on treating and managing patients with opioid and other substance use
disorders); Easy MAT for Opioid Addiction Act, H.R. 2281, 116th Cong. (2019) (direct ing the Attorney General to
amend certain regulations so that practitioners may administer not more than 3 days’ medication to a person at one time
when administering narcotic drugs for the purpose of relieving acute withdrawal symptoms). T he Easy MAT for
Opioid Addiction Act passed the House on November 17, 2020. “ MAT ” stands for “ m edication-assisted treatment” and
refers to the combined use of medication and other services to treat addiction . See CRS In Focus IF10219, Opioid
Treatm ent Program s and Related Federal Regulations, by Johnathan H. Duff.
222 For additional discussion of fentanyl regulation, see infra “Analogue Fentanyl.”
223 See id.; CRS Insight IN11321, COVID-19: The Drug Enforcement Administration’s Regulatory Role, by Lisa N.
Sacco.
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and overdose.224 The Ending the Fentanyl Crisis Act of 2019225 would have amended the CSA to
reduce the amounts of fentanyl required to constitute a trafficking offense.226 That bil would have
also increased penalties applicable to offenses involving fentanyl and provided separate
procedures for emergency scheduling of synthetic opioids.227 The Screening Al Fentanyl-
Enhanced Mail Act of 2019228 sought to require screening of al inbound international mail and
express cargo from high-risk countries to detect and prevent the importation of il icit fentanyl and
other synthetic opioids. Final y, the Blocking Deadly Fentanyl Imports Act229 aimed to gather
information about the production of il icit fentanyl in foreign countries and to withhold bilateral
assistance from countries that fail to enforce certain controlled substance regulations.
Analogue Fentanyl
A related issue that garnered significant attention in the 116th Congress is the proliferation of
synthetic drugs, especial y synthetic opioids. In contrast to drugs derived from natural materials
such as plants, synthetic drugs are drugs that are chemical y produced in a laboratory; they may
have the same chemical structure as an existing natural drug or mimic the effects of an existing
drug using a different chemical structure.230 Many legal pharmaceutical drugs are synthetical y
produced.231 On the other hand, clandestine actors seeking to circumvent existing drug laws often
design synthetic drugs to mimic the effects of other drugs—or even produce similar but stronger
effects—but have chemical structures that have been slightly modified to circumvent existing
drug laws.232
One particular concern in this area relates to synthetic opioids, including fentanyl analogues and
other fentanyl-like substances. Prescription fentanyl is a Schedule II controlled substance;
multiple nonpharmaceutical substances related to fentanyl are controlled in Schedule I.233
However, experts have noted that it is relatively easy to manipulate the chemical structure of
fentanyl in order to produce new substances that are not included in the CSA’s schedules but may
have similar effects to fentanyl or pose other dangers if consumed.234 Since March 2011, DEA has

224 See DEA, Schedules of Controlled Substances: T emporary Placement of Fentanyl-Related Substances in Schedule I,
83 Fed. Reg. 5188, 5188-90 (Feb. 6, 2018).
225 S. 1724, 116th Cong. (2019).
226 T he Comprehensive Fentanyl Control Act, introduced in the 115th Congress, would likewise have reduced the
amount of fentanyl triggering criminal liability. See H.R. 1781, 115th Cong. (2017).
227 T he Comprehensive Fentanyl Control Act would have allowed for temporary scheduling of a substance if the DEA
Administrator found that “ the drug or other substance satisfies the criteria for being considered a synthetic opioid” and
“adding such drug or other substance to the definition of synthetic opioids will assist in preventing abuse or misuse of
the drug or other substance.” S. 1724, 116th Cong. (2019). For discussion of the current requirements for emergency
scheduling, see supra “ Emergency Scheduling.”
228 H.R. 4102, 116th Cong. (2019); S. 2323, 116th Cong. (2019).
229 H.R. 1098, 116th Cong. (2019); S. 400, 116th Cong. (2019).
230 See CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea.
231 See, e.g., Kevin R. Campos, et al., The Importance of Synthetic Chemistry in the Pharmaceutical Industry, SCIENCE,
Jan. 18, 2019.
232 Synthetic drugs that slightly modify the molecular structures of controlled substances to circumvent existing drug
laws may also be called “ designer drugs.” See CRS Report R42066, Synthetic Drugs: Overview and Issues for
Congress, by Lisa N. Sacco and Kristin Finklea.
233 See 21 C.F.R. §§ 1308.11, 1308.12.
234 See CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea.
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used its emergency scheduling authority235 to impose temporary controls on 74 synthetic drugs,
including 17 fentanyl-like substances.236
Even if not individual y scheduled under the CSA, fentanyl-like substances may be subject to
DEA control as controlled substance analogues.237 However, analogue controlled substance
prosecutions can be burdensome because they raise “complex chemical and scientific issues.”238
That is because liability for trafficking in controlled substance analogues requires proof that the
substance at issue (1) is intended for human consumption and (2) has either a chemical structure
substantial y similar to the chemical structure of a Schedule I or II control ed substance or an
actual or intended effect similar to or greater than that of a Schedule I or II controlled
substance.239 If fentanyl analogues were explicitly scheduled, proof of those additional elements
would not be necessary. Moreover, some synthetic drugs do not meet the applicable criteria to be
deemed controlled substance analogues—for example, because their effects are unpredictable or
because they replicate the effects of more than one class of drugs.240 DOJ has therefore argued
that permanent scheduling of fentanyl analogues can reduce uncertainty and aid enforcement.241
A key chal enge in permanently scheduling fentanyl analogues is how to define the substances
subject to regulation. Not al analogues of fentanyl have effects similar to fentanyl itself, and due
to the large number of potential analogues there are many whose effects are unknown.242 On one
hand, defining covered substances based on chemical structure may be overinclusive because the
definition may include inactive substances, potential y al owing for prosecution of individuals
who possess substances that pose no threat to public health and safety.243 On the other hand, such
a definition may also be underinclusive because it excludes opioids that are not chemical y related
to fentanyl or that are made using different modifications to fentanyl’s chemical structure.244
Alternatively, defining covered opioids based on their effects rather than their chemical structure
would do little to reduce the burden that prosecutors currently face when bringing analogue
controlled substance charges.245
The 116th Congress did not permanently schedule fentanyl analogues, but it did take action to
facilitate DEA’s regulation of those substances. In February 2018, DEA issued an emergency
scheduling order that applied broadly to “fentanyl-related substances” that meet certain criteria
related to their chemical structure.246 The temporary scheduling order was set to expire in

235 See supra “Emergency Scheduling.”
236 See Fentanyl Analogues: Perspectives on Classwide Scheduling: Hearing Before the House Comm. on the Judiciary,
116th Cong. 2 (2019) (statement of the U.S. Dep’t of Justice).
237 See supra “Analogues and Listed Chemicals.”
238 DOJ T estimony, supra note 35 at 5.
239 21 U.S.C. §§ 802(32), 813; see also DOJ T estimony, supra note 35 at 5.
240 See CRS Report R42066, Synthetic Drugs: Overview and Issues for Congress, by Lisa N. Sacco and Kristin Finklea.
241 DOJ T estimony, supra note 35 at 5.
242 DEA previously temporarily scheduled two fentanyl analogues before determ ining that the substances were
“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
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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.
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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.
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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-
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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
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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.
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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. United Nations Single Convention on
Narcotic Drugs, 1961, List of Drugs Included in Schedule I, Mar. 30, 1961, 18 U.S.T . 1407. T he 1961 Convention also
contains provisions imposing specific requirements on the cultivation of cannabis. Id. art. 28. In addition, T HC remains
subject to control under the Convention on Psychotropic Substances of 1971. United Nations Convention on
Psychotropic Substances, List of Substances in Schedule I, Feb. 21, 1971, 32 U.S.T . 543.
297 T he Supreme Court has held, “Only ‘[i]f the treaty contains stipulations which are self-executing, that is, require no
legislation to make them operative, [will] they have the force and effect of a legislative enactment. ’” Medellin v. T exas,
552 U.S. 491, 505-06 (2008). Congress has made explicit findings that the Convention on Psychotropic Substances “ is
not self-executing, and the obligations of the United States thereunder may only be performed pursuant to appropriate
legislation.” 21 U.S.C. § 801a(2). Because the enforcement provisions of the two treaties are similar, with neither
stating that it is self-executing, it appears the Single Convention on Narcotic Drugs also is not self-executing.
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do not have the same status as judicial y enforceable domestic law ; for example, an individual
would not be subject to prosecution on the basis of the treaties without some implementing statute
such as the CSA.298 However, failure to abide by its treaty obligations could expose the United
States to diplomatic consequences.299
Clinical Research and Use of Schedule I Substances
Another issue that received significant attention during the 116th Congress was the possibility
that certain Schedule I controlled substances, especial y marijuana and psilocybin, may have
medical benefits. As a legal matter, Schedule I status limits researchers’ ability to conduct clinical
research involving these substances and patients’ ability to access such substances for medical
purposes.
Because substances in Schedule I have no accepted medical use under the CSA, it is only legal to
produce, dispense, and possess those substances in the context of federal y approved scientific
studies.300 In addition, federal law limits the use of federal funding for such research: a rider to
the appropriations bil for FY2021 provides that no appropriated funds may be used “for any
activity that promotes the legalization of any drug or other substance included in schedule I” of
the CSA, except “when there is significant medical evidence of a therapeutic advantage to the use
of such drug or other substance or . . . federal y sponsored clinical trials are being conducted to
determine therapeutic advantage.”301
Schedule I status under the CSA raises two key legal issues related to medical use and clinical
research. First, some commentators have expressed concerns that the CSA places too many
restrictions on research involving controlled substances, particularly Schedule I controlled
substances that might have a legitimate medical use.302 With respect to clinical research involving
marijuana specifical y, currently there is one farm that legal y produces marijuana for research

298 See Medellin, 552 U.S. at 527 (“A non-self-executing treaty, by definition, is one that was ratified with the
understanding that it is not to have domestic effect of its own force.”). For additional background on the legal effect of
self-executing and non-self-executing treaties, see CRS Report RL32528, International Law and Agreem ents: Their
Effect upon U.S. Law, by Stephen P. Mulligan, at 15.
299 See United Nations Single Convention on Narcotic Drugs, 1961, art. 14, Mar. 30, 1961, 18 U.S.T . 1407 (authorizing
the Narcotics Control Board to recommend to treaty signatories that they stop the export or import of drugs to a
signatory country that violates the treaty, or to publish a report on any matter related to enforcement of the treaty);
United Nations Convention on Psychotropic Substances, art. 19, Feb. 21, 1971, 32 U.S.T . 543 (same). Some
commentators have suggested that it is possible state laws decriminalizing marijuana already conflict with the United
States’ obligations under the treaties. See Brian M. Blumenfeld, Pacta Sunt Servanda State Legislation of Marijuana
and Subnational Violations of International Treaties: A Historical Perspective , 46 PEPP . L. REV. 69, 94-101 (2018)
(while acknowledging that the “ operative articles of the drug treaties do, in fact, leave room for debate,” concluding
that “the constitutional authority of the federal government to enforce marijuana prohibition in all fifty states is well-
settled American law,” and, because the “ United States’ administrative-discretionary measures have thus far failed to
deter numerous subnational actors from engaging in commercialized recreational marijuana activity, and instead have
created a sphere of tolerance for its growth, the United States will remain vulnerable to ce nsure from members of the
international community”); Jonathan Remy Nash, Doubly Uncooperative Federalism and the Challenge of U.S. Treaty
Com pliance, 55 COLUM. J. T RANSNAT’L L. 3, 21-23 (2016) (“ Limits on federal government power notwithstanding,
strict application of the doctrine of state responsibility would seem to mean that U.S. state actions have put the United
States in breach [of its treaty obligations].”).
300 See 21 U.S.C. § 823(f); see also Gonzales v. Raich, 545 U.S. 1, 14 (2004).
301 Pub. L. No. 116-260, Div. H, § 509 (2020).
302 See, e.g., Michael H. Andreae, et al., An Ethical Exploration of Barriers to Research on Controlled Drugs, AM. J.
BIOETH., Apr. 2016, at 5-6, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4849133/pdf/nihms-778176.pdf.
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purposes, and researchers have complained that marijuana from that source is deficient in both
quality and quantity.303
Second, there is a growing gulf between federal and state law with respect to Schedule I
controlled substances with potential medical benefits. The gap between federal and state
regulation of medical—and recreational—marijuana is discussed in greater detail above.304 But,
following the 2020 election, it appears that a gap may also be developing with respect to certain
other Schedule I substances. On November 3, 2020, voters in Oregon approved a bal ot measure
authorizing the use of psilocybin for medical purposes under state law.305 The same day, District
of Columbia voters passed a bal ot measure deprioritizing the enforcement of criminal
prohibitions on certain psychedelic plants and fungi.306 The District of Columbia measure is not
limited to medicinal use but was motivated in part by the possibility that psychedelic substances
may provide medical benefits.307 As with marijuana, these changes in D.C. and state law do not
alter the status of the affected Schedule I control ed substances under the federal CSA but
potential y raise similar legal issues.308
Congress has previously acted to facilitate research involving marijuana while also retaining strict
controls over the Schedule I controlled substance, but regulatory delays have reduced the
potential impact of that action. In 2015, Congress passed the Improving Regulatory Transparency
for New Medical Therapies Act, which imposed deadlines on DEA to issue notice of each
application to manufacture Schedule I substances for research and then act on the application.309
Although DEA stated in 2016 that it planned to grant additional licenses to grow marijuana for
research purposes, it has not yet done so.310 Perhaps prompted by litigation related to the delay,
DEA published a notice in the Federal Register in August 2019 announcing an ongoing “policy
review process to ensure that the [marijuana] growers program is consistent with applicable laws

303 See CRS Report R44782, The Marijuana Policy Gap and the Path Forward, coordinated by Lisa N. Sacco; Pet. for
Writ of Mandamus at 13-15, In re Scottsdale Research Inst., No. 19-1120 (D.C. Cir. June 6, 2019).
304 See supra “Marijuana Policy Gap.”
305 See Lizzy Acker, Oregon Becomes First State to Legalize Psychedelic Mushrooms, OREGOINAN, Nov. 3, 2020.
T hrough a separate ballot measure, Oregonians voted to decriminalize possession of small amounts of certain Schedule
I and II controlled substances, including cocaine, heroin, oxycodone and methamphetamines. See Cleve R. Wootson Jr.
and Jaclyn Peiser, Oregon Decrim inalizes Possession of Hard Drugs, as Four Other States Legalize Recreational
Marijuana, WASH. POST, Nov. 4, 2020.
306 See Justin Wm. Moyer, D.C. Voters Approve Ballot Question to Decriminalize Psychedelic Mushrooms, WASH.
POST, Nov. 3, 2020. T he D.C. ballot measure does not repeal criminal laws related to psychedelic pla nts and fungi but
rather provides that prosecution for the use and sale of such substances shall be “ among the Metropolitan Police
Department’s lowest law enforcement priorities.” Id. T he ballot measure appears to have been tailored to comply with a
federal appropriations rider that prohibits the District of Columbia from expending any federal funds “ to enact or carry
out any law, rule, or regulation to legalize or otherwise reduce penalties associated with the possession, use, or
distribution of any schedule I substance under the Controlled Substances Act [.]” Pub. L. No. 116-93 Div. C, § 909, 133
Stat. 2317 (2019).
307 See Justin Wm. Moyer, D.C. Voters to Weigh in on ‘Magic Mushroom’ Decriminalization After Months-long
Cam paign, WASH. POST, Oct. 8, 2020. (“ In February, the D.C. Board of Elections approved the initiative after hearing
testimony from supporters who argued ibogaine, mescaline and the hallucinogen psilocybin, among other chemicals,
help people recover from post -traumatic stress syndrome and addict ion.”).
308 See CRS Legal Sidebar LSB10482, State Marijuana “Legalization” and Federal Drug Law: A Brief Overview for
Congress, by Joanna R. Lampe.
309 Pub. L. No. 114-89, 129 Stat.703 (2015); 21 U.S.C. § 823(i)(2). “Manufacturing” of controlled substances includes
growing marijuana. See, e.g., DEA, Bulk Manufacturer of Controlled Substances Applications: Bulk Manufacturers of
Marihuana, 84 Fed. Reg. 44,920 (Aug. 27, 2019) [hereinafter, DEA Notice].
310 See Pet. for Writ of Mandamus at 16, In re Scottsdale Research Inst., No. 19-1120 (D.C. Cir. June 6, 2019).
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The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress

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

311 Id.
312 DEA Notice at 44,921.
313 See DEA, Controls To Enhance the Cultivation of Marihuana for Research in the United States, 85 Fed. Reg.
82,333 (Dec. 18, 2020).
314 Id. at 82,353.
315 Id.
316 Id.
317 Id.
318 H.R. 601, 116th Cong. (2019).
319 H.Amdt. 321, 116th Cong. (2019). The amendment was not adopted.
320 See 165 Cong. Rec. H4612 (2019) (statement of Rep. Ocasio -Cortez) (“ I rise today to offer this critical bipartisan
amendment that will allow United States researchers to study and examine the extraordinary promise shown by several
schedule I drugs that have been shown in treating critical diseases, such as MDMA’s success in veteran PT SD,
psilocybin’s promise in treatment-resistant depression, or ibogaine’s effectiveness in opioid and other drug addiction.
Additionally, this will allow research into marijuana’s impact in cancer relief, seizure treatment, and more.”).
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COVID-19 Pandemic
The spread of COVID-19 in the United States beginning in early 2020 altered the daily lives of
mil ions of Americans and raised a wide range of legal issues.321 Issues relating to the CSA
include the supply of controlled substances used for treatment of COVID-19 and the prescription
of controlled substances via telemedicine.322
Supply of Controlled Substances
The COVID-19 pandemic has increased the demand for certain controlled substances for
legitimate medical purposes.323 In particular, Schedule II controlled substances such as fentanyl
and hydromorphone are used to relieve pain relief associated with intubation for patients on
ventilators.324 The CSA requires DEA to set aggregate production quotas for controlled
substances in Schedules I and II and for certain listed chemicals.325 DEA set the quotas for 2020
in December 2019.326 As COVID-19 spread in the United States in the spring of 2020, health care
providers became worried that existing supplies would be inadequate for the unprecedented
number of patients needing artificial ventilation and asked DEA to increase production quotas.327
In April 2020, DEA published a final order adjusting the 2020 production quotas for certain
Schedule II controlled substances, including fentanyl and hydromorphone, and the List I
chemicals ephedrine and pseudoephedrine.328
Increased production of controlled substances may raise concerns about increased potential for
diversion and abuse. The SUPPORT Act requires DEA to account for diversion when set ing
quotas for certain controlled substances, and DEA did so in revising the 2020 production
quotas.329 More general y, some worry that the pandemic wil lead to an increase in the misuse of
controlled substances as people across the country face il ness, anxiety, depression, and social
isolation due to the pandemic and related life changes.330 One July 2020 report described
“alarming spikes in drug overdoses” during the first months of the pandemic potential y driven by
“continued isolation, economic devastation and disruptions to the drug trade.”331

321 See CRS Legal Sidebar LSB10433, Legal Issues Related to the COVID-19 Outbreak: An Overview, coordinated by
Caitlain Devereaux Lewis.
322 For discussion of DEA’s role in responding to the COVID-19 pandemic, including DEA actions outside these two
areas, see CRS Insight IN11321, COVID-19: The Drug Enforcem ent Adm inistration’s Regulatory Role, by Lisa N.
Sacco.
323 See, e.g., Dan Levine, Exclusive: Opioid Supply Crunch for U.S. Coronavirus Patients Prompts Appeal to Relax
Lim its, REUTERS, Apr. 2, 2020.
324 See CRS Insight IN11321, COVID-19: The Drug Enforcement Administration’s Regulatory Role, by Lisa N. Sacco.
325 21 U.S.C. § 826(a); see also 21 C.F.R. § 1303.11.
326 See DEA, Established Aggregate Production Quotas for Schedule I and II Controlled Su bstances and Assessment of
Annual Needs for the List I Chem icals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2020 , 84 Fed. Reg.
66,014, (Dec. 2, 2019).
327 See, e.g., Dan Levine, Exclusive: Opioid Supply Crunch for U.S. Coronavirus Patients Promp ts Appeal to Relax
Lim its, REUTERS, Apr. 2, 2020.
328 DEA, Adjustments to Aggregate Production Quotas for Certain Schedule II Controlled Substances and Assessment
of Annual Needs for the List I Chem icals Ephedrine and Pseudoephedrine for 2020, in Response to the Coronavirus
Disease 2019 Public Health Em ergency, 85 Fed. Reg. 20,302 (Apr. 10, 2020).
329 See id. at 20,304-05.
330 See, e.g., CDC, Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic — United
States, June 24–30, 2020, MORBIDITY AND MORTALITY WEEKLY REPORT, Aug. 14, 2020.
331 William Wan & Heather Long, “Cries for Help”: Drug Overdoses Are Soaring During the Coronavirus Pandemic,
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The Controlled Substances Act (CSA): A Legal Overview for the 117th Congress

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

WASH. POST, July 1, 2020. See also Joseph Friedman et al., Overdose-Related Cardiac Arrests Observed by Em ergency
Medical Services During the US COVID-19 Epidem ic, JAMA PSYCHIATRY, Dec. 3, 2020.
332 See id. §§ 801(1), (2).
333 S. 4058, 116th Cong. (2020).
334 T elemedicine is also subject to regulation under legal authorities other than the CSA. See CRS Report R46239,
Telehealth and Telem edicine: Frequently Asked Questions, by Victoria L. Elliott .
335 Lisa M. Koonin, et al., Trends in the Use of Telehealth During the Emergence of the COVID-19 Pandemic —
United States, January–March 2020, MORBIDITY AND MORTALITY WEEKLY REPORT, Oct. 30, 2020.
336 21 U.S.C. § 829. T he CSA does not mandate that Schedule V controlled substances be distributed by prescription,
but such substances may be dispensed only “ for a medical purpose.” Id. § 829(c). 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. 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); Fl. 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).
337 21 U.S.C. § 829(e).
338 21 U.S.C. § 829(e)(2); see also DEA, COVID-19 Information Page,
https://www.deadiversion.usdoj.gov/coronavirus.html (accessed Dec. 2, 2020).
339 21 U.S.C. §§ 829(e)(2), 802(54).
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Act340 when the practice “involves patients located in such areas, and such controlled substances,
as the [HHS] Secretary, with the concurrence of the Attorney General, designates.”341 On January
31, 2020, the HHS Secretary issued a determination that a public health emergency exists under
the Public Health Service Act “[a]s a result of confirmed cases of 2019 Novel Coronavirus.”342
Subsequently, citing the CSA’s exception for telehealth services during a declared public health
emergency, DEA issued guidance on its website authorizing the use of telemedicine.343 DEA
stated that on March 16, 2020, the HHS Secretary (with the concurrence of the acting DEA
Administrator) applied the public health emergency exception to “al schedule II-V controlled
substances in al areas of the United States.” Thus, subject to applicable federal and state laws and
other conditions,344 from March 16, 2020, until the expiration of the public health emergency
related to COVID-19, DEA-registered practitioners anywhere in the United States may prescribe
any pharmaceutical controlled substance via telemedicine without conducting an in-person
medical evaluation.345
Numerous proposals before the 116th Congress sought to increase access to telehealth care during
the COVID-19 pandemic or maintain advances in telemedicine after the pandemic ends. The
Telehealth Act, among other things, would have al owed practitioners to prescribe controlled
substances in Schedule III or Schedule IV based on a telehealth visit.346 A number of other
legislative proposals addressed regulation of telemedicine outside the scope of the CSA.347 If
similar proposals are introduced in the 117th Congress, legislators may consider whether they
would affect the prescribing of controlled substances via telemedicine and whether they should
include specific provisions related to the CSA.

340 42 U.S.C. § 247d.
341 21 U.S.C. § 802(54)(D). T he statute provides that “ such designation shall not be subject to the procedures prescribed
by subchapter II of chapter 5 of title 5,” i.e., the Administrative Procedure Act. Id. § 802(54)(D)(ii).
342 Alex M. Azar II, Determination that a Public Health Emergency Exists (Jan. 31, 2020)
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019 -nCoV.aspx. T he determination has been renewed
several times, most recently in October 2020. Alex M. Azar II, Determination that a Public Health Emergency Exists
(Oct. 2, 2020) https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19 -2Oct2020.aspx.
343 DEA, COVID-19 Information Page, https://www.deadiversion.usdoj.gov/coronavirus.html (accessed Dec. 2, 2020).
344 T he applicable conditions for the use of telemedicine to prescribe controlled substances during the current public
health emergency are: (1) t he prescription is “ issued for a legitimate medical purpose by a practitioner acting in the
usual course of his/her professional practice,” (2) t he “ telemedicine communication is conducted using an audio -visual,
real-time, two-way interactive communication system,” and (3) t he prescribing practitioner is acting in accordance with
applicable federal and State laws.
345 DEA specifically noted: “ If the prescribing practitioner has previously conducted an in-person medical evaluation of
the patient, the practitioner may issue a prescription for a controlled substance after having communicated with the
patient via telemedicine, or any other means, regardless of whether a public health emergency has been declared by the
Secretary of Health and Human Services, so long as the prescription is issued for a legitimate medical purpose and the
practitioner is acting in the usual course of his/her professional practice. In addition, for the prescription to be valid, the
practitioner must comply with applicable Federal and State laws.”
346 H.R. 7992, 116th Cong. (2020). Legislative proposals to reform CSA regulation of telemedicine are not limited to
addressing the COVID-19 pandemic. For instance, the MET H Addiction Act, S. 2244, 116th Cong. (2019), would have
amended the CSA to allow community addiction treatment facilities and community mental health facilities to register
to dispense controlled substances through the practice of telemedicine. See also Improving Access to Remote
Behavioral Health T reatment Act of 2019, H.R. 4131, 116th Cong. (2019).
347 See, e.g., Mental Health T elemedicine Expansion Act , H.R. 1301, 116th Cong. (2019); VA Mission T elehealth
Clarification Act , S. 3643, 116th Cong. (2020); T elehealth Modernization Act , H.R. 8727, 116th Cong. (2020).
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Author Information

Joanna R. Lampe

Legislative Attorney

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Congressional Research Service
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