Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis
Congressional research reportDec 18, 2018
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Legal Authorities Under the Controlled
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Updated December 18, 2018
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R45164
Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis
Summary
According to the Centers for Disease Control and Prevention, the annual number of drug
overdose deaths involving prescription opioids (such as hydrocodone, oxycodone, and
methadone) and illicit opioids (such as heroin and nonpharmaceutical fentanyl) has more than
quadrupled since 1999. A November 2017 report issued by the President’s Commission on
Combating Drug Addiction and the Opioid Crisis also observed that “[t]he crisis in opioid
overdose deaths has reached epidemic proportions in the United States ... and currently exceeds
all other drug-related deaths or traffic fatalities.” How the current opioid epidemic happened, and
who may be responsible for fueling it, are complicated questions, though reports suggest that
several parties likely played contributing roles, including pharmaceutical manufacturers and
distributors, doctors, health insurance companies, rogue pharmacies, and drug dealers and addicts.
Many federal departments and agencies are involved in efforts to combat opioid abuse and
addiction, including a law enforcement agency within the U.S. Department of Justice, the Drug
Enforcement Administration (DEA), which is the focus of this report.
The primary federal law governing the manufacture, distribution, and use of prescription and
illicit opioids is the Controlled Substances Act (CSA), a statute that the DEA is principally
responsible for administering and enforcing. The CSA and DEA regulations promulgated
thereunder establish a framework through which the federal government regulates the
manufacture, distribution, importation, exportation, and use of certain substances which have the
potential for abuse or psychological or physical dependence, including opioids. Congress enacted
the CSA in 1970 to facilitate the availability of controlled substances for authorized medical,
scientific, research, and industrial purposes, while also preventing these substances from being
diverted out of legitimate channels for illegal purposes such as drug abuse and drug trafficking
activities. The CSA aims to protect the public’s health and safety from dangers posed by highly
addictive or dangerous controlled substances that are diverted into the illicit market, while also
ensuring that patients have access to pharmaceutical controlled substances for legitimate medical
purposes such as the treatment of pain.
This report describes the current federal legal regime governing opioids and other controlled
substances under the CSA and its implementing regulations, including (1) the classification of
various plants, drugs, and chemicals into one of five schedules based on the substance’s medical
use, potential for abuse, and safety or dependence liability; (2) who must register with the DEA in
order to receive authorization to handle the substances (such as drug manufacturers, wholesale
distributors, doctors, hospitals, pharmacies, and scientific researchers); (3) what obligations
registrants must satisfy in order to maintain a valid registration (such as keeping records of drug
inventories and transactions, submitting reports to the DEA, and providing security measures to
safeguard controlled substances); and (4) the DEA’s administrative, civil, and criminal authorities
for enforcing regulatory compliance with the CSA (such as suspending or revoking a registrant’s
legal authority to handle controlled substances if the DEA Administrator finds that the registrant
has “committed such acts as would render his registration ... inconsistent with the public
interest.”). The report then examines DEA initiatives and actions taken, pursuant to its legal
authorities under the CSA, which specifically target the abuse of opioids. The report concludes by
describing the legislative response to the opioid epidemic, including a summary of the
amendments to the CSA made by legislation enacted by the 115th Congress, the Substance UseDisorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities
Act (P.L. 115-271).
Congressional Research Service
Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis
Contents
Brief Background on the Opioid Epidemic ..................................................................................... 3
Overview of the CSA ...................................................................................................................... 5
Scheduling of Controlled Substances ........................................................................................ 5
Emergency or Temporary Scheduling ................................................................................. 7
Scheduling in Order to Satisfy International Treaty Obligations ........................................ 8
Who Must Register with the DEA?........................................................................................... 8
Exceptions to the Registration Requirement ..................................................................... 10
Regulatory Obligations of Registrants Under the CSA........................................................... 10
Recordkeeping ................................................................................................................... 11
Security Measures .............................................................................................................. 11
Reporting .......................................................................................................................... 12
Quotas ............................................................................................................................... 13
Prescription Requirements ................................................................................................ 13
What Are the Potential Consequences for Violating the CSA? ............................................... 15
State Regulation of Controlled Substances ............................................................................. 17
DEA’s Legal Authorities for Enforcing the CSA .......................................................................... 18
Investigations .......................................................................................................................... 19
Enforcement Actions ............................................................................................................... 20
Letter of Admonition or Informal Hearing ....................................................................... 20
Administrative Proceedings to Deny, Revoke, or Suspend a Registration ....................... 20
Immediate Suspension Orders .......................................................................................... 22
DEA’s Response to the Opioid Abuse Crisis ................................................................................ 24
DEA Actions Against Registrants ........................................................................................... 24
Emergency Scheduling of Illicit Fentanyl ............................................................................... 28
Aggregate Production Quotas for Certain Schedule II Opioids .............................................. 29
Congressional Actions Addressing the Opioid Epidemic .............................................................. 30
Expanding Disposal Options for Unwanted Opioid Medication............................................. 30
Increasing Flexibility With Respect to Medication-Assisted Treatment for Opioid
Addiction.............................................................................................................................. 33
Providing Manufacturers and Distributors Certain ARCOS Data........................................... 35
Adding Considerations for DEA Opioid Quotas ..................................................................... 36
Strengthening Requirements to Detect and Report Suspicious Orders ................................... 36
Other Legislative Proposals That the 116th Congress Could Consider to Amend the CSA........... 37
Contacts
Author Contact Information .......................................................................................................... 39
Congressional Research Service
Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis
he alarming rise in drug overdose deaths involving opioids over the past two decades1
has prompted the federal government to examine the causes of the public health crisis,
identify possible solutions to counteract the problem, and take actions to address the
crisis.2 The primary federal law governing the manufacture, distribution, and use of
prescription and illicit opioids is the Controlled Substances Act (CSA or the act),3 which
is administered and enforced by the Drug Enforcement Administration (DEA) in the U.S.
Department of Justice.4 The CSA provides the legal regime through which the federal government
(1) regulates and facilitates the lawful production, possession, and distribution5 of controlled
substances, including opioids; (2) prevents diversion6 of these substances from legitimate
purposes; and (3) penalizes unauthorized activities involving controlled substances.7
T
The regulatory framework under the CSA relies primarily on a registration system: the act
requires persons who handle controlled substances (such as drug manufacturers, wholesale
distributors, exporters, importers, health care professionals, hospitals, pharmacies, and scientific
researchers) to register with the DEA and comply with the terms and conditions of the
registration.8 Through this registration mechanism, the CSA creates a “closed system” of
distribution9 in which distribution may lawfully occur among registered handlers of controlled
substances, referred to under the act as “registrants.”10 To monitor the amount of particularly
1 Centers for Disease Control and Prevention, Overdose Deaths Involving Opioids, Cocaine, and Psychostimulants—
United States, 2015–2016, 67 MORBIDITY AND MORTALITY WEEKLY REPORT No. 12 (Mar. 30, 2018),
https://www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm6712-H.pdf.
2 See, e.g., THE PRESIDENT’S COMMISSION ON COMBATING DRUG ADDICTION AND THE OPIOID CRISIS: FINAL REPORT
(2017); see also The Drug Enforcement Administration’s Role in Combating the Opioid Epidemic: Hearing Before the
H. Comm. on Energy & Commerce, Subcomm. on Oversight and Investigations, 115th Cong. (2018); Combating the
Opioid Crisis: Prevention and Public Health Solutions: Hearing Before the H. Comm. on Energy & Commerce,
Subcomm. on Health, 115th Cong. (2018); The Opioid Crisis: An Examination of How We Got Here and How We Move
Forward: Hearing Before the S. Comm. on Health, Educ., Labor & Pensions, 115th Cong. (2018); Oversight of the
Ensuring Patient Access and Effective Drug Enforcement Act: Hearing Before the S. Judiciary Comm., 115th Cong.
(2017); The Federal Response to the Opioid Crisis: Hearing Before the S. Comm. on Health, Educ., Labor & Pensions,
115th Cong. (2017).
3 Congress enacted the CSA as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, P.L. 91513, 84 Stat. 1236 (codified as amended at 21 U.S.C. §§ 801-904 (2012)).
4 While the CSA directs the Attorney General to enforce its provisions, the CSA also permits him to delegate such
responsibilities to any other officer or employee of the Department of Justice. 21 U.S.C. § 871(a). Pursuant to 28
C.F.R. § 0.100(b), the Attorney General has assigned much of the authority to implement and enforce the CSA to the
DEA Administrator. Accordingly, the term “DEA Administrator” will be used instead of the term “Attorney General”
with respect to any references in the CSA to the Attorney General for the remainder of this report.
5 The CSA broadly defines “distribution” to include virtually every transfer of possession. 21 U.S.C. § 802(11) (“The
term ‘distribute’ means to deliver (other than by administering or dispensing) a controlled substance or a listed
chemical.”).
6 The DEA has explained that the term “diversion,” used in the context of the CSA, refers to “the redirection of
controlled substances which may have lawful uses into illicit channels.” Drug Enf’t Admin., Controlled Substances
Quotas, 83 Fed. Reg. 32,784 (July 16, 2018).
7 This report focuses only on federal regulation of controlled substances under the Controlled Substances Act and does
not discuss other federal laws that may apply to controlled substance medications, such as the Federal Food, Drug, and
Cosmetic Act, P.L. 75-717, 52 Stat. 1057 (1938) (chiefly enforced by the U.S. Food and Drug Administration), or any
state laws pertaining to medical practices and public health and safety.
8 21 U.S.C. § 822. In addition, the CSA grants the DEA Administrator broad authority to issue rules and regulations
“relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances.... ” Id.
§ 821.
9 Drug Enf’t Admin., Electronic Prescriptions for Controlled Substances, 75 Fed. Reg. 16,236, 16,237 (Mar. 31, 2010).
10 According to 21 C.F.R. § 1300.02(b), the term “registrant” means “any person who is registered [with the DEA]
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dangerous drugs that enters this distribution system,11 the CSA requires the DEA to establish a
quota system that restricts the total amount of certain controlled substances that may be annually
produced or manufactured.12
In order to minimize theft and diversion and to help the DEA monitor the flow of controlled
substances in the United States,13 the CSA and its implementing regulations subject registrants to
strict requirements regarding recordkeeping, maintaining the security of their controlled
substance inventories, and reporting certain information to the DEA.14 The “closed system” of
distribution, along with registrant compliance with the CSA’s regulatory requirements, helps to
ensure that a particular controlled substance is always accounted for by a DEA-registered entity,15
from its creation until it is dispensed16 to a patient17 or is destroyed.18 Note that patients are not
required to register with the DEA19 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.”20
A registrant’s failure to meet its obligations under the CSA can result in a controlled substance
being diverted from legitimate channels. For example, “[d]istributors that blindly sell
pharmaceutical controlled substances to rogue pharmacies, and practitioners21 who issue
prescriptions without a legitimate medical purpose are diverting.”22 Such diversion can contribute
to drug abuse and addiction,23 which, in turn, increase the number of overdose deaths and
pursuant to [21 U.S.C. §§ 823 or 958].”
11 Improving Management of the Controlled Substances Quota Process, Hearing Before the S. Caucus on Int’l
Narcotics Control, 114th Cong. 2 (2015) (statement of Joseph T. Rannazzisi, DEA).
12 21 U.S.C. § 826(a).
13 Improving Predictability and Transparency in DEA and FDA Regulation: Hearing Before the H. Comm. on Energy
& Commerce, Subcomm. on Health, 113th Congress 1 (2014) (statement of Joseph T. Rannazzisi, DEA).
14 See, e.g., 21 C.F.R. § 1304.11(a) (“Each inventory shall contain a complete and accurate record of all controlled
substances on hand on the date the inventory is taken.... ”); id. § 1301.71(a) (“All applicants and registrants shall
provide effective controls to guard against theft and diversion of controlled substances.”); 21 U.S.C. § 832 (“Each
registrant shall—design and operate a system to identify suspicious orders for the registrant … and upon discovering a
suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration….”).
15 Improving Predictability and Transparency in DEA and FDA Regulation: Hearing Before the H. Comm. on Energy
& Commerce, Subcomm. on Health, 113th Congress 1 (2014) (statement of Joseph T. Rannazzisi, DEA).
16 The CSA defines “dispense” to mean “to deliver a controlled substance to an ultimate user or research subject by, or
pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and
the packaging, labeling or compounding necessary to prepare the substance for such delivery.” 21 U.S.C. § 802 (10).
17 The CSA refers to an individual patient as an “ultimate user,” meaning “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.” Id. § 802(27).
18 Drug Enf’t Admin., Definition and Registration of Reverse Distributors, 70 Fed. Reg. 22,591 (May 2, 2005).
19 21 U.S.C. § 822(c)(3).
20 DEA, Definition and Registration of Reverse Distributors, 68 Fed. Reg. 41,222, 41,226 (proposed July 11, 2003).
21 The CSA defines the term “practitioner” to mean “a 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).
22 Improving Predictability and Transparency in DEA and FDA Regulation: Hearing Before the H. Comm. on Energy
& Commerce, Subcomm. on Health, 113th Congress 2 (2014) (statement of Joseph T. Rannazzisi, DEA).
23 Id.
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emergency room visits, two defining features of the current opioid epidemic.24 In addition, some
users who abuse prescription opioids may also start using cheaper and potentially easier to obtain
illicit opioids such as heroin, which provide similar euphoric effects.25
The CSA provides civil and criminal penalties for any unlawful26 manufacture, distribution,
importation, exportation, or possession of controlled substances.27 Such violations may include
(1) “regulatory” offenses committed by registrants who do not adhere to their responsibilities
under the CSA, thereby increasing the risk of diversion, and (2) illicit trafficking or possession
crimes that occur outside the “closed system” of authorized controlled substance distribution that
primarily involve nonregistrants.28
This report first provides a brief overview of the opioid epidemic and then describes in greater
detail the current federal legal regime governing opioids and other controlled substances under
the CSA and its implementing regulations. After that, the report examines DEA actions taken that
are specifically targeted at addressing opioid abuse and describes recently enacted laws amending
the CSA that impact the opioid regulatory system, including the Substance Use-Disorder
Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (P.L.
115-271), enacted by the 115th Congress. The report concludes by discussing other legislative
options that the 116th Congress could consider to amend the CSA further to address the opioid
epidemic.
Brief Background on the Opioid Epidemic29
The Centers for Disease Control and Prevention (CDC) has declared that the nation “is in the
midst of an opioid overdose epidemic,” citing statistics that show the number of overdose deaths
involving opioids (including prescription opioids and illegal opioids such as heroin and
24 America’s Addiction to Opioids: Heroin and Prescription Drug Abuse, Hearing Before the S. Caucus on Int’l
Narcotics Control, 113th Cong. 3-4 (2014) (statement of Dr. Nora D. Volkow, Director, Nat’l Inst. on Drug Abuse); see
also Masters Pharm., Inc. v. DEA, 861 F.3d 206, 211 (D.C. Cir. 2017)(“Breakthroughs in the development of
prescription opioid painkillers have vastly increased their popularity. But that popularity has taken a toll. Opioids are
heavily addictive and often lethal in high doses.”).
25 Id. at 4, 8; see also Nat’l Inst. on Drug Abuse, Prescription Opioid Use is a Risk Factor for Heroin Use,
https://www.drugabuse.gov/publications/research-reports/relationship-between-prescription-drug-heroin-abuse/
prescription-opioid-use-risk-factor-heroin-use (last visited Apr. 3, 2018).
26 “Unlawful” in this context means any actions involving controlled substances that are not authorized under the CSA.
See Drug Enf’t Admin., Electronic Prescriptions for Controlled Substances, 75 Fed. Reg. 16,236, 16,237 (Mar. 31,
2010) (“The Controlled Substances Act is unique among criminal laws in that it stipulates acts pertaining to controlled
substances that are permissible. That is, if the CSA does not explicitly permit an action pertaining to a controlled
substance, then by its lack of explicit permissibility the act is prohibited.”).
27 21 U.S.C. §§ 841-865.
28 This report is focused primarily on the CSA’s noncriminal regulatory provisions pertaining to activities permitted by
the CSA. For a listing of the CSA’s criminal provisions regarding unauthorized trafficking, possession, or other
prohibited activities involving controlled substances, see CRS Report RL30722, Drug Offenses: Maximum Fines and
Terms of Imprisonment for Violation of the Federal Controlled Substances Act and Related Laws, by (name redacted)
.
29 For more information about the opioid epidemic, see CRS Report R44987, The Opioid Epidemic and Federal Efforts
to Address It: Frequently Asked Questions, by (name redacted) and (name redacted)
; CRS Report R45279, Buprenorphine
and the Opioid Crisis: A Primer for Congress, by (name redacted) ; CRS In Focus IF11041, The Opioid Epidemic
and the U.S. Labor Market, by (name redacted) and (name redacted)
; CRS In Focus IF10219, Opioid Treatment
Programs and Related Federal Regulations, by (name redacted) ; CRS Legal Sidebar LSB10226, State and Local
Governments Pursue Judicial Solutions to the Opioid Epidemic, by (name redacted) ; and CRS Report R45218, The
Opioid Epidemic and the Food and Drug Administration: Legal Authorities and Recent Agency Action, by (name redact
ed)
.
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nonpharmaceutical fentanyl) has more than quadrupled since 1999, and on average 115
Americans now die each day from an opioid overdose.30 Former Attorney General Jeff Sessions
referred to the opioid epidemic as “the deadliest drug crisis in American history,”31 and President
Trump in October 2017 directed the Secretary of Health and Human Services to declare the crisis
a national public health emergency.32
The CSA defines the term “opioid” to mean “any drug or other substance having an addictionforming or addiction-sustaining liability similar to morphine or being capable of conversion into a
drug having such addiction-forming or addiction-sustaining liability.”33 Opioids can include
prescription pain relief drugs34 such as hydrocodone, oxycodone, codeine, morphine, and
fentanyl,35 as well as illegal drugs such as heroin and nonpharmaceutical (illicitly produced)
fentanyl.36 While doctors may prescribe U.S. Food and Drug Administration (FDA)-approved
opioids to patients to alleviate their pain, particularly following surgery or injury or for serious
health conditions such as cancer, some individuals may choose to abuse opioids for nonmedical
reasons (such as to experience feelings of relaxation or to get “high”) or by taking them in a
higher dosage or through different means than prescribed by their doctor (such as by snorting or
injecting the substance into a vein).37 The CDC has estimated that more than 40% of all opioid
overdose deaths in the United States in 2016 involved an FDA-approved prescription opioid.38
How the opioid epidemic occurred, and who is responsible for fueling it, are complicated
questions, though reports have suggested that many parties are likely involved to some extent,
including pharmaceutical manufacturers39 and distributors,40 doctors,41 health insurance
30 Centers for Disease Control and Prevention, Opioid Overdose: Understanding the Epidemic, https://www.cdc.gov/
drugoverdose/epidemic/index.html (last visited Apr. 3, 2018).
31 Press Release, U.S. Dep’t of Just., Off. of Pub. Aff., Department of Justice Awards Nearly $59 Million to Combat
Opioid Epidemic, Fund Drug Courts (Sept. 22, 2017), https://www.justice.gov/opa/pr/department-justice-awardsnearly-59-million-combat-opioid-epidemic-fund-drug-courts.
32 U.S. DEP’T OF HEALTH & HUM. SRVS., DETERMINATION THAT A PUBLIC HEALTH EMERGENCY EXISTS (Oct. 2017),
https://www.hhs.gov/sites/default/files/opioid%20PHE%20Declaration-no-sig.pdf; see also Brianna Ehley, Trump
Administration Extending Opioid Emergency Declaration, POLITICO (Jan. 19, 2018, 8:14 PM),
https://www.politico.com/story/2018/01/19/trump-opioids-emergency-declaration-extension-300590. For information
about what the declaration of a public health emergency does to provide the Secretary of Health and Human Services
with additional authorities and resources to address the emergency, see U.S. Dep’t of Health & Hum. Srvs., Public
Health Emergency Declaration, https://www.phe.gov/Preparedness/legal/Pages/phedeclaration.aspx (last visited Apr.
11, 2018).
33 21 U.S.C. § 802(18).
34 Prescription drugs are medications that may be marketed in the United States only after the U.S. Food and Drug
Administration has approved their safety and effectiveness. For more information on this topic, see CRS Report
R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by (name redacted) and (name
redacted)
.
35 NAT’L INST. ON DRUG ABUSE, DRUG FACTS: PRESCRIPTION OPIOIDS 1 (Jan. 2018),
https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/drugfacts-prescriptionopioids.pdf.
36 Nat’l Inst. on Drug Abuse, Opioids, https://www.drugabuse.gov/drugs-abuse/opioids (last visited Apr. 11, 2018).
37
NAT’L INST. ON DRUG ABUSE, DRUG FACTS: PRESCRIPTION OPIOIDS 1-2 (Jan. 2018).
38 Centers for Disease Control and Prevention, Opioid Overdose: Prescription Opioid Overdose Data,
https://www.cdc.gov/drugoverdose/data/overdose.html (last visited Apr. 3, 2018).
39 Alana Semuels, Are Pharmaceutical Companies to Blame for the Opioid Epidemic?, THE ATLANTIC (June 2, 2017),
https://www.theatlantic.com/business/archive/2017/06/lawsuit-pharmaceutical-companies-opioids/529020/.
40 David Meyer & Geoffrey Smith, DEA Whistleblower Blasts Drug Distributors, Congress Over Opioid “Collusion,”
FORTUNE (Oct. 16, 2017), http://fortune.com/2017/10/16/rannazzisi-dea-drug-distributors-opioids/.
41 Mandy Oaklander, How Doctors Are Fueling the Opioid Epidemic, TIME (Feb. 17, 2017), http://time.com/4675325/
doctors-opioid-epidemic/.
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companies,42 rogue pharmacies,43 and drug dealers and addicts.44 The National Institute on Drug
Abuse has described the origins of the opioid overdose crisis as follows:
In the late 1990s, pharmaceutical companies reassured the medical community that patients
would not become addicted to prescription opioid pain relievers, and healthcare providers
began to prescribe them at greater rates. This subsequently led to widespread diversion and
misuse of these medications before it became clear that these medications could indeed be
highly addictive.45
The President’s Commission on Combating Drug Addiction and the Opioid Crisis46 also cited
excessive prescribing of opioids since 1999 as a significant contributor to the proliferation of
opioids.47 The commission identified several other factors that have influenced the current opioid
crisis, including large scale production and distribution of addictive opioids, widespread
availability of illicit heroin and fentanyl, unethical physician prescribing practices and rogue
pharmacies that fill those illegitimate prescriptions, and a lack of education for medical
professionals and patients in prescribing and using opioids, respectively.48
Overview of the CSA
This section provides a general overview of the CSA’s closed system of distribution that regulates
opioids and other types of controlled substances, including the schedules in which the substances
are placed and the regulatory requirements and obligations that registrants must satisfy, such as
(1) registering with the DEA, (2) keeping accurate and complete records of controlled substance
inventories and transactions, (3) implementing security measures to safeguard controlled
substances from theft or diversion, (4) reporting certain information to the DEA (including
suspicious controlled substance orders), (5) meeting production quotas, and (6) prescribing
controlled substances only for legitimate medical purposes.
Scheduling of Controlled Substances
The CSA places various plants, drugs, and chemicals (such as narcotics, stimulants, depressants,
hallucinogens, and anabolic steroids) into one of five schedules based on the substance’s medical
42 Katie Thomas & Charles Ornstein, Amid Opioid Crisis, Insurers Restrict Pricey, Less Addictive Painkillers, N.Y.
TIMES (Sept. 17, 2017), https://www.nytimes.com/2017/09/17/health/opioid-painkillers-insurance-companies.html.
43 Press Release, Drug Enf’t Admin. Pub. Aff., DEA Large-scale Operation Targets 26 Pharmacies in Three States in
Attack Against Illicit Opioid Abuse and Trafficking (Nov. 9, 2017), https://www.dea.gov/divisions/hq/2017/
hq120517.shtml.
44 Nathaniel Popper, Opioid Dealers Embrace the Dark Web to Send Deadly Drugs by Mail, N.Y. TIMES (June 10,
2017), https://www.nytimes.com/2017/06/10/business/dealbook/opioid-dark-web-drug-overdose.html.
45 Nat’l Inst. on Drug Abuse, Opioid Overdose Crisis, https://www.drugabuse.gov/drugs-abuse/opioids/opioidoverdose-crisis (last visited Apr. 3, 2018); see also Fentanyl: The Next Wave of the Opioid Crisis: Hearing Before the
H. Comm. on Energy & Commerce, Subcomm. on Oversight and Investigations, 115th Cong. 5 (2017) (statement of Dr.
Wilson Compton, Deputy Dir., Nat’l Inst. on Drug Abuse).
46 Established by Exec. Order No. 13,784, 82 Fed. Reg. 16,283 (Apr. 3, 2017).
47 THE PRESIDENT’S COMMISSION ON COMBATING DRUG ADDICTION AND THE OPIOID CRISIS: FINAL REPORT 19-23
(2017), https://www.whitehouse.gov/ondcp/presidents-commission/; see also Substance Abuse & Mental Health Srvs.
Admin., Prescription Drug Misuse and Abuse, https://www.samhsa.gov/topics/prescription-drug-misuse-abuse (last
visited Apr. 4, 2018) (“The problem of prescription drug abuse and overdose is complex, involving insufficient
oversight to curb inappropriate prescribing, insurance and pharmacy benefit policies, and a belief by many people that
prescription drugs are not dangerous.”).
48 Id.
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use, potential for abuse, and safety or dependence liability.49 Opioids are types of narcotic drugs.50
To restrict access to chemicals used in the illicit manufacture of certain controlled substances, the
CSA also regulates specified “listed chemicals.”51 Furthermore, the CSA regulates controlled
substance “analogues,” which are substances that are not controlled but have chemical structures
substantially similar to those of controlled substances found in Schedule I or II.52
The order of the five schedules in which controlled substances are categorized reflects substances
that are progressively less dangerous and addictive.53 Schedule I contains substances, such as the
hallucinogen lysergic acid diethylamide (LSD) and the illicit opioid heroin, that have “a high
potential for abuse” with “no currently accepted medical use in treatment in the United States”
and that cannot safely be dispensed under a prescription.54 Schedule I substances may be used
only for bona fide, federal government-approved research studies.55 In contrast, schedules II, III,
IV, and V include substances that have recognized medical uses, such as prescription opioids like
oxycodone, codeine, and morphine, and may be manufactured, distributed, prescribed, dispensed,
and possessed in accordance with the CSA.56
The CSA provides an administrative mechanism for substances to be controlled (added to a
schedule);57 decontrolled (removed from the scheduling framework altogether); and rescheduled
or transferred from one schedule to another.58 Federal rulemaking proceedings to add, delete, or
change the schedule of a drug or substance may be initiated by the DEA, the U.S. Department of
Health and Human Services (HHS), or by petition by any interested person.59 The DEA
Administrator must request from HHS a scientific and medical evaluation and recommendation as
to whether the drug or substance should be controlled or removed from control.60 The DEA
Administrator then must evaluate all of the relevant data and make a final determination as to
whether the drug or substance should be controlled or removed entirely from control.61
In making such determination, the DEA Administrator is required to consider statutory factors
such as the drug’s actual or relative potential for abuse; scientific evidence of its pharmacological
49 21 U.S.C. § 812(b).
50 21 C.F.R. § 1300.01 (definition of “narcotic drug”).
51 21 U.S.C. §§ 830; 802 (33-35). Listed chemicals are divided into two categories: List I and List II. While both
categories of chemicals can be used to manufacture controlled substances illicitly, List I chemicals are more
strenuously regulated under the CSA than List II chemicals because List I chemicals are “important to the manufacture
of the controlled substances.” Id. § 802(34).
52 Id. § 802(32)(A) and (B).
53 When Congress enacted the CSA in 1970, it established “initial schedules” of controlled substances, id. § 812(c), but
specified that the schedules “shall be updated” periodically, id. § 812(a). The current list of controlled substances
within their designated schedules may be found in 21 C.F.R. § 1308.11-15.
54 21 U.S.C. § 812(b).
55 Id. § 823(f).
56 Id. § 812(b).
57
The CSA defines the term “control” to mean “to add a drug or other substance, or immediate precursor, to a schedule
under [§ 812 of the act], whether by transfer from another schedule or otherwise.” Id. § 802(5).
58 Id. § 811 specifies the administrative scheduling procedures.
59 Id. § 811(a).
60 Id. § 811(b). The medical and scientific evaluations are binding on the DEA with respect to such matters and form a
part of the scheduling decision. The recommendation on the initial scheduling of a substance is binding only to the
extent that if HHS recommends that the drug or substance not be controlled, the DEA may not add it to its schedules.
Id.
61 Id.
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effect; the current state of scientific knowledge regarding the drug or substance; the risk to the
public health from the drug; and whether the substance is an immediate precursor62 of a substance
already controlled under the act.63 After the DEA Administrator makes this determination, he
must make specific findings concerning the drug or substance that dictate the schedule in which
the drug or substance will be placed.64
For example, in 2009, the DEA requested from HHS an evaluation and recommendation
concerning whether to reschedule hydrocodone combination products (HCPs) such as Vicodin®
from Schedule III to Schedule II.65 After evaluating the scientific and medical evidence showing,
among other things, significant diversion of HCPs and the health and safety risks created by
people who abuse HCPs, HHS then recommended to DEA that HCPs should be reclassified to the
more restrictive Schedule II,66 In 2014, DEA published a final rule that administratively
reschedules HCPs from Schedule III to Schedule II, thereby subjecting anyone who
manufactures, distributes, or dispenses HCPs to the more stringent regulatory requirements (and
administrative, civil, and criminal sanctions) that are applicable to Schedule II controlled
substances.67
Congress may also change the scheduling status of a drug or substance at any time through
enactment of legislation. For example, Congress passed the Synthetic Drug Abuse Prevention Act
of 201268 that permanently added two synthetic cathinones (central nervous system stimulants) to
Schedule I of the CSA, along with cannabimimetic substances (commonly referred to as synthetic
marijuana).69
Emergency or Temporary Scheduling
The CSA authorizes the DEA Administrator to place a drug or substance that is not currently
controlled, on a temporary basis, into Schedule I when he finds such scheduling “necessary to
avoid an imminent hazard to the public safety.”70 The DEA Administrator may not issue a
temporary scheduling order until 30 days after he notifies both the public and the HHS Secretary
of his intent to issue the temporary scheduling order and of his justification for issuing the order.71
Furthermore, the DEA Administrator must consider the HHS Secretary’s comments regarding the
62 The CSA defines an “immediate precursor” to mean a substance that (1) the DEA Administrator has determined to
be and has “designated as being the principal compound used, or produced primarily for use, in the manufacture of a
controlled substance;” (2) “is an immediate chemical intermediary used or likely to be used in the manufacture of such
controlled substance;” and (3) is necessary to control “to prevent, curtail, or limit the manufacture of such controlled
substance.” 21 U.S.C. § 802 (definition of “immediate precursor”).
63 See id. § 811(c)(1)-(8) (complete listing of factors the DEA Administrator must consider when determining control
or removal of substances from schedules).
64 See id. § 812(b) (“[A] drug or other substance may not be placed in any schedule unless the findings required for
such schedule are made with respect to such drug or other substance.”).
65 Drug Enf’t Admin., Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From
Schedule III to Schedule II, 79 Fed. Reg. 49,661, 49,662 (Aug. 22, 2014).
66 Id. at 49.663.
67 Id. at 49,680.
68 P.L. 112-144, 126 Stat. 1130 (2012).
69 For more information on this law and this topic generally, see CRS Report R42066, Synthetic Drugs: Overview and
Issues for Congress, by (name redacted) and (name redacted)
.
70 21 U.S.C. § 811(h)(1).
71 Id.
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temporary order.72 A drug or substance may be temporarily scheduled for two years and possibly
longer—up to an additional year—if formal scheduling procedures have been initiated.73 As
discussed below in the report, DEA has exercised its emergency scheduling authority eight times
to control seventeen substances structurally related to the opioid fentanyl by placing them
temporarily in Schedule I.74
Scheduling in Order to Satisfy International Treaty Obligations
Treaty obligations may require the DEA Administrator to control or reschedule a substance if
existing controls under federal law are less stringent than those required by a treaty. 75 The United
States is a party to three United Nations drug control treaties that impose certain international
obligations relating to the manufacture, distribution, use, and possession of controlled substances,
including the Single Convention on Narcotic Drugs of 1961,76 which was designed to establish
effective control over international and domestic traffic in narcotics, coca leaf, cocaine, and
marijuana.77 The United States is also party to the Convention on Psychotropic Substances of
1971,78 which was designed to establish similar control over stimulants, depressants, and
hallucinogens. Finally, the United States is a party to the 1988 Convention against Illicit Traffic in
Narcotic Drugs and Psychotropic Substances,79 which requires parties, among other things, to
control precursor chemicals used in the illicit manufacture of drugs and to take measures to
combat money laundering crimes related to drug trafficking.
Who Must Register with the DEA?
The CSA requires any person who seeks to manufacture, distribute, dispense, or conduct research
involving any controlled substance (such as drug manufacturers, wholesale distributors,
physicians, hospitals, pharmacies, and scientific researchers) to obtain a registration from the
72 Id. § 811(h)(4).
73 Id. § 811(h)(2).
74 Drug Enf’t Admin., Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in
Schedule I, 83 Fed. Reg. 5,188, 5,189 (Feb. 6, 2018).
75 The procedures for scheduling actions to meet obligations under international treaties are found at id. § 811(d).
76 Single Convention on Narcotic Drugs, Mar. 30, 1961, 18 U.S.T. 1407.
77 For example, in response to petitions from the public to transfer marijuana from Schedule I of the CSA to Schedule
II, the DEA explained how the United States obligations under the international drug control treaties constrain the
agency’s choice of schedules with respect to marijuana:
The DEA Administrator is obligated under [21 U.S.C.] section 811(d) to control marijuana in the
schedule that he deems most appropriate to carry out the U.S. obligations under the Single
Convention. It has been established in prior marijuana rescheduling proceedings that placement of
marijuana in either schedule I or schedule II of the CSA is ‘‘necessary as well as sufficient to
satisfy our international obligations’’ under the Single Convention. NORML v. DEA, 559 F.2d
735, 751 (D.C. Cir. 1977). As the United States Court of Appeals for the DC Circuit has stated,
‘‘several requirements imposed by the Single Convention would not be met if cannabis and
cannabis resin were placed in CSA schedule III, IV, or V.’’ Id. Therefore, in accordance with
section 811(d)(1), DEA must place marijuana in either schedule I or schedule II.
Drug Enf’t Admin., Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Reg. 53,687, 53,689
(Aug. 12, 2016).
78 Convention on Psychotropic Substances, Feb. 21, 1971, 32 U.S.T. 543.
79 Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, Dec. 20, 1988, S. TREATY DOC.
No. 101-4 (1989).
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DEA,80 unless they are exempt.81 Registrations specify the extent to which the DEA has
authorized registrants to manufacture, possess, distribute, or dispense controlled substances.82 The
DEA currently regulates more than 1.73 million registrants.83 The CSA authorizes the DEA
Administrator to charge reasonable fees relating to the registration and control of the
manufacturing, distribution, and dispensing of controlled substances under the act.84
The CSA directs the DEA Administrator to register an applicant if the Administrator determines
that, among other things, it would be consistent with the “public interest” to do so.85 The CSA
provides several criteria that the DEA Administrator must consider in assessing whether
registering an applicant is consistent with the “public interest.” The criteria differ depending on
the substance involved and whether the applicant is a manufacturer, distributor, or practitioner,
but include general factors such as those relating to public health and safety and compliance with
state and local laws.86 Manufacturers and distributors of controlled substances must obtain a
registration from the DEA annually, and those who dispense controlled substances must obtain
registrations that may not be issued for less than one year or more than three years.87 The
registration of an individual terminates when the person dies, ceases legal existence, or
discontinues business or professional practice.88 A registration cannot be transferred to someone
else unless the Administrator provides his express, written consent for such a transfer to occur.89
In some instances, applicants must apply for several separate registrations in order to comply with
the CSA. For example, separate registrations are generally required for each principal place of
business or professional practice where controlled substances are manufactured, distributed,
80 21 U.S.C. § 822(a).
81 Id. § 822(c) (agents of registrants, common carriers, and patients who lawfully possess controlled substances); 21
C.F.R. §§ 1301.23-1301.24 (certain military personnel, and law enforcement officials). These exemptions are discussed
in further detail in the next section.
82 21 U.S.C. § 822(b).
83
U.S. Dep’t of Just., FY 2019 Budget and Performance Summary – Drug Enforcement Administration (DEA) 2,
https://www.justice.gov/jmd/page/file/1033151/download (last visited Mar. 22, 2018).
84 21 U.S.C. § 821; see also 21 C.F.R. § 1301.13(e)(1) (chart detailing specific types of registrations and respective
fees). The DEA is required to set these fees at a level that ensures the recovery of the full cost of conducting its
controlled substance and chemical diversion control activities. 21 U.S.C. § 886a(1)(C).
85 Id. § 823(a). With respect to manufacturers of controlled substances in schedules I or II, the statute also requires the
DEA Administrator to determine whether such registration is consistent with “United States obligations under
international treaties, conventions, or protocols in effect on” May 1, 1971. Id.
86 Id. §§ 823(a)-(f).
87 Id. § 822(a). Registrants can seek to renew their registrations by submitting a renewal application to the DEA. U.S.
DEP’T OF JUST., DEA, RENEWAL APPLICATION FOR REGISTRATION UNDER CONTROLLED SUBSTANCES ACT OF 1970,
https://apps.deadiversion.usdoj.gov/webforms/jsp/regapps/common/renewalAppLogin.jsp (last visited Mar. 21, 2018).
In the renewal process, registrants must report any criminal activity they have engaged in and any other changes to their
professional or legal status that could impact their ability to handle controlled substances. U.S. DEP’T OF JUST., DEA
FORM 224A, RENEWAL APPLICATION FOR REGISTRATION, § 4, https://www.reginfo.gov/public/do/DownloadDocument?
objectID=9770701 (last visited Mar. 21, 2018). For example, a registrant must notify the DEA of any criminal
convictions against the registrant in connection with controlled substances and any suspension, revocation, restriction,
or denial of the registrant’s state license or registration relating to controlled substances. Id. See also U.S. GOV’T
ACCOUNTABILITY OFF., GAO-16-310, DEA SHOULD TAKE ADDITIONAL ACTIONS TO REDUCE RISKS IN MONITORING THE
CONTINUED ELIGIBILITY OF ITS REGISTRANTS 22 (2016) (“If the registrant does not self-report any liabilities and there
are no changes to the information contained in the registrant’s record (such as changes to the registrant’s name, address,
or state license number), then the renewal is automatically approved without further checks against state licensure
websites.”).
88 21 C.F.R. § 1301.52(a).
89 Id. § 1301.52(b).
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imported, exported, or dispensed.90 For example, a physician who is regularly engaged in
dispensing controlled substances at one location must register to dispense controlled substances at
other locations if he chooses to dispense controlled substances at these other locations.91
Exceptions to the Registration Requirement
The CSA allows for exceptions and also exempts certain individuals from some or all of its
regulatory requirements. For example, individuals exempted from registration requirements
include, among others, officers or employees of the DEA, officers of the U.S. Customs Service,
offers or employees of the FDA, and any other federal officers who are authorized to possess,
import, or export controlled substances in the course of their official duties.92 Officers or
employees of any state, or political subdivision of a state, who are engaged in enforcement of
state or local laws relating to controlled substances, are also exempt from registering with the
DEA.93 A person who has lawfully obtained, and who possesses, a controlled substance for his
own legitimate medical use (a patient) is also not required to register.94
In addition, only those actually engaged in activities relating to manufacturing, distributing, and
dispensing controlled substances are required to obtain registration, but related or affiliated
persons who are not engaged in such activities are not required to register. For example, a
stockholder or parent corporation of a corporation that manufactures controlled substances is not
required to obtain registration, nor are employees of a registered manufacturer, distributor, or
dispenser.95
The DEA Administrator may, by regulation, waive the registration requirement for certain
manufacturers, distributors, or dispensers, if he finds it consistent with the public health and
safety.96
Regulatory Obligations of Registrants Under the CSA
The CSA imposes specific obligations on registrants in an effort to reduce the potential diversion
of controlled substances out of legitimate distribution channels.97 In particular, the CSA imposes
legal duties relating to (1) recordkeeping by registrants, (2) measures ensuring the secure storage
of controlled substances handled by registrants, (3) reporting certain information to the DEA, (4)
90 21 U.S.C. § 822(e)(1); 21 C.F.R. § 1301.12.
91 See United States v. Clinical Leasing Serv., Inc., 925 F.2d 120, 122 (5 th Cir. 1991) (explaining that the “plain
language” of 21 C.F.R. § 1301.12 requires that “a physician must be separately registered at each physical location in
which he administers controlled substances as a regular part of his professional practice.”).
92 21 C.F.R. § 1301.24(a)(1).
93 Id. § 1301.24(a)(2). For additional registration exceptions, see id. §§ 1301.22-1301.23.
94 21 U.S.C. § 822(c).
95 21 C.F.R. § 1301.11(a); 21 U.S.C. § 822(c).
96 21 U.S.C. § 822(d). For example, in November 2014, the DEA published a rule that waived the requirement of
registration for certain individuals who directly administer a particular diagnostic pharmaceutical that contains a
radioactive component. Drug Enf’t Admin., Exemption From Registration for Persons Authorized Under U.S. Nuclear
Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product
DaTscan™, 79 Fed. Reg. 70,085 (Nov. 25, 2014). The DEA later removed this exemption after it had administratively
removed the radioactive component from the schedules of controlled substances. Drug Enf’t Admin., Removal of
Exemption From Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement, 81
Fed. Reg. 9,763 (Feb. 26, 2016).
97 Responding to the Prescription Drug Abuse Epidemic: Hearing Before the S. Caucus on Int’l Narcotics Control,
112th Cong. 4-5 (2012) (statement of Joseph T. Rannazzisi, DEA).
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prescribing and dispensing controlled substance medications by registered doctors and
pharmacists, and (5) the quantity of controlled substance that may be produced by manufacturers.
Recordkeeping
All registrants are required by the CSA to maintain complete and accurate inventories and records
of all regulated transactions involving controlled substances and listed chemicals.98 For example,
a registrant must make a complete and accurate record of each substance manufactured, received,
sold, delivered, or otherwise disposed of by the registrant.99 Furthermore, inventories must be
available for inspection by the DEA for at least two years.100 The CSA declares that it is unlawful
for any person to “refuse or negligently fail to make, keep, or furnish any record, report,
notification, declaration, order or order form, statement, invoice, or information required” by the
CSA.101 It is also unlawful for any person knowingly or intentionally “to furnish false or
fraudulent material information in, or omit any material information from, any application, report,
record, or other document required to be made, kept, or filed” under the CSA.102
In certain circumstances, the CSA recordkeeping provisions do not apply. For example, the
provisions do not apply to the prescribing or administering of a controlled substance listed in
Schedules II-V by practitioners acting in the lawful course of their professional practice unless
such substance is prescribed or administered in the course of maintenance or detoxification
treatment of an individual.103 As discussed below, this has implications for the drugs typically
used in the treatment of opioid addiction, two of which are controlled substances, while the other
is not.
Security Measures
For the purposes of ensuring the secure storage and distribution of controlled substances and
listed chemicals, all applicants for DEA registration and registrants must generally “provide
effective controls and procedures to guard against theft and diversion of controlled substances.”104
DEA regulations also detail specific security requirements for different types of applicants and
registrants. For example, nonpractitioners (i.e., manufacturers, distributors, and narcotic treatment
programs) are required to store Schedule I and II substances in electronically monitored safes,
steel cabinets, or vaults that meet or exceed certain specifications.105 Licensed practitioners must
store controlled substances in a “securely locked, substantially constructed cabinet”106 and must
notify the DEA of the theft or significant loss of any controlled substances within one business
98 21 U.S.C. § 827(a).
99 Id. § 827(a)(3); 21 C.F.R. § 1304.21(a).
100 21 U.S.C. § 827(b)(3); 21 C.F.R. § 1304.04(a).
101 21 U.S.C. § 842(a)(5).
102 Id. § 843(a)(4).
103 Id. §§ 827(c)(1)(A), 827(c)(1)(B). Thus, the prescribing or administering of methadone for the treatment of narcotic
addiction must be in conformity with the CSA’s recordkeeping provisions.
104 21 C.F.R. § 1301.71 (general security requirements and standards for measuring compliance); see also 21 U.S.C. §
823 (requiring the DEA Administrator, when determining whether a registration is consistent with the public interest, to
consider if the applicant or registrant has in place “effective controls against diversion.”).
105 See 21 C.F.R. §§ 1301.72(a)(1)(i)-(iii) (specifications required for safes and steel cabinets storing Schedule I and II
drugs or substances); see also id. §§ 1301.72(a)(2) and 1301.72(a)(3)(i)-(vi) (specifications required for vaults storing
Schedule I and II drugs or substances).
106 See id. § 1301.75 (physical security controls for practitioners).
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day of discovering such loss or theft.107 Furthermore, all practitioners are prohibited from hiring
employees who have been convicted of a drug-related felony or who have had a DEA registration
denied or revoked.108 DEA regulations recommend that nonpractitioners carefully screen
individuals before hiring them as employees, to ensure that job applicants do not have convictions
for crimes or have not engaged in unauthorized use of controlled substances.109
Reporting
The CSA requires manufacturers, distributors, and pharmacies to report periodically to the DEA
every sale, delivery, disposal, or dispensing of any controlled substance.110 Registered pharmacies
that are authorized to dispense controlled substances by means of the internet must also report to
the DEA Administrator the type and total quantity of each controlled substance that the pharmacy
has dispensed each month via the internet.111 In addition, the CSA requires manufacturers,
distributors, and dispensers of controlled substances (1) to design and operate a system (that is
compliant with applicable federal and state privacy laws) that will alert the registrant of
suspicious orders of controlled substances, and (2) upon discovering a suspicious order or series
of orders, to inform the DEA Administrator and the Special Agent in Charge of the DEA Field
Division Office.112 The CSA defines “suspicious orders” as those that may include, but are not
limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders
of unusual frequency.113
Manufacturers and distributors of Schedule I and II drugs must file reports114 with the DEA
through the Automated Reports and Consolidated Orders System (ARCOS),115 which is an
automated drug reporting system that allows the agency to “monitor[] the flow of DEA controlled
substances from their point of manufacture through commercial distribution channels to point of
sale or distribution at the dispensing/retail level.... ”116 Certain narcotics listed in Schedules III
and IV are also covered by the ARCOS reporting requirements.117 According to the DEA, U.S.
attorneys and DEA investigators may use ARCOS controlled substances transaction information
“to strengthen criminal cases in the courts.”118
107 Id. § 1301.76(b).
108 Id. § 1301.76(a).
109 Id. § 1301.90.
110 21 U.S.C. § 827(d).
111 Id. § 827(d)(2). However, pharmacies are exempt from such reporting requirement if they do not exceed in a given
month either of two thresholds: (1) 100 or more prescriptions dispensed, or (2) 5,000 or more dosage units of all
controlled substances combined. Id.
112 Id. § 832, as added by P.L. 115-271, § 3292(b).
113 21 U.S.C. § 802(57), as added by P.L. 115-271, § 3292(a).
114 21 C.F.R. §§ 1304.31 and 1304.32.
115 Id. § 1304.33.
116 Drug Enf’t Admin., Automation of Reports and Consolidated Orders System (ARCOS),
https://www.deadiversion.usdoj.gov/arcos/index.html (last visited Apr. 4, 2018).
117 21 C.F.R. § 1304.33(d).
118 Drug Enf’t Admin., Automation of Reports and Consolidated Orders System (ARCOS),
https://www.deadiversion.usdoj.gov/arcos/index.html (last visited Apr. 4, 2018).
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Quotas
The CSA includes a production quota system that requires the DEA to establish the total amount
of each basic class of Schedule I and II controlled substances and certain listed chemicals119 that
may be manufactured in a given calendar year, in order “to provide for the estimated medical,
scientific, research, and industrial needs of the United States, for lawful export requirements, and
for the establishment and maintenance of reserve stocks.”120 The DEA establishes this quota,
referred to as the aggregate production quota (APQ), for approximately 200 Schedule I and II
controlled substances.121 The DEA assigns individual production quotas to controlled substance
manufacturers that prevent the APQ from being exceeded.122 The CSA allows a registrant to apply
for an increase in his individual manufacturing quota if it is necessary “to meet his estimated
disposal, inventory, and other requirements during the remainder of that year.”123
By regulation, the DEA Administrator must consider the following factors in making his APQ
determinations: (1) the total disposal of the controlled substance during the current year and two
preceding years; (2) trends in the national rate of new disposal of the controlled substance; (3)
total inventories (actual or estimated) of “the class and all substances manufactured from the class
[of controlled substances listed in Schedule I or II];” (4) projected demand for a particular
controlled substance; (5) the extent of any diversion of the controlled substance in the class; (6)
relevant information obtained from the Department of Health and Human Services and from the
states; and (7) other relevant factors affecting the use of controlled substances including changes
in the currently accepted medical use of a controlled substance, the economic and physical
availability of the raw materials necessary to produce a controlled substance, and recent
unforeseen emergencies (i.e., natural disasters).124
A registrant may not manufacture a Schedule I or II controlled substance or a specified listed
chemical that is (1) not expressly authorized by his registration and by the individual quota
assigned to him by the DEA, or (2) in excess of that quota.125
Prescription Requirements
The CSA provides specific requirements that practitioners and pharmacists must observe when
prescribing and dispensing controlled substances in Schedules II-V to patients for legitimate
medical purposes.126 As noted, controlled substances classified as Schedule I drugs are deemed to
have no accepted medical purpose in the United States, and thus they may only be used for
research,127 and may not be prescribed or dispensed to patients.128 DEA regulations hold both the
119 These listed chemicals are ephedrine, pseudoephedrine, and phenylpropanolamine, which are ingredients commonly
found in over-the-counter cold medicines that may be used in the production of methamphetamine and amphetamine.
Drug Enf’t Admin., CMEA (Combat Methamphetamine Epidemic Act) Questions & Answers,
https://www.deadiversion.usdoj.gov/meth/q_a_cmea.htm (last visited Apr. 10, 2018).
120 21 U.S.C. § 826(a)(1).
121 Improving Management of the Controlled Substances Quota Process, Hearing Before the S. Caucus on Int’l
Narcotics Control, 114th Cong. 3 (2015) (statement of Joseph T. Rannazzisi, DEA).
122 21 U.S.C. § 826(b).
123 See id. § 826(e).
124 21 C.F.R. §§ 1303.11(b)(1)-(7).
125 21 U.S.C. §§ 842(b).
126 Id. § 829.
127 Id. § 823(f).
128 Id. § 812(b)(1).
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prescribing practitioner and the pharmacist who fills the prescription responsible for ensuring that
the controlled substance is properly prescribed and dispensed.129 A DEA manual prepared for
pharmacists to help them understand their obligations under the CSA explains that
A pharmacist is required to exercise sound professional judgment when making a
determination about the legitimacy of a controlled substance prescription. Such a
determination is made before the prescription is dispensed. The law does not require a
pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. To
the contrary, the pharmacist who deliberately ignores a questionable prescription when
there is reason to believe it was not issued for a legitimate medical purpose may be
prosecuted along with the issuing practitioner, for knowingly and intentionally distributing
controlled substances.130
Practitioners
Under the CSA, only licensed medical practitioners are authorized to prescribe controlled
substances listed in Schedules II-V to patients.131 A prescription for a controlled substance must
be “issued for a legitimate medical purpose by an individual practitioner acting in the usual
course of his professional practice.”132 A pharmacist may not dispense to a patient a Schedule II
controlled substance without a written prescription133 from a practitioner, except in certain cases
where the practitioner administers the controlled substance directly to the patient.134 However, in
the case of an “emergency situation,”135 a practitioner may orally authorize a pharmacist to fill a
prescription for a Schedule II controlled substance.136 Controlled substances in Schedules III-V
may be dispensed by a pharmacy pursuant to either a written or oral prescription, including a
facsimile of a written prescription.137 These substances may also be administered or dispensed
directly by the practitioner in the course of his professional practice without a prescription.138
Practitioners are permitted to sign and transmit electronic prescriptions for controlled substances,
129 21 C.F.R. § 1306.04(a) (“The responsibility for the proper prescribing and dispensing of controlled substances is
upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the
prescription.”).
130 DRUG ENF’T ADMIN., PHARMACIST’S MANUAL 30 (2010). See also Drug Enf’t Admin., A Pharmacist’s Guide to
Prescription Fraud, https://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm (last visited Dec. 12, 2018)
(“The dispensing pharmacist must maintain constant vigilance against forged or altered prescriptions. The law holds the
pharmacist responsible for knowingly dispensing a prescription that was not issued in the usual course of professional
treatment.”).
131 See 21 C.F.R. § 1306.03 (persons entitled to issue prescriptions).
132 Id. § 1306.04(a)(1); United States v. Moore, 423 U.S. 122, 124 (1975) (holding that “registered physicians can be
prosecuted” under 21 U.S.C. § 841 “when their activities fall outside the usual course of professional practice.”).
133 21 U.S.C. § 829(a); see also 21 C.F.R. § 1306.05 (manner of issuance of prescriptions for Schedule II controlled
substances).
134 21 U.S.C. § 829(a); see also 21 C.F.R. § 1306.11(b) (authorizing individual practitioners to administer or dispense
controlled substances directly to patients without prescription).
135 21 C.F.R. § 290.10 defines an “emergency situation” as a situation in which the prescribing practitioner finds that
(1) “immediate administration of the controlled substance is necessary” to treat the patient properly, (2) “no appropriate
alternative treatment is available,” including the use of a drug that is not a Schedule II controlled substance, and (3) “it
is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person
dispensing the substance, prior to the dispensing.”
136 21 U.S.C. § 829(a); 21 C.F.R. § 1306.11(d).
137 21 U.S.C. § 829(b). If the prescription is made orally, the pharmacist must promptly reduce to writing all of the
information required to be in a prescription under 21 C.F.R. § 1306.05, except for the signature of the practitioner. Id. §
1306.21(a).
138 21 U.S.C. § 829(b); 21 C.F.R. § 1306.21(b).
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assuming that the electronic prescription complies with detailed requirements set forth in the
applicable federal regulations.139
Pharmacists
Pharmacists may partially fill a prescription for Schedule II substances under certain
circumstances, such as pursuant to a request by the patient or the practitioner who wrote the
prescription.140 Pharmacists are prohibited from refilling prescriptions for Schedule II
substances.141 A pharmacist may fill or refill prescriptions for controlled substances in Schedules
III and IV, however, up to five times within six months after the date on which the prescription
was issued, unless the prescribing practitioner authorizes a renewal of the prescription.142 A
pharmacy may process electronic prescriptions for controlled substances if the pharmacy uses a
computer application that complies with several requirements specified in the applicable federal
regulations.143 A controlled substance that is a prescription drug may not be delivered, distributed,
or dispensed by means of the internet without a “valid prescription,”144 which the CSA defines as
a prescription that is issued for a legitimate medical purpose in the usual course of professional
practice by a practitioner who has conducted at least one medical evaluation of the patient in the
physical presence of the practitioner.145
What Are the Potential Consequences for Violating the CSA?
The CSA contains a variety of criminal sanctions for illicit possession, manufacture, and
distribution of controlled substances that occurs outside the closed system of distribution.146 For
example, the CSA outlaws “simple possession” of a controlled substance147 (referring to a person
knowingly or intentionally possessing a controlled substance) “unless such substance was
obtained directly, or pursuant to” a valid prescription issued by a medical practitioner, “or except
as otherwise authorized by” the CSA.148 The CSA also prohibits any person from knowingly or
139 Drug Enf’t Admin., Electronic Prescriptions for Controlled Substances, 75 Fed. Reg. 16,235, 16,307 (Mar. 31,
2010).
140 21 U.S.C. § 829(f).
141 Id. § 829(a) (“No prescription for a controlled substance in schedule II may be refilled.”).
142 Id. 829(b); 21 C.F.R. § 1306.22(a).
143 21 C.F.R. § 1311.205. The requirements include providing the pharmacy with the ability to sign digitally and
archive the controlled substance prescriptions and allowing the pharmacy to limit employee access for annotating,
altering, or deleting controlled substance prescription information. Id.
144 21 U.S.C. § 829(e).
145 Id.
146 Many of these criminal penalties appear in 21 U.S.C. § 841, which provides that “[e]xcept as authorized by” the
CSA, “it shall be unlawful for any person knowingly or intentionally” to commit the unlawful acts specified in §
841(a).
147
Generally speaking, the CSA’s simple possession statute is used to prosecute those found in possession of quantities
of controlled substances that are consistent with “personal use” amounts and when the evidence suggests that the
possession is for the purpose of personal use, rather than for resale or distribution. See United States v. Mack, 343 F.3d
929, 934 (8th Cir. 2003) (“We frequently rely on drug quantity as evidence of defendants’ intended purpose for
disposition of their drugs, i.e. personal use or sale.”).
148 21 U.S.C. § 844(a). With the exception of simple possession of flunitrazepam (commonly used as a “date rape”
drug), a first-time simple possession offense is a federal misdemeanor punishable by a maximum term of imprisonment
of 1 year. (Simple possession of flunitrazepam is punishable by a term of imprisonment of up to 3 years). Anyone who
commits a federal simple possession offense after a single prior conviction under federal or state drug laws is subject to
a mandatory minimum sentence of 15 days and up to 2 years in prison; those who have multiple prior drug offense
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intentionally acquiring or obtaining possession of a controlled substance by misrepresentation,
fraud, forgery, deception, or subterfuge.149 It is unlawful for any person knowingly or
intentionally to “traffic” in controlled substances; illegal drug trafficking150 generally refers to
distributing or dispensing, or to possessing with intent to distribute or dispense, a controlled
substance, unless the particular activity is authorized by law.151 The CSA’s criminal penalties for
trafficking in controlled substances vary depending on whether the individual is a first-time
offender or a repeat offender, the type of substance involved, and the quantity of the type of
substance involved.152 For example, a federal drug trafficking offense committed by a first-time
offender involving a Schedule II substance such as codeine is punishable by a term of
imprisonment of up to 20 years and a fine of up to $1,000,000.153 For a second offense, the fine
increases to $2,000,000 and the maximum imprisonment term increases to 30 years.154
The focus of this report, however, is on the CSA penalty provisions specifically applicable to
persons registered with the DEA. The CSA sets forth certain “regulatory” offenses involving
listed chemicals,155 failure to comply with CSA requirements and obligations that registrants must
satisfy as a condition of registration,156 and other prohibited acts by registrants who manufacture,
distribute and dispense controlled substances.157
For example, a registrant authorized to distribute or dispense any controlled substance is
prohibited from distributing, dispensing, or manufacturing controlled substances in a manner that
is not authorized by his particular registration.158 As noted above, registrants may not refuse or
negligently fail to maintain accurate records of controlled substances, and may not refuse to
convictions face a mandatory minimum sentence of 90 days and up to 3 years in prison. Id.
149 Id. § 843(a)(3). A violation of this may result in a term of imprisonment of not more than four years or a fine of up
to $250,000, or both; second offenses involving this section increase the maximum imprisonment term to eight years.
Id. § 843(d)(1).
150 The CSA and its implementing regulations do not define the term “traffic” or “trafficking,” though the CSA does
expressly use the term “drug traffickers” in one provision, 21 U.S.C. § 862, and the term “traffic” in three other
sections, id. §§ 801, 801a, 873. The U.S. Sentencing Guidelines, which greatly influence the sentences that federal
judges impose on those convicted of federal crimes, defines a “drug trafficking offense” as “an offense under federal,
state, or local law that prohibits the manufacture, import, export, distribution, or dispensing of, or offer to sell a
controlled substance (or a counterfeit substance) or the possession of a controlled substance (or a counterfeit substance)
with intent to manufacture, import, export, distribute, or dispense.” U.S.S.G. § 2L1.2, Application Notes (2). For more
information about the Sentencing Guidelines, see CRS Report R41696, How the Federal Sentencing Guidelines Work:
An Overview, by (name redacted)
.
151 21 U.S.C. § 841(a)(1).
152 For a listing of the CSA’s criminal provisions regarding unauthorized trafficking, possession, or other prohibited
activities involving controlled substances, see CRS Report RL30722, Drug Offenses: Maximum Fines and Terms of
Imprisonment for Violation of the Federal Controlled Substances Act and Related Laws, by (name redacted)
.
153 21 U.S.C. § 841(b)(1)(C). These penalties apply only if no death or serious bodily injury results from the use of such
unlawfully trafficked substance. If such health consequences occur, however, the authorized penalty is a mandatory
minimum sentence of 20 years and up to life in prison. Id.
154
Id. If death or serious bodily injury results from the use of such substance that has been trafficked by a repeat
offender, the authorized penalty is a mandatory minimum sentence of life in prison. Id.
155 Id. § 841(c); (e)-(f).
156 Id. §§ 842, 843.
157 Id. § 843.
158 Id. § 842(a)(2). As noted above, registrations specify the extent to which the DEA has authorized registrants to
manufacture, possess, distribute, or dispense controlled substances. Thus, for example, a pharmacist is authorized to
dispense controlled substances to individuals only pursuant to a valid prescription issued by a DEA-licensed
practitioner and may not dispense such substances without that prescription.
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furnish such records when required to do so by law enforcement officials159 (such as the
requirement that registrants report to the DEA any “suspicious orders of controlled
substances).”160 It is unlawful for registrants to prohibit law enforcement officials from entering
their premises for inspections authorized by the CSA.161 Similarly, practitioners and pharmacists
may not dispense or distribute a controlled substance drug in violation of the CSA’s statutory
prescription requirements.162
The CSA also proscribes certain acts committed by a registrant related to the manufacture and
distribution of controlled substances and listed chemicals. Registrants may not knowingly or
intentionally (1) distribute Schedule I and II substances without a valid order form;163 (2) use an
invalid registration number during the course of handling or acquiring controlled substances;164
(3) furnish false or fraudulent material information in a record or report required by the act;165 or
(4) present false or fraudulent identification when receiving a listed chemical.166 Registrants who
violate the aforementioned provisions may be subject to injunctive or declarative actions filed by
the Attorney General in federal district court in addition to the general penalties described in the
next paragraph.167 Manufacturers may also not produce Schedule I or II controlled substances or
specified listed chemicals that are not expressly authorized by their registration or in excess of the
individual production quotas assigned to them by the DEA.168
Registrants who fail to adhere to the CSA’s regulatory requirements or who engage in certain
prohibited acts may face administrative consequences, civil and criminal fines, and even the
possibility of imprisonment.169 The CSA provides that violations of its regulatory requirements
generally do not constitute a crime and that “imposition of a civil penalty ... shall not give rise to
any disability or legal disadvantage based on conviction for a criminal offense,”170 unless the
violation was committed knowingly, in which case the CSA authorizes imprisonment of up to one
or two years.171
State Regulation of Controlled Substances
In addition to federal oversight of controlled substances and registrants who handle them,
Congress has permitted state governments to regulate the use of controlled substances under their
own state controlled substances acts.172 The U.S. Supreme Court has stated that the CSA
159 Id. § 842(a)(5).
160 Id. § 832, as added by P.L. 115-271, § 3292(b).
161 21 U.S.C. § 842(a)(6).
162 Id. § 842(a)(1).
163 Id. § 843(a)(1).
164 Id. § 843(a)(2).
165 Id. § 843(a)(4)(A).
166 Id. § 843(a)(4)(B).
167 Id. § 843(f).
168 Id. §§ 842(b).
169 Id. § 842(c) (providing penalties for committing prohibited acts set forth in id. § 842(a)); Id. § 843(d) (penalties for
committing prohibited acts set forth in id. § 843(a)).
170 Id. § 842(c)(3).
171 Id. § 842(c)(2).
172 Id. § 903 (“No provision of this title shall be construed as indicating an intent on the part of the Congress to occupy
the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same
subject matter which would otherwise be within the authority of the State.... ”).
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“manifests no intent to regulate the practice of medicine generally” and has observed that its
“structure and operation ... presume and rely upon a functioning medical profession regulated
under the States’ police powers”173 that may be used “to protect the health, safety and welfare of
their citizens.”174 For example, all states have prescription drug monitoring programs (PDMPs)
that maintain statewide electronic databases of prescription controlled substances dispensed to
patients within their jurisdictions; such information may be used by those working in law
enforcement, professional licensing bodies, and health care to identify patterns of prescribing,
dispensing, or receiving controlled substances that could indicate abuse or diversion.175 States
may also subject certain controlled substance medications to stricter regulation than the CSA
requires. For example, the states of Oregon176 and Mississippi177 have passed laws that require
anyone to obtain a prescription for drugs containing pseudoephedrine (a nasal decongestant
commonly found in over-the-counter cold, allergy, and sinus medications), which is an important
ingredient in producing illicit methamphetamine,178 whereas the substance is regulated as a listed
chemical under the CSA that does not require a prescription to dispense.179
The operation of several provisions of the CSA depends on state laws and state regulatory bodies.
For example, if a physician wants to obtain a DEA registration to dispense controlled substance
medications, he must first be “authorized to dispense ... controlled substances under the laws of
the State in which he practices.”180 In addition, the DEA Administrator must be satisfied that
issuing the applicant a registration would be “[]consistent with the public interest,” a
determination that requires the DEA Administrator to consider several statutory factors, including
the “recommendation of the appropriate State licensing board or professional disciplinary
authority”; the applicant’s previous convictions for federal or state controlled substances
offenses; and the applicant’s “[c]ompliance with applicable State, Federal, or local laws relating
to controlled substances.”181 Despite the latitude that Congress has given to states to regulate
controlled substances, however, the CSA nevertheless generally preempts, or overrides, state laws
regarding controlled substances when “there is a positive conflict between” a CSA provision and
“that State law so that the two cannot consistently stand together.”182
DEA’s Legal Authorities for Enforcing the CSA
The DEA’s Office of Diversion Control is responsible for preventing, detecting, and investigating
violations of the CSA involving controlled pharmaceuticals183 while also “ensuring an adequate
173 Gonzales v. Oregon, 546 U.S. 243, 270 (2006).
174 Gonzales v. Raich, 545 U.S. 1, 66 (2005) (O’Connor, J., dissenting).
175 For more information about PDMPs, see CRS Report R42593, Prescription Drug Monitoring Programs, by (name re
dacted), (name redacted), and (name redacted) .
176 Or. Rev. Stat. Ann. § 475.973 (2018) (scheduling pseudoephedrine as a Schedule III substance under Oregon law).
177 Miss. Code Ann. § 41-29-117(d) (2017) (scheduling pseudoephedrine as a Schedule III substance under Mississippi
law).
178 Drug Enf’t Admin., Implementation of the Methamphetamine Production Prevention Act of 2008, 76 Fed. Reg.
74,696 (Dec. 1, 2011).
179 21 U.S.C. § 830.
180 Id. § 823(f).
181 Id.
182 Id. § 903.
183 Id. §§ 878(a), 880.
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and uninterrupted supply for legitimate medical, commercial, and scientific needs.”184 The Office
of Diversion Control also manages the regulation of registrants, promulgates regulations
concerning the handling of controlled substances, and establishes controlled substance production
quotas.185 The Assistant Attorney General for the DOJ’s Criminal Division conducts, handles, or
supervises all criminal and civil litigation to enforce the CSA.186 Several federal courts have held
that the CSA does not contain an express or implied cause of action provision under which private
parties or state,187 local, or tribal governments may sue registrants for noncompliance with their
CSA obligations,188 noting instead that the CSA expressly authorizes only the Attorney General
and the U.S. Department of Justice to enforce federal controlled substances laws.189
Investigations
The DEA can conduct a variety of investigations to monitor and ensure registrant compliance
with the CSA and its implementing regulations.190 As mentioned earlier, registrants may not
prevent law enforcement officials from entering their premises for any inspections authorized by
the CSA.191 The three types of investigations that the DEA may undertake can be classified as
regulatory, complaint, and criminal.192 Regulatory investigations can include scheduled
inspections of registrants, usually every two, three, or five years, although such inspections
generally are directed at manufacturers, wholesale distributors, and importers/exporters rather
than physicians and pharmacies (who receive such oversight from state regulators).193 The DEA
184 Drug Enf’t Admin., DEA Programs: Diversion Control / Prescription Drug Abuse, https://www.dea.gov/ops/
diversion.shtml (last visited Mar. 26, 2018).
185 U.S. GOV’T ACCOUNTABILITY OFF., GAO-15-471, MORE DEA INFORMATION ABOUT REGISTRANTS’ CONTROLLED
SUBSTANCES ROLES COULD IMPROVE THEIR UNDERSTANDING AND HELP ENSURE ACCESS 10 (2015).
186 28 C.F.R. § 0.55(c).
187 The CSA does, however, include a limited provision authorizing a state to bring a civil action in federal court on
behalf of its residents to enforce CSA provisions relating to internet pharmacies and unlawful dispensing of controlled
substances by means of the internet. 21 U.S.C. § 882(c).
188 See, e.g., McKesson Corp. v. Hembree, No. 17-CV-323-TCK-FHM, 2018 WL 340042, at *5 (N.D. Okla. Jan. 9,
2018) (“The CSA does not provide a private right of action. Instead, it delegates the power of enforcement of federal
drug policy to the federal government.”) (citations omitted); Smith v. Hickenlooper, 164 F. Supp. 3d 1286, 1292 (D.
Colo. 2016), aff’d sub nom. Safe Streets All. v. Hickenlooper, 859 F.3d 865 (10th Cir. 2017) (“[T]here is nothing in the
CSA which expressly permits private enforcement of the Act’s provisions. I also find ... that the CSA implicitly
precludes private enforcement, and that Plaintiffs may not, by invoking the court’s equitable powers, circumvent
Congress’s exclusion of private enforcement.”) (quotations and citations omitted); Shmatko v. Arizona CVS Stores
LLC, No. CV-14-01076-PHX-DGC, 2014 WL 3809092, at *2 (D. Ariz. Aug. 1, 2014) (“Federal law unequivocally
holds ... that the ... CSA do[es] not create private rights of action that can give rise to a federal question.”); Schneller ex
rel. Schneller v. Crozer Chester Med. Ctr., 387 F. App’x 289, 293 (3d Cir. 2010) (“The Comprehensive Drug Abuse
Prevention and Control Act is a statute enforceable only by the Attorney General and, by delegation, the Department of
Justice.”); Bowling v. Haas, No. CIV.A. 3:07-032-KKC, 2010 WL 3825467, at *3 (E.D. Ky. Sept. 23, 2010)
([“[C]ourts have uniformly held that the right to enforce the provisions of the CSA ... is possessed exclusively by the
Attorney General ... and that no right of action, either expressed or implied, exists in favor of a private litigant.”); Ringo
v. Lombardi, No. 09-4095-CV-C-NKL, 2010 WL 3310240, at *2 (W.D. Mo. Aug. 19, 2010) (“Consideration of the
text of the CSA in its entirety indicates that Congress did not expressly provide a private right of action and did not
intend to imply a private right of action.”).
189 21 U.S.C. §§ 871(a), (b); 883.
190 Id. § 822(f); 21 C.F.R. § 1301.31.
191 21 U.S.C. § 842(a)(6).
192 See U.S. GOV’T ACCOUNTABILITY OFF., GAO-15-471, MORE DEA INFORMATION ABOUT REGISTRANTS’ CONTROLLED
SUBSTANCES ROLES COULD IMPROVE THEIR UNDERSTANDING AND HELP ENSURE ACCESS 11-12 (2015).
193 Id.
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may initiate complaint investigations after it has received a tip about potential diversion by the
registrant or if the DEA has identified any unusual drug transactions involving the registrant.194
Finally, the DEA may conduct criminal investigations regarding potential criminal activities
involving diversion of controlled substances.195 Criminal investigations can be directed at either
registrants or nonregistrants, such as an individual suspected of stealing drugs from a pharmacy
or one who is trafficking in unlawfully obtained controlled substances.196 Following an
investigation of a registrant that reveals violations of the CSA and its implementing regulations,
the DEA can take certain enforcement actions, as discussed in the following section.
Enforcement Actions
The DEA has discretion197 to initiate enforcement actions to seek a variety of administrative,
civil, and criminal penalties against a registrant who is not in compliance with the CSA,
depending on the severity of the offense and taking into consideration factors such as whether the
registrant has previously violated a CSA regulatory requirement.198 This section focuses on the
administrative actions that the DEA may take against a registrant or an applicant for registration.
Letter of Admonition or Informal Hearing
A noncompliant registrant could face several types of corrective actions. For example, the DEA
can issue a warning letter referred to as a Letter of Admonition (LOA) to a registrant suspected of
conduct inconsistent with his obligations under the CSA and its implementing regulations.199 The
DEA can also hold an Informal Hearing (IH) concerning the registrant; either administrative
action “provide[s] registrants an opportunity to recognize and acknowledge their infractions, and
immediately correct them.”200
Administrative Proceedings to Deny, Revoke, or Suspend a Registration
The DEA Administrator has the authority to deny, revoke, or suspend registrations under certain
circumstances.201 However, before the DEA Administrator can take such an action, the agency
must generally provide the applicant or registrant with notice and an opportunity to demonstrate
why the registration should not be denied, revoked, or suspended.202 This notice is referred to as
194 Id. at 12.
195 Id.
196 Id.
197 See Improving Predictability and Transparency in DEA and FDA Regulation: Hearing Before the H. Comm. on
Energy & Commerce, Subcomm. on Health, 113th Congress 6 (2014) (statement of Joseph T. Rannazzisi, DEA) (“The
decision to take administrative, civil, and/or criminal action against a DEA registrant rests with the DEA and the
prosecuting U.S. Attorneys.”).
198 U.S. GOV’T ACCOUNTABILITY OFF., GAO-15-471, MORE DEA INFORMATION ABOUT REGISTRANTS’ CONTROLLED
SUBSTANCES ROLES COULD IMPROVE THEIR UNDERSTANDING AND HELP ENSURE ACCESS 12-13 (2015)
199 Improving Predictability and Transparency in DEA and FDA Regulation: Hearing Before the H. Comm. on Energy
& Commerce, Subcomm. on Health, 113th Congress 6 (2014) (statement of Joseph T. Rannazzisi, DEA).
200 Id.
201 21 U.S.C. § 824(a).
202 Id. § 824(c). 21 U.S.C. § 824(a) states in pertinent part: “A registration pursuant to section 823 of this title to
manufacture, distribute, or dispense a controlled substance or a list I chemical may be suspended or revoked by the
[Administrator] upon a finding that the registrant—
(1) has materially falsified any application filed pursuant to or required by this subchapter or subchapter II of this
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an Order to Show Cause or OTSC.203 Such an order provides the basis for the proposed denial,
revocation, or suspension (including an identification of the laws or regulations that the applicant
or registrant is alleged to have violated)204 and also notifies the applicant or registrant of the
opportunity to submit to the DEA a corrective action plan (CAP).205 The OTSC instructs the
applicant or registrant to appear at a hearing before a DEA Administrative Law Judge (ALJ) that
must be conducted in accordance with the Administrative Procedure Act (APA).206 If the
registrant submits a CAP, the DEA Administrator is required to determine “whether denial,
revocation, or suspension proceedings should be discontinued.”207
After examining the evidence and arguments submitted by the parties, the ALJ is required to
submit a report to the DEA Administrator that explains his recommended ruling, findings of fact,
conclusions of law, and decision regarding the proposed denial, revocation, or suspension.208 “As
soon as practicable after” receiving the ALJ’s record and report,209 the DEA Administrator is
required to publish in the Federal Register a final order in the proceeding that adopts, modifies,
or rejects the ALJ’s recommended decision.210 The CSA also provides that if the DEA
Administrator suspends or revokes an existing registration, all controlled substances owned or
possessed by the registrant may “be placed under seal ... until the time for taking an appeal has
elapsed or until all appeals have been concluded.... ”211 Once a revocation order becomes final
chapter;
(2) has been convicted of a felony under this subchapter or subchapter II of this chapter or any other law of the
United States, or of any State, relating to any substance defined in this subchapter as a controlled substance or a
list I chemical;
(3) has had his State license or registration suspended, revoked, or denied by competent State authority and is no
longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances
or list I chemicals or has had the suspension, revocation, or denial recommended by competent State authority;
(4) has committed such acts as would render his registration under section 823 of this title inconsistent with the
public interest as determined under such section; or
(5) has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a—
7(a) of [the Social Security Act, which excludes certain individuals and entities from participation in Medicare and
State healthcare programs].... ”
203 Id. § 824(c)(1).
204 Id. § 824(c)(2)(A); 21 C.F.R. § 1301.37(c).
205 21 U.S.C. § 824(c)(2)(C). Generally, a CAP is a document that describes corrective actions that the registrant or
applicant has taken or proposes to take to address any CSA compliance issues identified by the DEA in the OTSC.
Oversight of the Ensuring Patient Access and Effective Drug Enforcement Act: Hearing Before the S. Judiciary Comm.,
115th Cong. 7-8 (2017) (statement of Demetra Ashley, DEA).
206 21 U.S.C. § 824(c)(4) (requiring that the proceedings be conducted in accordance with “subchapter II of chapter 5 of
title 5, United States Code”). The standard of proof used in these administrative proceedings is “preponderance of the
evidence.” See, e.g., Sea Island Broad. Corp. v. FCC, 627 F.2d 240, 243 (D.C. Cir. 1980) (“The use of the
‘preponderance of evidence’ standard is the traditional standard in civil and administrative proceedings. It is the one
contemplated by the APA, 5 U. S. C. § 556 (d).”); Collins Sec. Corp. v. SEC, 562 F.2d 820, 823 (D.C. Cir. 1977) (“The
traditional standard of proof in a civil or administrative proceeding is the preponderance standard.... ”).
207
21 U.S.C. § 824(c)(3).
208 21 C.F.R. § 1316.65.
209 Id. § 1316.67.
210 John J. Mulrooney, II & Andrew J. Hull, Drug Diversion Administrative Revocation and Application Hearings for
Medical and Pharmacy Practitioners: A Primer for Navigating Murky, Drug-Infested Waters, 78 ALB. L. REV. 327,
394 (2014/2015). In issuing this final order, the DEA Administrator should consider the ALJ’s recommended decision
and factual findings, see Morall v. DEA, 412 F.3d 165, 179 (D.C. Cir. 2005) (explaining that although the “DEA is the
ultimate fact finder, the agency’s decision is vulnerable when it does not take the ALJ’s findings into consideration.”).
211 21 U.S.C. § 824(f).
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(meaning all judicial appeals have been exhausted), these controlled substances “shall be forfeited
to the United States” and “[a]ll right, title, and interest in such controlled substances ... shall vest
in the United States.... ”212
Immediate Suspension Orders
Simultaneously with the institution of administrative proceedings to revoke or suspend a
registration (or at any time after the DEA Administrator issues an OTSC notifying the registrant
that the DEA is taking action to revoke or suspend a registration),213 the DEA Administrator may
exercise emergency power to suspend immediately any existing registration for a limited time
period in order to avoid “an imminent danger to the public health or safety.”214 This agency action
is often referred to as an “immediate suspension order” (ISO), and does not require the DEA to
provide the registrant with prior notice or a formal hearing.215 The CSA specifies that the
suspension “shall continue in effect until the conclusion of [the] proceedings [to revoke or
suspend the registration on a final basis], including judicial review thereof, unless sooner
withdrawn by the Attorney General or dissolved by a court of competent jurisdiction.”216
Prior to the enactment into law of the Ensuring Patient Access and Effective Drug Enforcement
Act (EPAEDEA) of 2016,217 the CSA did not expressly define the phrase “imminent danger to the
public health or safety,” and, as a result, courts held that the DEA Administrator possessed
“significant discretion” to determine when the continued registration of a registrant constituted
such a threat.218 As an example of the latitude that courts afforded the DEA Administrator’s
212 Id. See also 21 C.F.R. § 1301.36(f) (“[U]pon service of the order of the Administrator revoking or suspending
registration, the registrant shall, as instructed by the Administrator: (1) Deliver all controlled substances in his/her
possession to the nearest office of the Administration or to authorized agents of the Administration; or (2) Place all
controlled substances in his/her possession under seal ... ”).
213 Id. § 1301.36(e).
214 21 U.S.C. § 824(d)(1).
215 Id. § 824(d).
216 Id. § 824(d)(1).
217 Ensuring Patient Access and Effective Drug Enforcement Act of 2016, P.L. 114-145, 130 Stat. 353 (codified at 21
U.S.C. §§ 823, 824).
218 In re Burka, 684 F. Supp. 1300, 1305 (E.D. Pa. 1988) (stating that “Congress has granted the DEA Administrator
significant discretion in making the preliminary determination of whether a registration should be temporarily
suspended.... ”); see also Holiday CVS, LLC v. Holder, 839 F. Supp. 2d 145, 164 (D.D.C. 2012), vacated as moot, 493
F. App’x 108 (D.C. Cir. 2012) (noting that “the CSA vests the Administrator with the authority to” determine whether
imminent danger exists); Cardinal Health, Inc. v. Holder, 846 F. Supp. 2d 203, 225 (D.D.C. 2012) (“Far from providing
‘precise guidelines’ that restrict the meaning of ‘imminent danger,’ the Act vests the Administrator with discretion to
make such a determination. In addition, the statute contemplates that an ISO will be issued in emergency
circumstances, prior to an administrative hearing or the development of a formal evidentiary record. Thus, given the
degree of discretion vested with the Administrator as well as the summary and urgent nature of an ISO, the Court’s
review ‘must be correspondingly relaxed.’”) (citation omitted). However, in at least two cases prior to enactment of the
2016 EPAEDEA, courts did reject DEA’s ISO determination that the alleged violations met the “imminent danger”
standard. See, e.g., Bates Drug Stores v. Holder, Case No. CV–11–0167–EFS, 2011 WL 1750066 *3 (E.D. Wash.
2011) (“[T]he Court has serious doubts that the alleged violations ... pose an imminent danger to public health and
safety. There is nothing in the record indicating that any Bates patient has been harmed or injured by the alleged
violations. Nor is there any evidence that any controlled substance was dispensed to an improper individual, for an
improper purpose, or in an improper dosage.... On this record, the Court finds that serious questions exist as to whether
the Suspension Order supports a finding that Bates’ practices posed an imminent danger to the public health and
safety.”); see also Norman Bridge Drug Co. v. Banner, 529 F.2d 822, 826, 829 (5 th Cir. 1976) (holding that the lower
court’s decision that there was no imminent danger to the public health and safety was not clearly erroneous due to,
among other things, the DEA being aware of the facts alleged to justify issuance of the ISO for seven months prior to
issuing the order).
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imminent danger finding, a federal district court permitted the DEA to rely on pharmacy
controlled substances sales data from 2008 to support an ISO issued in early 2012.219
The EPAEDEA amended the CSA to provide, for the first time, a statutory definition of the
phrase “imminent danger to the public health or safety,” which limits the DEA Administrator’s
discretion to issue an ISO and creates new evidentiary requirements that he must satisfy before
issuing such an order.220 Under the EPAEDEA, the DEA’s authority to issue an ISO depends on
the agency’s ability to prove two things: (1) “an immediate threat that death, serious bodily harm,
or abuse of a controlled substance will occur” due to the failure of the registrant to comply with
the CSA’s requirements, including those obligating the registrant “to maintain effective controls
against diversion,”221 and (2) the probability that such a threat will occur without an immediate
suspension of a registration, which the statute requires to be a “substantial likelihood.”222 Some
have suggested that the legislative changes made by the EPAEDEA considerably weaken the
power of the DEA to issue an ISO against a distributor or manufacturer,223 although others have
argued that the addition of a statutory definition of “imminent danger to the public health or
safety” was necessary in order to prevent “a completely subjective determination made solely by
the DEA” that “summarily eliminate[s] the registrant’s ability to handle controlled substances
before any due process hearing.”224
In response to the ISO, a registrant could seek immediate judicial review of the ISO in federal
court,225 arguing that the DEA acted arbitrarily and capriciously226 in violation of the APA.227
However, a registrant faces a difficult burden in convincing a court to enjoin the DEA’s
enforcement of the ISO pending resolution of the revocation or suspension proceedings.228 In
219 Holiday CVS, 839 F. Supp. 2d at 164 (stating that “the DEA could reasonably rely on sales trends from past years to
show a pattern of inadequate anti-diversion efforts, which ultimately culminated in the need for immediate suspension
in February 2012.”).
220 P.L. 114-145, 130 Stat. 354 (codified at 21 U.S.C. § 824(d)(2)).
221 21 U.S.C. § 824(d)(2).
222 Id.
223 See John J. Mulrooney, II & Katherine E. Legal, Current Navigation Points in Drug Diversion Law: Hidden Rocks
in Shallow, Murky, Drug-Infested Waters, 101 MARQ. L. REV. 333, 347 (Winter 2017) (“If it had been the intent of
Congress to completely eliminate the DEA’s ability to ever impose an immediate suspension on distributors or
manufacturers, it would be difficult to conceive of a more effective vehicle for achieving that goal.”); see also Scott
Higham & Lenny Bernstein, The Drug Industry’s Triumph Over the DEA, WASH. POST, Oct. 15, 2017, at A01 (“In
April 2016, at the height of the deadliest drug epidemic in U.S. history, Congress effectively stripped the Drug
Enforcement Administration of its most potent weapon against large drug companies suspected of spilling prescription
narcotics onto the nation’s streets.”).
224 Oversight of the Ensuring Patient Access and Effective Drug Enforcement Act: Hearing Before the S. Judiciary
Comm., 115th Cong. 6 (2017) (statement of John M. Gray, Healthcare Distribution Alliance). According to a supporter
of the EPAEDEA, such an immediate prohibition on the legal right of the registrant to handle controlled substances as a
result of an ISO could “limit access to needed medications by legitimate patients.” Id.
225 21 U.S.C. § 877 provides that “any person aggrieved by a final decision of the Attorney General may obtain review
of the decision in the United States Court of Appeals for the District of Columbia or for the circuit in which his
principal place of business is located upon petition filed with the court and delivered to the Attorney General within
thirty days after notice of the decision.”
226 See Holiday CVS, 839 F. Supp. 2d at 158 (“As courts in this Circuit and elsewhere have recognized, the arbitrary
and capricious standard of review applies to APA claims challenging the issuance of an ISO under 21 U.S.C. §
824(d).”).
227 5 U.S.C. § 706(2).
228 Id. (“The reviewing court shall—hold unlawful and set aside agency action, findings, and conclusions found to be—
arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law ... [or] unsupported by substantial
evidence.... ”).
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order to obtain such preliminary injunctive relief,229 a registrant “must establish that he is likely to
succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary
relief, that the balance of equities tips in his favor, and that an injunction is in the public
interest.”230 The CSA provides that a reviewing court must use a “substantial evidence” standard
in considering the DEA’s findings of facts with respect to an ISO,231 though a court applies the
APA’s arbitrary and capricious standard of review when considering the DEA’s reason for
deciding to adopt, modify, or reject the ALJ’s recommendation concerning an ISO.232 A federal
appellate court has explained its review of the DEA’s issuance of an ISO under the APA as
follows: “To uphold DEA’s decision, ... we must satisfy ourselves that the agency examined the
relevant data and articulated a satisfactory explanation for its action including a rational
connection between the facts found and the choice made.”233
A registrant served with an ISO could also request “an expedited administrative hearing”234
before an ALJ on the merits of the revocation or suspension at a time before that indicated in the
OTSC.235 DEA regulations specify that the DEA Administrator “shall” grant the request for an
earlier hearing and “fix a date for such hearing as early as reasonably possible.”236
DEA’s Response to the Opioid Abuse Crisis
This section describes selected DEA actions intended to help alleviate the opioid crisis.
DEA Actions Against Registrants
As discussed earlier in this report, the CSA provides the DEA with a variety of criminal, civil, and
administrative tools to hold manufacturers, distributors, pharmacies, and physicians accountable
for actions that violate the CSA’s regulatory requirements. The DEA has used these authorities in
229 A preliminary injunction is “’an extraordinary and drastic remedy, one that should not be granted unless the movant,
by a clear showing, carries the burden of persuasion.’” Mazurek v. Armstrong, 520 U.S. 968, 972 (1997) (per
curiam)(citation omitted).
230 See Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7, 20 (2008).
231 21 U.S.C. § 877 (“Findings of fact by the Attorney General, if supported by substantial evidence, shall be
conclusive.”). According to the Supreme Court, substantial evidence “means evidence which is substantial, that is,
affording a substantial basis of fact from which the fact in issue can be reasonably inferred. Substantial evidence is
more than a scintilla, and must do more than create a suspicion of the existence of the fact to be established.” NLRB v.
Columbian Enameling & Stamping Co., 306 U.S. 292, 299-300 (1939) (citations omitted); see also Brainard v. Sec’y
of Health & Hum. Servs., 889 F.2d 679, 681 (6th Cir. 1989) (“Substantial evidence is more than a scintilla of evidence
but less than a preponderance.... ”).
232 See Morall v. DEA, 412 F.3d 165, 177 (D.C. Cir. 2005) (“Although 21 U.S.C. § 877 does not specify a standard for
reviewing the agency’s reasoning as distinguished from its factfinding, the APA provides the appropriate default
standard: A court must set aside agency action it finds to be arbitrary, capricious, an abuse of discretion, or otherwise
not in accordance with law.... An agency [decision is] arbitrary and capricious if the agency ... entirely failed to
consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence
before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency
expertise,”) (internal quotations and citations omitted); see also MacKay v. DEA, 664 F.3d 808, 817 (10th Cir. 2011)
(“Under the Administrative Procedure Act, we may set aside the Deputy Administrator’s decision only if it is arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law ... [or] unsupported by substantial
evidence.... ”) (internal quotations and citations omitted).
233 Morall, 412 F.3d at 177 (internal quotations and citations omitted).
234 See, e.g, Novelty Distribs. v. Leonhart, 562 F. Supp. 2d 20, 23 (D.D.C. 2008).
235 21 C.F.R. § 1301.36(h).
236 Id.
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connection with the opioid crisis. For example, in February and March 2018, the DEA “surged its
enforcement and administrative resources” to target prescribers and pharmacies suspected of
diverting large amounts of opioid drugs, resulting in 147 revoked registrations and 28 arrests.237
In addition, in July 2017, CVS Pharmacy Inc. agreed to a $5 million settlement payment as well
as an administrative compliance plan with the DEA, to resolve the federal government’s
allegations that nine of its pharmacies in the Eastern District of California had failed to keep and
maintain accurate records of its controlled substances, in violation of the CSA’s recordkeeping
requirements.238 In early 2016, CVS also paid $8 million to the United States to settle allegations
that certain CVS pharmacies in Maryland had dispensed controlled substances, including the
opioids oxycodone, fentanyl, and hydrocodone, in violation of the CSA by failing to comply with
their duty to ensure that the prescriptions were issued for legitimate medical purposes.239 In 2013,
Walgreens agreed to pay $80 million in civil penalties to resolve DEA administrative actions and
civil penalty investigations concerning “an unprecedented number of record-keeping and
dispensing violations” occurring at six Walgreens pharmacies and a Walgreens drug distribution
center in Florida that allegedly resulted in oxycodone and other prescription opioids to be
diverted.240 As part of this settlement, Walgreens agreed to several terms and conditions,
including ending its practice of “compensat[ing] its pharmacists based on the volume of
prescriptions filled.”241
The DEA has also focused its attention on wholesale distributors of prescription opioids, which
ship the drugs from drug manufacturers to pharmacies, and their compliance with the CSA’s
recordkeeping and reporting requirements.242 Several DEA investigations into these wholesale
distributers resulted in civil penalty settlements. In January 2017, one of the largest U.S. drug
distributors, McKesson Corporation, agreed to pay a $150 million civil payment to resolve DEA
allegations that it had, in violation of CSA regulatory requirements, “failed to design and
implement an effective system to detect and report ‘suspicious orders’ for controlled substances
distributed to its independent and small chain pharmacy customers.”243 The federal government
alleged that “[f]rom 2008 until 2013, McKesson supplied various U.S. pharmacies an increasing
amount of oxycodone and hydrocodone pills, frequently misused products that are part of the
237 Press Release, U.S. Dep’t of Just., Off. of Pub. Aff., DEA Surge in Drug Diversion Investigations Leads to 28
Arrests and 147 Revoked Registrations (Apr. 2, 2018), https://www.justice.gov/opa/pr/dea-surge-drug-diversioninvestigations-leads-28-arrests-and-147-revoked-registrations.
238 Press Release, U.S. Dep’t of Just., U.S. Att’y Off., Dist. of Md., CVS Pharmacy Inc. Pays $5M to Settle Alleged
Violations of the Controlled Substance Act (July 11, 2017), https://www.justice.gov/usao-edca/pr/cvs-pharmacy-incpays-5m-settle-alleged-violations-controlled-substance-act.
239 Press Release, U.S. Dep’t of Just., U.S. Att’y Off., Dist. of Md., United States Reaches $8 Million Settlement
Agreement with CVS for Unlawful Distribution of Controlled Substances (Feb. 12, 2016), https://www.justice.gov/
usao-md/pr/united-states-reaches-8-million-settlement-agreement-cvs-unlawful-distribution-controlled.
240 Press Release, U.S. Dep’t of Just., U.S. Att’y Off., S.D. of Fla, Walgreens Agrees To Pay A Record Settlement Of
$80 Million For Civil Penalties Under The Controlled Substances Act (June 11, 2013), https://www.justice.gov/usaosdfl/pr/walgreens-agrees-pay-record-settlement-80-million-civil-penalties-under-controlled.
241 Id.
242 See Lenny Bernstein et al., How Drugs Intended for Patients Ended Up in the Hands of Illegal Users: “No One Was
Doing Their Job,” WASH. POST, Oct. 22, 2016, http://wapo.st/2etAUdQ?tid=ss_mail&utm_term=.e09794f54343 (“The
Drug Enforcement Administration targeted these middlemen for a simple reason. If the agency could force the
companies to police their own drug shipments, it could keep millions of pills out of the hands of abusers and dealers.
That would be much more effective than fighting ‘diversion’ of legal painkillers at each drugstore and pain clinic.”).
243 Press Release, U.S. Dep’t of Just., Off. of Pub. Aff., McKesson Agrees to Pay Record $150 Million Settlement for
Failure to Report Suspicious Orders of Pharmaceutical Drugs (Jan. 17, 2017), https://www.justice.gov/opa/pr/
mckesson-agrees-pay-record-150-million-settlement-failure-report-suspicious-orders.
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current opioid epidemic.”244 In addition to the monetary penalty, the settlement requires
McKesson to (1) suspend for several years sales of controlled substances from a number of its
distribution centers, (2) agree to certain “enhanced compliance obligations” that include periodic
auditing and staffing and organization improvements; and (3) accept the oversight of an
independent monitor to assess the company’s adherence with the compliance terms.245
Another major pharmaceutical drug distributor, Cardinal Health, Inc., agreed in December 2016
to pay $44 million to the federal government to settle allegations that it had failed to notify the
DEA when it filled unusually large and frequent orders for controlled substances requested by
pharmacies located in Maryland, Florida, and New York, and that it had failed to maintain
effective controls against diversion.246 The settlement agreement between Cardinal Health and the
federal government included an admission by the company that “from January 1, 2009 to May 14,
2012, it failed to report suspicious orders to the DEA as required by the CSA.”247
In 2014, the DEA took an administrative action to revoke the registration of Masters
Pharmaceuticals, Inc. (Masters), a bulk supplier of prescription medications to many U.S.
pharmacies, after concluding that the company had not satisfied its legal obligation to monitor
and report to the DEA suspicious orders for controlled substances.248 Masters had previously
entered into a settlement agreement with the DEA in 2009 in which Masters agreed to pay
$500,000 and implement a compliance system to detect suspicious orders of controlled
substances and prevent the substances from being diverted into illegal channels.249 However, in
the years following the settlement, the DEA grew to suspect that Masters’s employees were not
detecting and reporting to the DEA suspicious orders of oxycodone products.250 In 2013, the DEA
issued an Order to Show Cause why Masters’s registration should not be revoked, in light of
allegations that Masters had ignored its duty to report suspicious orders after its computer system
had flagged controlled substance orders that were unusual in size, frequency, or pattern.251 The
DEA Administrator concluded that Masters’s repeated violations of the suspicious orders
reporting requirement warranted revocation of its registration to distribute controlled
substances.252 Masters challenged the DEA’s revocation decision in federal court, arguing among
other things that the DEA’s factual conclusions were not supported by the record.253 In June 2017,
the U.S. Court of Appeals for the D.C. Circuit denied Masters’s petition for review, seeking to
overturn the DEA’s final order, after the court found “no prejudicial error in DEA’s decision.”254
In addition to these actions against distributors, the DEA has also investigated opioid
manufacturers for their failure to report suspicious orders of controlled substances that occurred
downstream in the drug supply chain. In July 2017, the DEA confirmed it had reached a $35
244 Id.
245 Id.
246 Press Release, U.S. Dep’t of Just., U.S. Att’y Off., Dist. of Md., Cardinal Health Agrees to $44 Million Settlement
for Alleged Violations of Controlled Substances Act (Dec. 23, 2016), https://www.justice.gov/usao-md/pr/cardinalhealth-agrees-44-million-settlement-alleged-violations-controlled-substances-act.
247
Id.
248 Masters Pharm., Inc. v. DEA, 861 F.3d 206, 211 (D.C. Cir. 2017).
249 Id. at 213.
250 Id. at 214.
251 Id.
252 Id. at 215
253 Id.
254 Id. at 212.
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million civil penalty settlement with Mallinckrodt LLC, a drug manufacturer that is one of the
largest makers of the highly addictive generic pain reliever oxycodone.255 This settlement
resolved allegations that the company committed several violations of the CSA from 2008 until
2011 by supplying to drug distributors that, in turn, supplied pharmacies and pain clinics, “an
increasingly excessive quantity of oxycodone pills without notifying DEA of these suspicious
orders.”256 The DEA described this settlement as “groundbreaking” in part because it is the first
time the DEA has been able to hold a drug manufacturer responsible for detecting and reporting
suspicious orders relating to downstream sales between its distributor customers and the
distributors’ customers (pharmacies).257 This settlement agreement also apparently contains the
first public statement of the DEA’s position258 that “controlled substance manufacturers need to
go beyond ‘know your customer’ to use otherwise available company data to ‘know your
customer’s customer’ to protect these potentially dangerous pharmaceuticals from getting into the
wrong hands.”259 Under the settlement, Mallinckrodt agreed to analyze data it collects involving
“chargebacks,” which are reimbursements the company offers to their drug distributor customers
based on the distributor’s discounted sale of its drugs to pharmacies and pain clinics, in order to
monitor and report to the DEA any suspicious orders of oxycodone placed by the distributor’s
customers.260 Commentators have argued that the legal basis of the DEA imposing an obligation
on a drug manufacturer to “know your customer’s customer,” and its ability to hold the company
“responsible for what happens to its drugs once the distributors send them to their customers,”261
may be uncertain.262 Moreover, one observer has characterized the DEA’s action as “creat[ing] ...
a new requirement by announcing it in a press release” and has argued instead that such a change
needs to be made in accordance with notice and comment rulemaking requirements under the
255 Press Release, U.S. Dep’t of Just., Off. of Pub. Aff., Mallinckrodt Agrees to Pay Record $35 Million Settlement for
Failure to Report Suspicious Orders of Pharmaceutical Drugs and for Recordkeeping Violations (July 11, 2017),
https://www.justice.gov/opa/pr/mallinckrodt-agrees-pay-record-35-million-settlement-failure-report-suspicious-orders.
[hereinafter Mallinckrodt Settlement].
256 Id.
257 Id.
258 See John A. Gilbert, DEA Announces “Groundbreaking” Guidance that is Inconsistent with the Settlement they are
Announcing – Time at Last for Rulemaking? (July 20, 2017), http://www.fdalawblog.net/2017/07/dea-announcesgroundbreaking-guidance-that-is-inconsistent-with-the-settlement-they-are-announcing-t/ (last accessed Apr. 12, 2018)
(“[W]e could find no prior public statement from DEA that a manufacturer must report such third party transactions as
suspicious under 21 C.F.R. § 1301.74(b).”).
259 Mallinckrodt Settlement, supra note 255. An investigation by the Washington Post reveals that, prior to the
settlement agreement, “the DEA had provided conflicting guidance to Mallinckrodt about its responsibilities to report
suspicious orders” from its customer’s customers. Lenny Bernstein & Scott Higham, The Government’s Struggle to
Hold Opioid Manufacturers Accountable, WASH. POST, Apr. 2, 2017, https://www.washingtonpost.com/graphics/
investigations/dea-mallinckrodt/. For example, a DEA supervisor in St. Louis had informed the company in 2010 “that
it had a responsibility to keep close tabs on its customers, the distributors, as well as the distributor’s customers, the
pharmacies and doctors.” Id. Yet a DEA investigator in New York had informed Mallinckrodt that “no one in her
region, including her supervisor, had heard anything about ‘know your customer’s customer[’]” and noted that “the
regulations do not reflect such a requirement.” Id.
260 Mallinckrodt Settlement, supra note 255.
261 Bernstein & Higham, supra note 259.
262 See, e.g., Brian T. O’Connor & Andrew O’Connor, DOJ Settlement Looks to Set New Benchmarks for Suspicious
Order Monitoring (July 14, 2017), https://www.ropesgray.com/en/newsroom/alerts/2017/07/DOJ-Settlement-Looks-toSet-New-Benchmarks-for-Suspicious-Order-Monitoring (last accessed Apr. 12, 2018) (“The legal basis for those
“requirements” remains uncertain at best, and DOJ’s statements leave open many questions about how far
manufacturers must go to comply with DEA rules.”).
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APA.263 As of the date of this report, the DEA’s position that manufacturers “need to go beyond
‘know your customer’” practices has not been challenged in court.
Emergency Scheduling of Illicit Fentanyl
Fentanyl is a powerful synthetic opioid264 analgesic that mimics the effects of morphine and
heroin, but is 50 to 100 times more potent.265 Pharmaceutically produced fentanyl is a Schedule II
prescription drug that may be used by patients to manage severe pain after surgery, for example,
and can be administered via injection, in lozenges, or transdermal patch.266
Most fentanyl overdoses do not involve prescription fentanyl, but rather nonpharmaceutical
fentanyl that is illicitly produced in clandestine laboratories located abroad, in particular in
Mexico and China.267 A recent investigation by a Senate subcommittee revealed that “many
Americans are purchasing fentanyl and other illicit opioids online and having them shipped here
through the international mail system.”268 Such illicit fentanyl can be mixed with other opioids
such as heroin to increase its effects, and can be sold as a powder or as tablets that are “intended
to mimic the appearance of prescription opioid medications such as oxycodone or
hydrocodone.269 According to the 2018 National Drug Threat Assessment published in October
2018 by the DEA, fentanyl “is a major contributor to the continuing epidemic of drug overdose
deaths” in the United States and “[s]ynthetic opioids are now involved in more deaths than any
other illicit drug.”270 In July 2018, then-Attorney General Sessions announced the formation of
“Operation Synthetic Opioid Surge,” an initiative in which the Justice Department will be
focusing its prosecutorial priorities on “every readily provable case involving the distribution of
fentanyl, fentanyl analogues, and other synthetic opioids, regardless of drug quantity,” within 10
areas of the nation that are experiencing some of the highest drug overdose death rates.271
However, making the problem more difficult for the federal government in stopping illicit
fentanyl traffickers are “[o]verseas chemical manufacturers, aided by illicit domestic distributors,
[who] currently attempt to evade regulatory controls by creating structural variants of fentanyl
that are not directly listed under” the CSA.272 The DEA has stated that fentanyl-related compound
263 Gilbert, supra note 258.
264 For more information about synthetic drugs generally, see CRS Report R42066, Synthetic Drugs: Overview and
Issues for Congress, by (name redacted) and (name redacted)
.
265 NAT’L INST. ON DRUG ABUSE, DRUG FACTS: FENTANYL 1 (June 2016), https://d14rmgtrwzf5a.cloudfront.net/sites/
default/files/fentanyldf_06032016_final.pdf.
266 Id.
267 Drug Enf’t Admin., FAQ’s – Fentanyl and Fentanyl-Related Substances, https://www.dea.gov/druginfo/fentanylfaq.shtml (last visited Apr. 5, 2018).
268 STAFF OF S. COMM. ON HOMELAND SECURITY & GOV’T AFF., PERMANENT SUBCOMM. ON INVESTIGATIONS, 115TH
CONG., COMBATTING THE OPIOID CRISIS: EXPLOITING VULNERABILITIES IN INTERNATIONAL MAIL 2 (2018).
269 Fentanyl: The Next Wave of the Opioid Crisis: Hearing Before the H. Comm. on Energy & Commerce, Subcomm.
on Oversight and Investigations, 115th Cong. 1 (2017) (statement of Kemp Chester, Acting Dir. of Nat’l Drug Control
Pol’y).
270 DRUG ENF’T ADMIN., 2018 NATIONAL DRUG THREAT ASSESSMENT 27 (Oct. 2018).
271 Press Release, U.S. Dep’t of Just., Off. of Pub. Aff., Attorney General Jeff Sessions Announces the Formation of
Operation Synthetic Opioid Surge (S.O.S.) (July 12, 2018), https://www.justice.gov/opa/pr/attorney-general-jeffsessions-announces-formation-operation-synthetic-opioid-surge-sos.
272 Press Release, U.S. Dep’t of Just., Off. of Pub. Aff., Department of Justice Announces Significant Tool in
Prosecuting Opioid Traffickers in Emergency Scheduling of All Fentanyls (Nov. 9, 2017), https://www.justice.gov/opa/
pr/department-justice-announces-significant-tool-prosecuting-opioid-traffickers-emergency.
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“[m]anufacturers and distributors will continue to stay one step ahead of any state or federal drugspecific banning or control action by introducing and repackaging new products that are not listed
as such in any of the controlled substance schedules.”273 Since 2015, DEA has exercised its
emergency scheduling authority eight times to control 17 substances structurally related to
fentanyl by placing them temporarily in Schedule I.274 In February 2018, the DEA issued a
broader temporary scheduling order that attempts to schedule all fentanyl-related substances that
are not otherwise controlled in any schedule, by creating a definition of a new class of substances
that is structurally related to fentanyl by virtue of one or more specified modifications to the
substance’s formulation.275 It remains to be seen whether the DEA’s attempt to schedule
proactively an entire class of illicit fentanyl substances simultaneously, including substances that
have not yet been introduced into the U.S. market by drug traffickers, will be subject to a legal
challenge276 under the APA, claiming the DEA’s action to be inconsistent with its emergency
scheduling authority under the CSA.277
Aggregate Production Quotas for Certain Schedule II Opioids
As discussed previously in this report, the DEA limits the quantity of Schedule I and II controlled
substances (referred to as aggregate production quotas, or APQs) that may be produced in a given
calendar year. According to the Acting Assistant Administrator of the DEA’s Diversion Control
Division, “since 2014, DEA has observed a decline in prescriptions written for certain Schedule II
opioids,” including oxycodone, hydrocodone, fentanyl, and morphine.278 In November 2017, the
DEA responded to the decreased demand for these drugs when it released the 2018 APQs,279
which reduce by nearly 20% (compared to the 2017 levels) the amount of prescription opioids
that can be manufactured in 2018.280 According to a DEA spokesperson, this decrease in APQs
“can be attributed to combined local, state, and federal activities and interventions, including
creating new partnerships, enforcing current regulations, and dissemination of provider education
and guidance documents.... ”281 Several organizations representing hospitals, anesthesiologists,
and pharmacists have raised their concerns to the DEA that the new APQs could exacerbate the
problem they are experiencing with “critical shortages” of injectable opioid medications,
273 Fentanyl: The Next Wave of the Opioid Crisis: Hearing Before the H. Comm. on Energy & Commerce, Subcomm.
on Oversight and Investigations, 115th Cong. 3 (2017) (statement of Louis Milione, DEA).
274 Drug Enf’t Admin., Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in
Schedule I, 83 Fed. Reg. 5,188, 5,189 (Feb. 6, 2018).
275 Id. at 5189.
276 See John A. Gilbert & Larry K. Houck, DEA Proposes a New Strategy to Ban Illicit Fentanyl-Related Substances
(Jan. 19, 2018), http://www.fdalawblog.net/2018/01/dea-proposes-a-new-strategy-to-ban-illicit-fentanyl-relatedsubstances/ (last visited Apr. 12, 2018) (questioning whether DEA’s attempt to temporarily schedule fentanyl-related
products by broadly defining a class of products based on a definition of their potential formulation “can withstand the
expected challenges from defense attorneys related to whether this type of scheduling is consistent with the CSA.”).
277 5 U.S.C. § 706 (“The reviewing court court shall – (2) hold unlawful and set aside agency action ... found to be –
(A) ... not in accordance with law”).
278 Oversight of the Ensuring Patient Access and Effective Drug Enforcement Act: Hearing Before the S. Judiciary
Comm., 115th Cong. 4 (2017) (statement of Demetra Ashley, DEA).
279 Drug Enf’t Admin., Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances and
Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for
2017, 82 Fed. Reg. 51,293 (Nov. 3, 2017).
280 Oversight of the Ensuring Patient Access and Effective Drug Enforcement Act: Hearing Before the S. Judiciary
Comm., 115th Cong. 4 (2017) (statement of Demetra Ashley, DEA).
281 Id.
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including morphine, fentanyl, and hydromorphone, which are used to treat the pain needs of
patients undergoing interventional procedures (such as colonoscopy or cardiac catheterization)
and surgeries.282 These organizations suggest that the DEA “temporarily reallocate or revise APQ
to allow other manufacturers to supply product until the shortages resolve,” and also note that
their request is “specific to these injectable medications and does not extend to other dosage
forms or opioid products.”283
In August 2018, the DEA released proposed APQs for 2019 that would require further reductions
in the quantity of Schedule II opioids that may be manufactured in the United States in 2019.284
The proposed 2019 APQ for Schedule I and II controlled substances “decreases manufacturing
quotas for the most six frequently misused opioids for 2019 by an average ten percent as
compared to the 2018 amount,” including oxycodone, hydrocodone, oxymorphone,
hydromorphone, morphine, and fentanyl.285
Congressional Actions Addressing the Opioid
Epidemic
Existing legal authorities supplied DEA with the tools for the agency’s efforts to combat opioid
abuse as described in the previous section. In recent years, Congress has also taken action to
address perceived deficiencies in the federal regulatory regime governing opioids. To date, the
most comprehensive legislative response to the overprescribing and abuse of opioids is the
Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients
and Communities Act (P.L. 115-271) (the SUPPORT for Patients and Communities Act, or the
SUPPORT Act) that President Trump signed into law on October 24, 2018. Title III, subtitle B of
the SUPPORT Act contains provisions that amend the CSA in various ways to address the opioid
epidemic, as described in the following sections.286
Expanding Disposal Options for Unwanted Opioid Medication
Young adults and teenagers who seek to abuse prescription opioids may find access to expired or
unwanted controlled substance medication from their parents’ medicine cabinets287 or even the
trash.288 One approach to addressing the prescription opioid abuse problem is to reduce the
282 Letter from Am. Hosp. Ass’n, et al., to Robert W. Patterson, Acting Admin., DEA (Feb. 27, 2018),
https://www.aha.org/system/files/2018-02/180227-joint-letter-to-dea-re-apq-for-iv-opioids.pdf.
283 Id. at 2.
284 Drug Enf’t Admin., Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and
Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for
2019, 83 Fed. Reg. 42,164 (Aug. 20, 2018).
285 Press Release, U.S. Dep’t of Just., Off. of Pub. Aff., Justice Department, DEA Propose Significant Opioid
Manufacturing Reduction in 2019 (Aug. 16, 2018), https://www.justice.gov/opa/pr/justice-department-dea-proposesignificant-opioid-manufacturing-reduction-2019.
286 For a more thorough discussion and analysis of these changes and of other provisions of the SUPPORT Act, see
CRS Report R45405, The SUPPORT for Patients and Communities Act (P.L. 115-271): Food and Drug Administration
and Controlled Substance Provisions, coordinated by (name redacted) ; and CRS Report R45423, Public Health and
Other Related Provisions in P.L 115-271, the SUPPORT for Patients and Communities Act, coordinated by (name reda
cted) and (name redacted)
.
287 See 155 CONG. REC. E386 (daily ed. Feb. 25, 2009) (extension of remarks of Rep. Jay Inslee) (“Family medicine
cabinets all across America have turned into the drug dealers of today.”).
288 Partnership for Drug-Free Kids, Safeguard Against Medicine Abuse: Securing and Disposing Medications,
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availability of such drugs by having patients properly dispose of their unwanted opioid
medications that have accumulated in their homes.289 For example, patients may want to get rid of
their expired or unused drugs by returning them to pharmacies or giving them to their prescribing
physicians. Yet, when Congress originally drafted the CSA, “it did not account for circumstances
in which controlled substances were lawfully dispensed to and possessed by an ultimate user but
not fully used.”290 To make it easier and more convenient for patients to dispose of unwanted
controlled substances, including opioid medications, Congress enacted the Secure and
Responsible Drug Disposal Act of 2010 (Disposal Act).291 The Disposal Act amended the CSA to
allow a patient to deliver controlled substances to an entity that is authorized by federal law to
dispose of them, provided that such disposal occurs in accordance with regulations issued by the
Attorney General to prevent diversion of controlled substances.292 These implementing
regulations, issued by the DEA in September 2014, substantially expand the options and
opportunities available to patients for safe and secure disposal of their unwanted prescription
opioid and other controlled substance medication.293
The DEA regulations governing secure disposal of controlled substances allow three primary
options for patient disposal of controlled substances. The first option is for federal, state, tribal, or
local law enforcement agencies to conduct periodic drug “take-back” events to collect controlled
substances from unwanted users; private entities or community groups may also partner with law
enforcement to hold community take-back events.294 Second, DEA-registered manufacturers,
distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, or retail
pharmacies that wish to become collectors of unwanted controlled substances for disposal
purposes must seek authorization from DEA to do so.295 Authorized collectors may then conduct
“mail-back” programs that utilize the mail system for convenient transfer of the unwanted
controlled substances, although the physical packages in which the drugs are shipped must
comply with certain requirements (for example, tamper-resistance and tracking numbers) that
DEA has specified.296 The third option permits law enforcement agencies or authorized collectors
to manage, maintain, and empty secure collection receptacles at their DEA registered location.297
A long-term care facility may also dispose of controlled substances on behalf of its residents (or
former residents) by using on-site collection receptacles that are installed, managed, and
maintained by authorized retail pharmacies or hospitals/clinics with an on-site pharmacy.298
Finally, the regulations provide requirements that collectors must follow regarding methods of
https://drugfree.org/article/safeguard-against-medicine-abuse-securing-and-disposing-medications/ (last visited Apr. 4,
2018).
289 Press Release, Drug Enf’t Admin. Pub. Aff., Drug Enforcement Administration Collects Record Number of Unused
Pills as Part of its 14th Prescription Drug Take Back Day (Nov. 7, 2017), https://www.dea.gov/divisions/hq/2017/
hq110717.shtml.
290 Drug Enf’t Admin., Disposal of Controlled Substances, 77 Fed. Reg. 75,784, 75,786 (proposed Dec. 21, 2012).
291 P.L. 111-273, 124 Stat. 2858 (codified at 21 U.S.C. § 822).
292 Id.
293 Drug Enf’t Admin., Disposal of Controlled Substances, 79 Fed. Reg. 53,520 (Sept. 9, 2014).
294 Id. at 53,568, adding 21 C.F.R. § 1317.65(a).
295 Id. at 53,567, adding 21 C.F.R. § 1317.40(a).
296 Id. at 53,568, adding 21 C.F.R. § 1317.70(a). Mail-back programs may also be administered by federal, state, tribal,
or local law enforcement.
297 Id., adding 21 C.F.R. § 1317.75(a).
298 Id. at 53,569, adding 21 C.F.R. § 1317.75(d)(2)(iii) and 21 C.F.R. § 1317.80.
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destroying controlled substances and destruction procedures, in order to render the collected
controlled substances “non-retrievable.”299
Congress also enacted prescription drug disposal and take-back provisions as part of the
Comprehensive Addiction and Recovery Act (CARA) of 2016.300 Section 201 of CARA
authorizes the creation of a grant program at the Department of Justice addressing the problems
of opioid addiction and abuse, through which the Attorney General may award grants to states,
units of local governments, and Indian tribes to fund their activities relating to opioid abuse,
including “[d]eveloping, implementing, or expanding a prescription drug take-back program.”301
Section 203 of CARA requires the Attorney General, in coordination with the DEA Administrator,
the Secretary of Health and Human Services, and the Director of the Office of National Drug
Control Policy, to coordinate with “covered entities” to expand or make available disposal sites
for unwanted prescription drugs.302 The law defines “covered entities” to include state, local, or
tribal law enforcement agencies, drug manufacturers and distributors, retail pharmacies, narcotic
treatment programs, hospitals or clinics with an onsite pharmacy, and long-term care facilities.303
Congress included two chapters relating to drug disposal in the SUPPORT for Patients and
Communities Act that was enacted in October 2018. The first chapter addresses the difficulties
faced by home hospice employees regarding disposal of pharmaceutical controlled substances.
Under the Disposal Act of 2010, a member of a hospice patient’s household may dispose of an
unused controlled substance medication after the patient dies,304 but a home hospice employee
cannot do so unless authorized by law (such as state law).305 Chapter 3 of subtitle B, title III of the
SUPPORT Act, referred to as the “Safe Disposal of Unused Medication Act,” amends the CSA to
allow an employee of a “qualified hospice program”306 to dispose of a controlled substance after
(1) the death of a person receiving hospice care, (2) the expiration of the controlled substance, or
(3) a modification in the plan of care of the hospice patient if the employee is the physician of the
person receiving hospice care and has a DEA registration.307 This chapter also requires the
Comptroller General of the United States, head of the Government Accountability Office (GAO),
to study and report to Congress, not later than 18 months after the SUPPORT Act’s enactment on
October 24, 2018, on the federal requirements applicable to the management and disposal of
controlled substances in the home, as well as the challenges encountered by select qualified
hospice programs regarding the disposal of controlled substances.308
Chapter 6 of subtitle B, title III of the SUPPORT Act, referred to as the “Access to Increased
Drug Disposal Act of 2018,” addresses the relatively low number of pharmacies and other DEA299 Id., adding 21 C.F.R. § 1317.90 and 21 C.F.R. § 1317.95. The regulations define “non-retrievable” to mean a
controlled substance that has been permanently and irreversibly altered such that it is “unavailable and unusable for all
practical purposes.” Id. at 53,560, adding 21 C.F.R. § 1300.05.
300 P.L. 114-198, 130 Stat. 695, 712, 717 (codified at 34 U.S.C. § 10701, 21 U.S.C. § 822a).
301 34 U.S.C. § 10701(a)(9).
302 21 U.S.C. § 822a(b).
303 Id. § 822a(a).
304 Id. § 822(g)(4).
305 Drug Enf’t Admin., Disposal of Controlled Substances, 79 Fed. Reg. 53,520, 53,546 (Sept. 9, 2014).
306 The SUPPORT Act defines a “qualified hospice program” as a hospice program that has written policies and
procedures for disposal of the controlled substance after the patient's death that are in place when the controlled
substance is first ordered and that documents the disposal in the patient's clinical record after disposal is completed. 21
U.S.C. § 822(g)(5)(B)(iii), as added by P.L. 115-271, § 3222(a).
307 21 U.S.C. § 822(g)(5)(A).
308 P.L. 115-271, § 3223.
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registered entities eligible to collect unused prescription drugs for disposal who have voluntarily
sought DEA authorization to become registered collectors.309 This chapter does not directly
amend the CSA but instead provides the Attorney General (acting through the Assistant Attorney
General for the Office of Justice Programs) with authority to make grants to states in an effort to
increase participation rates of eligible collectors as authorized collectors.310 A state seeking a
grant award under this chapter must submit an application that (1) designates a single state
agency responsible for complying with the conditions of the grant, (2) describes a plan to increase
the participation of eligible collectors as authorized collectors, and (3) explains how the state will
select eligible collectors to be served under the grant.311 The Attorney General is required to
award these grants to five states, and at least three of these states must be “in the lowest quartile
of States based on the participation rate of eligible collectors as authorized collectors, as
determined by the Attorney General.”312
Increasing Flexibility With Respect to Medication-Assisted
Treatment for Opioid Addiction
Certain prescription drugs may be used to treat opioid abuse and facilitate recovery from
addiction; this type of practice is commonly referred to as “medication-assisted treatment” or
MAT.313 Currently, the main prescription drugs used in MAT are methadone, buprenorphine,
which are controlled substances under the CSA, and naltrexone, which is not scheduled under the
CSA. The CSA requires any practitioner wanting to administer and dispense methadone (a
Schedule II substance) for the purpose of maintenance treatment314 or detoxification treatment315
to obtain annually a separate DEA registration for that purpose,316 referred to as a “Narcotic
Treatment Program” or NTP registration. (NTPs are also regulated by the Substance Abuse and
Mental Health Services Administration (SAMHSA) in the Department of Health and Human
Services, as well as by state methadone authorities).317 However, a practitioner may apply for and
receive a waiver from this separate registration requirement (commonly known as a “DATA
waiver”) if the controlled substance to be used for addiction treatment outside of a NTP is a
309 U.S. GOV’T ACCOUNTABILITY OFF., GAO-18-25, PREVENTING DRUG ABUSE: LOW PARTICIPATION BY PHARMACIES
AND OTHER ENTITIES AS VOLUNTARY COLLECTORS OF UNUSED PRESCRIPTION DRUGS 7, 13-16 (2017) (finding that
approximately 3% of eligible entities have volunteered to act as authorized collectors, a low rate of participation that
could be attributed to the costs associated with purchasing, installing, and managing the disposal bins and some
confusion over how to comply with the DEA regulations governing these activities).
310 P.L. 115-271, § 3253.
311 Id. § 3254.
312 Id. § 3256.
313 For more information, see CRS In Focus IF10219, Opioid Treatment Programs and Related Federal Regulations,
by (name redacted) .
314 21 U.S.C. §§ 802(29) (“The term ‘maintenance treatment’ means the dispensing, for a period in excess of twentyone days, of a narcotic drug in the treatment of an individual for dependence upon heroin or other morphine-like
drugs.”).
315 Id. §§ 802(30) (“The term ‘detoxification treatment’ means the dispensing, for a period not in excess of one hundred
and eighty days, of a narcotic drug in decreasing doses to an individual in order to alleviate adverse physiological or
psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of
bringing the individual to a narcotic drug-free state within such period.”).
316 Id. § 823(g)(1).
317 DRUG ENF’T ADMIN., 1 NARCOTIC TREATMENT PROGRAMS: BEST PRACTICE GUIDELINES (2000),
https://www.deadiversion.usdoj.gov/pubs/manuals/narcotic/narcotic.pdf.
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Schedule III, IV, or V substance, such as buprenorphine (a Schedule III drug).318 If a medical
professional wishes to prescribe the third type of drug used in MAT, naltrexone, he need not be
registered with the DEA to do so because naltrexone is not a controlled substance under the CSA.
One section of CARA amended the CSA to expand temporarily the types of practitioners who
may, without being separately registered with the DEA as a NTP, dispense buprenorphine or other
narcotic drug in Schedule III, IV, or V, for treating opioid dependence outside of a NTP. Prior to
CARA, only “qualified physicians”319 were permitted to dispense such narcotics for these
purposes; CARA temporarily (until October 1, 2021) expands the categories of practitioners to
include a qualifying nurse practitioner or physician assistant.320 The DEA issued a final rule,
effective January 22, 2018, that implemented the changes made to the CSA by CARA.321 Note
that CARA did not make any changes to who may dispense methadone.
Congress included several provisions relating to MAT in the SUPPORT Act. Chapter 1 of subtitle
B, title III of the SUPPORT Act322 amends the CSA by removing the time limit imposed by
CARA during which nurse practitioners and physician assistants may dispense controlled
substances for maintenance and detoxification treatment under a DATA waiver, effectively
making CARA’s temporary authority permanent.323 This chapter also allows clinical nurse
specialists, certified registered nurse anesthetists, and certified nurse midwives to obtain DATA
waivers until October 1, 2023.324
In addition, the SUPPORT Act addresses issues relating to controlled substances that require a
physician to administer them to a patient by injection or implantation in a medical office. For
example, buprenorphine is a schedule III controlled substance prescribed for treatment of opioid
use disorders that may require administration via injection or implantation.325 However, under the
CSA prior to its amendment by the SUPPORT Act, a pharmacist was prohibited from dispensing
a controlled substance to anyone other than the ultimate user; as such, the pharmacist could not
give a particular controlled substance prescribed for a patient directly to that patient’s
physician.326 The SUPPORT Act amends the CSA by allowing a pharmacy, under specified
conditions, to deliver a controlled substance to a practitioner, pursuant to a prescription, to be
administered by the practitioner to the patient by injection or implantation for the purpose of
maintenance or detoxification treatment.327 The physician must administer the controlled
318 21 U.S.C. § 823(g)(2), 21 C.F.R. § 1301.28.
319 21 U.S.C. § 823(g)(2)(G)(ii) (listing the specific statutory requirements for a physician to be considered a
“qualified” one for purposes of dispensing narcotic drugs for maintenance or detoxification treatment).
320 Id. § 823(g)(2)(G)(iii)(II), (iv).
321 Drug Enf’t Admin., Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016
Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder, 83 Fed. Reg. 3,071 (Jan. 23, 2018) (codified at
21 C.F.R. § 1301.28).
322 P.L. 115-271, §§ 3201-3204.
323 Id. § 3201(b).
324 Id. § 3201(c).
325 For more information, see CRS Report R45279, Buprenorphine and the Opioid Crisis: A Primer for Congress, by
(name redacted) .
326 The CSA defines an “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. 21 U.S.C. § 802(27). The CSA also defines “dispense” to mean “to deliver a controlled substance to
an ultimate user ... by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a
controlled substance.” Id. § 802(10).
327 P.L. 115-271, § 3204(a), adding new Section 309A to the CSA (codified at 21 U.S.C. § 829a).
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substance to the patient within 14 days after the physician has received the controlled
substance.328 The Attorney General, in coordination with the Secretary of Health and Human
Services, may reduce the number of days within which the physician must administer the
controlled substance if such reduction will reduce risk of diversion or protect public health;
however, the Attorney General cannot make a modification that is less than seven days.329 The
SUPPORT Act requires the GAO to study and submit a report to Congress on access to and
potential diversion of controlled substances administered by injection or implantation not later
than two years after the Act’s enactment.330
Providing Manufacturers and Distributors Certain ARCOS Data
As discussed previously in this report, manufacturers and distributors of Schedule I and II drugs
must report their controlled substances transactions to the DEA through the Automated Reports
and Consolidated Orders System (ARCOS).331 Chapter 7 of subtitle B, title III of the SUPPORT
Act,332 referred to as the “Using Data to Prevent Opioid Diversion Act of 2018,” is intended “to
provide drug manufacturers and distributors with access to anonymized information through
ARCOS to help drug manufacturers and distributors identify, report, and stop suspicious orders of
opioids and reduce diversion rates.”333 This chapter amends the CSA to require the DEA
Administrator to make certain data available to registered manufacturers and distributors through
the ARCOS system on a quarterly basis; it covers the total number of registrants that distribute
controlled substances to a pharmacy or practitioner registrant and the total quantity and type of
opioids distributed to each pharmacy and practitioner registrant.334 These provisions impose an
affirmative obligation on manufacturers and distributors to review this ARCOS information335
and establish new civil and criminal penalties for failure to do so.336 Furthermore, these
provisions provide that the DEA Administrator may consider a failure of a manufacturer or
distributor to review this information in determining whether to initiate administrative actions
against the registrant for noncompliance with CSA requirements.337
The legislation also requires the Attorney General to submit to Congress within one year of
enactment of the act a report that provides information about how the Attorney General is using
data in ARCOS to identify and stop suspicious activity.338
328 Id.
329 Id.
330 P.L. 115-271, § 3204(b).
331
21 C.F.R. §§ 1304.31 and 1304.32.
332 P.L. 115-271, §§ 3271-3274.
333 Id. § 3272(a).
334 Id. § 3273(a)(2), adding new 21 U.S.C. § 827(f)(1).
335 21 U.S.C. § 827(f)(3)(A).
336 P.L. 115-271, § 3273(c), amending 21 U.S.C. § 842.
337 21 U.S.C. § 827(f)(3)(B).
338 P.L. 115-271, § 3274.
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Adding Considerations for DEA Opioid Quotas
Chapter 8 of subtitle B, title III of the SUPPORT Act,339 referred to as the “Opioid Quota Reform
Act,” amends the CSA340 by adding statutory considerations for the DEA in establishing annual
production quotas (APQ) for schedule I and II controlled substances.341 In establishing the annual
medical, scientific, and research need for a controlled substance, the DEA Administrator may, if
he determines it will help to address “overproduction, shortages, or diversion of a controlled
substance, establish an aggregate or individual production quota,” or a procurement quota that he
has set by regulation, “in terms of pharmaceutical dosage forms prepared from or containing the
controlled substance.”342 In addition, in establishing annual quotas for the production of fentanyl,
oxycodone, hydrocodone, oxymorphone, or hydromorphone, the SUPPORT Act requires the DEA
Administrator to estimate the amount of diversion of these particular controlled substances that
occurs in the United States and then make appropriate reductions from the quota the DEA
Administrator would have otherwise established had such diversion not been considered.343
Strengthening Requirements to Detect and Report Suspicious
Orders
Prior to being amended by the SUPPORT Act, the statutory text of the CSA did not require
registrants to design and operate a system to disclose to them any suspicious orders of controlled
substances and to report such orders to the DEA; rather, such requirements appeared in DEA
regulations.344 The CSA’s definitions section also lacked a definition of the term “suspicious
order.” Chapter 9 of subtitle B, title III of the SUPPORT Act,345 referred to as the “Preventing
Drug Diversion Act of 2018,” adds a statutory definition of “suspicious order” to the CSA that
essentially adopts the language of the existing regulatory definition.346 These provisions also add
a new section to the CSA entitled “Suspicious Orders,” which requires a DEA registrant to take
essentially the same actions as those required under the DEA regulation: (1) to design and operate
a system (that is compliant with applicable federal and state privacy laws) that will alert the
registrant of suspicious orders of controlled substances, and (2) upon discovering a suspicious
order or series of orders, to inform the DEA Administrator and the Special Agent in Charge of the
DEA Field Division Office.347 The SUPPORT Act provisions also require the DEA Administrator,
within a year of the act’s enactment, to establish a centralized database for storing suspicious
339 P.L. 115-271, §§ 3281-3282.
340 21 U.S.C. § 826.
341 In making his APQ determinations, the DEA Administrator is also required to consider several factors provided by
regulation, 21 C.F.R. §§ 1303.11(b)(1)-(7), as described earlier in this report under the “Quotas” section.
342 P.L. 115-271, § 3282(a), adding new 21 U.S.C. § 826(a)(2).
343 Id., adding new 21 U.S.C. § 826(i)(1).
344 21 C.F.R. §1301.74(b).
345 P.L. 115-271, §§ 3291-3292.
346 P.L. 115-271, § 3292(a), adding new 21 U.S.C. § 802(57).
347 P.L. 115-271, § 3292(b), adding new 21 U.S.C. § 832. However, there are a few differences between the statutory
requirements concerning suspicious orders under the new CSA suspicious orders section and the regulatory
requirements under 21 C.F.R. §1301.74(b). For example, the new statutory provision directs the registrant to notify the
DEA Administrator in addition to the DEA Field Division Office about suspicious orders (the regulations specify only
the latter as the point of contact) and requires the registrant to ensure that the system used to identify suspicious orders
complies with federal and state privacy laws (the applicable regulations do not reference privacy laws). Compare P.L.
115-271, § 3292 (adding 21 U.S.C. § 832) with 21 C.F.R. § 1301.74(b).
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orders reports; if a registrant submits a suspicious order to this database, the registrant is
considered to have complied with the notification requirement mentioned above.348 The DEA
Administrator must share information regarding suspicious orders for prescription controlled
substances in a state with an entity designated by the governor or chief executive officer of that
state.349
The SUPPORT Act also establishes a maximum criminal fine of $500,000 for registered
manufacturers or distributors of opioids who intentionally fail to report suspicious orders for
opioids.350
Other Legislative Proposals That the 116th Congress
Could Consider to Amend the CSA
The 116th Congress may consider legislation to amend the CSA beyond the changes made by the
SUPPORT Act. These potential additional amendments to the CSA may resemble opioid
legislation introduced, but not enacted to date, in the 115th Congress. Legislative proposals
introduced in the 115th Congress include the following:
Changes to the DEA’s Authority to Deny, Revoke, or Suspend a
Registration, and to Issue Immediate Suspension Orders. The DEA Opioid
Enforcement Restoration Act of 2017 (H.R. 4095) would repeal the Ensuring
Patient Access and Effective Drug Enforcement Act of 2016 (EPAEDEA) (P.L.
114-145), discussed above in the section describing the DEA’s authority to issue
“immediate suspension orders,” and would
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