Legal Sidebari
Recent Developments in Opioid Regulation
Under the Controlled Substances Act
November 22, 2022
In recent years, policymakers have devoted significant attention to opioid regulation, seeking in particular
to combat the epidemic of opioid misuse and overdoses. Opioids are drugs derived from the opium poppy
or emulating the effects of opium-derived drugs. Some opioids have legitimate medical uses related to
pain management, while others have no recognized medical use. Both pharmaceutical opioids (such as
oxycodone, codeine, and morphine) and non-pharmaceutical opioids (such as heroin) may pose a risk of
abuse and dependence and may be dangerous or even deadly in certain doses.
In recent years, Congress has considered how to regulate non-pharmaceutical analogues to the powerful
opioid fentanyl. At the same time, courts, advocates, and the executive branch have grappled with the
legal status of supervised consumption sites—facilities where illicit drug users can consume opioids
under the supervision of trained staff, receive medical intervention in case of an overdose, and access
services including addiction treatment.
This Legal Sidebar provides information for Congress on recent developments in opioid regulation, with a
focus on regulation under the federal Controlled Substances Act (CSA). The Sidebar first provides
background information on the legal status of opioids. It then discusses recent legal developments related
to fentanyl analogues and supervised consumption sites. The Sidebar closes with a summary of selected
proposals from the 117th Congress that would address other issues related to opioid regulation.
Background on Opioid Regulation
Opioids are subject to regulation under multiple provisions of federal and state law. At the federal level,
prescription opioids are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Many
pharmaceutical and non-pharmaceutical opioids are controlled substances under the CSA. (Many other
prescription drugs are not controlled substances.) Opioids are also often subject to state controlled
substance laws. This Legal Sidebar focuses on regulation of opioids under the CSA.
The CSA regulates drugs and other substances—whether medical or recreational, legally or illicitly
distributed—that pose a risk of abuse and dependence. Substances become subject to the CSA through
placement in one of five lists, known as Schedules I through V. A lower schedule number carries greater
restrictions, so controlled substances in Schedule I are subject to the most stringent controls. Schedule I
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controlled substances have no currently accepted medical use, and it is illegal to produce, dispense, or
possess them except in the context of federally approved scientific studies. By contrast, substances in
Schedules II through V have accepted medical uses and may be dispensed for medical purposes, usually
by prescription. A substance can be placed in a CSA schedule, moved to a different schedule, or removed
from CSA control either by legislation or through an administrative rulemaking process overseen by the
Drug Enforcement Administration (DEA) and based on criteria in the CSA.
A substance not specifically designated for control in Schedules I through V may be subject to the CSA as
a controlled substance analogue. A controlled substance analogue is a substance not otherwise approved
by the Food and Drug Administration or scheduled under the CSA that has (1) a chemical structure
substantially similar to that of a controlled substance in Schedule I or II or (2) an actual or intended effect
that is “substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect ... of a
controlled substance in schedule I or II.” A substance that meets those criteria and is intended for human
consumption is treated as a controlled substance in Schedule I.
A number of pharmaceutical and non-pharmaceutical opioids are controlled substances. For instance,
fentanyl is in Schedule II, as it has recognized medical uses. Methadone, oxycodone, and
hydromorphone—medications used for multiple purposes including to treat pain—are also in Schedule II.
Cough medicines containing small amounts of codeine are in Schedule V. Some non-pharmaceutical
substances chemically related to fentanyl are in Schedule I. To the extent other opioids are not specifically
scheduled under the CSA, they may still fall under CSA control as controlled substance analogues.
Fentanyl Analogues
One question before the 117th Congress has been how to regulate analogues of fentanyl. As noted above,
fentanyl itself is in Schedule II, and some analogues of fentanyl are controlled in Schedule I or II.
However, it is possible to modify the fentanyl molecule, producing substances that are chemically related
to fentanyl but are not individually scheduled under the CSA.
On February 6, 2018, DEA exercised its power to place a substance in Schedule I temporarily when
“necessary to avoid an imminent hazard to the public safety” by issuing a temporary scheduling order
(Fentanyl TSO) that placed certain “fentanyl-related substances” in Schedule I for two years. While
previous scheduling actions by DEA and Congress generally identified a specific substance or a list of
discrete substances for control, the Fentanyl TSO instead imposed controls on a broad class of fentanyl-
related substances that met specific criteria related to their chemical structure. While that class of
substances is finite, it includes thousands of chemicals. As one researcher testified before Congress, the
effects, potential for abuse and dependence, and medical utility of many of those substances are unknown.
Perhaps because of those uncertainties, DEA did not initiate permanent scheduling of the class of
substances subject to the Fentanyl TSO, though the agency has continued to take temporary and
permanent scheduling actions with respect to specific fentanyl analogues, including selected fentanyl-
related substances subject to the Fentanyl TSO. By statute, DEA rulemaking permanently scheduling a
controlled substance must be supported by certain factual findings. January 2020 testimony from an
official in the Department of Health and Human Services (HHS) suggested that, given the large number of
substances subject to the order, it was not feasible to make the individualized findings required to
schedule each substance permanently. Congress is not required to make the same findings to schedule a
substance via legislation.
On February 6, 2020, Congress enacted the Temporary Reauthorization and Study of the Emergency
Scheduling of Fentanyl Analogues Act, which temporarily extended the Fentanyl TSO until May 6, 2021.
Congress has since extended the Fentanyl TSO several times. The most recent extension expires
December 31, 2022. If the temporary scheduling expires, some unscheduled opioids related to fentanyl
may remain subject to regulation under the CSA as controlled substance analogues. However, DEA has
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explained that it must prove additional elements in analogue prosecutions, so such “prosecutions are time-
consuming, resource-intensive, and difficult for investigators,” and their outcomes may be unpredictable.
Some stakeholders, including DEA and HHS, have called for Congress to impose permanent controls on
the class of fentanyl-related substances subject to the Fentanyl TSO or a similar class of fentanyl
analogues. A previous CRS Legal Sidebar discusses some questions Congress might consider when
deciding whether and how to regulate fentanyl analogues, including how to define the category of
substances subject to control, how those substances should fit into the CSA’s criminal enforcement and
sentencing regimes, and whether placing fentanyl analogues in Schedule I might impede research into
potential medical uses.
Members of the 117th Congress have introduced multiple legislative proposals that would permanently
schedule a class of fentanyl analogues. Some proposals would permanently place the class of substances
subject to the Fentanyl TSO in Schedule I. Some would schedule the class of fentanyl-related substances
subject to the Fentanyl TSO plus certain specific substances. Some proposals would seek to facilitate
research on substances subject to class-wide scheduling or provide for expedited descheduling if a
fentanyl-related substance were found not to pose a risk of abuse and dependence. In addition, some
legislative proposals would provide that mandatory minimum sentences under the CSA would not apply
to those who committed certain offenses involving fentanyl-related substances.
Supervised Consumption Sites
Another recent issue related to opioid regulation is the legal status of supervised consumption sites under
a provision of the CSA, 21 U.S.C. § 856 (Section 856). Supervised consumption sites are facilities that
pursue a harm reduction strategy by permitting the use of controlled substances in the presence of staff
who can administer overdose-reversal medications, distributing medical supplies such as sterile syringes,
and offering referrals to substance use treatment. Congress first enacted Section 856 in 1986 in response
to concerns about “crack houses”—premises where illicit drugs such as crack cocaine were manufactured,
stored, distributed, and used. Congress amended the provision in 2003 to target facilities where attendees
distributed and used drugs such as MDMA.
Section 856 contains two criminal prohibitions. First, Section 856(a)(1) provides that it is unlawful to
“knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the
purpose of manufacturing, distributing, or using any controlled substance.” Second, Section 856(a)(2)
imposes criminal penalties on those who “manage or control any place ... and knowingly and intentionally
rent, lease, profit from, or make available for use, with or without compensation, the place for the purpose
of unlawfully manufacturing, storing, distributing, or using a controlled substance.” The first provision
prohibits an entity from maintaining premises for its own drug-related activities, while the second
prohibits making premises available for drug-related activity by third parties. Supervised consumption
sites and their staff generally do not produce, distribute, or otherwise handle drugs, so legal questions
related to such facilities center on Section 856(a)(2).
In 2018, a nonprofit called Safehouse announced plans to open a supervised consumption site in
Philadelphia. The U.S. Department of Justice (DOJ) sued Safehouse to block the proposed facility,
arguing that the supervised consumption site would violate Section 856. As discussed in a previous CRS
Legal Sidebar, in October 2019, a federal district court ruled that the planned facility would not violate
the CSA because Section 856 does not apply to supervised consumption sites such as Safehouse.
The United States appealed. On January 12, 2021, in United States v. Safehouse, the U.S. Court of
Appeals for the Third Circuit reversed the district court. Safehouse argued that in operating a supervised
consumption site it lacked the requisite intent to violate Section 856. A majority of the three-judge panel
disagreed, holding that Safehouse need not “have the purpose that its visitors use drugs” but rather “need
only ‘knowingly and intentionally’ open its site to visitors who come ‘for the purpose of ... using’ drugs.”
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In any event, the court concluded that, in “offer[ing] visitors a space to inject themselves with drugs,”
Safehouse would violate Section 856 because the organization “itself has a significant purpose that its
visitors use heroin, fentanyl, and the like.” In response to Safehouse’s argument that this application was
not what Congress intended when it enacted and amended Section 856, the majority held that the text of
the statute was clear, so the court need not look beyond the text to other indicia of congressional intent.
One member of the Third Circuit panel dissented. Judge Roth contended that text of Section 856 is
ambiguous, and the majority erred in construing the ambiguous text in a way that imposed broad criminal
liability. She would have also held that Safehouse lacked the requisite intent to violate Section 856
because it “is not motivated at least in part by a desire for unlawful drug activity to occur and ... in fact
wants to reduce drug activity.” The Supreme Court declined to review the Third Circuit’s decision.
At the time of writing, Safehouse has not commenced operation. However, other states and localities have
also begun considering whether to authorize such facilities. At the time of the district court decision in the
Safehouse litigation, there were already multiple reports of a supervised consumption site operating in
secret in an undisclosed location, and local governments and other organizations outside Philadelphia had
begun to consider similar facilities. In July 2021, Rhode Island enacted legislation authorizing supervised
consumption sites under state law. The Illinois, Massachusetts, and New Mexico state legislatures have
also considered legislation related to supervised consumption sites. The California legislature passed
legislation in 2022 that would have allowed supervised consumption sites to operate on a trial basis in
three cities, but the governor vetoed it, expressing concerns that the legislation might inadvertently
“[w]orsen[ ] drug consumption challenges” in those cities.
In November 2021, two supervised consumption sites began operating openly in New York City with the
approval of the city government. The city reported that the sites were used 2,000 times in their first three
weeks of operation and averted at least 59 potential overdose deaths. While DOJ actively opposed the
operation of supervised consumption sites under the Trump Administration, to date the Biden
Administration has not sought to invoke the CSA against such facilities. In February 2022, DOJ stated
that it was “evaluating supervised consumption sites, including discussions with state and local regulators
about appropriate guardrails for such sites, as part of an overall approach to harm reduction and public
safety.”
In the meantime, uncertainty remains as to the legality of supervised consumption sites under the CSA.
Congress could resolve that uncertainty by enacting legislation. If Congress decided to allow supervised
consumption sites to operate, it could consider the breadth of such authorization. One option would be to
exempt supervised consumption sites from CSA control entirely. Alternatively, Congress might choose to
exempt from federal prosecution facilities operating in compliance with state and local law, as it has done
with state-sanctioned medical marijuana activities through a series of appropriations riders. Another
option would be for Congress to impose specific registration requirements for supervised consumption
sites under the CSA, as it has done for entities that administer medication-assisted treatment for opioid
addiction.
If Congress decided not to allow supervised consumption sites, it could amend Section 856 to prohibit
those facilities explicitly (as it did with other activities in 2003) or enact separate legislation to ban
supervised consumption sites. Congress could also use its spending power to limit supervised
consumption sites. For example, a proposal from the 117th Congress would prohibit federal funds from
being “used by any Federal agency to operate or control ... an injection center” that violates Section 856.
Others would limit the availability of federal funds to states, localities, Indian tribes, and other entities
that operate supervised consumption sites in violation of Section 856.
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Other Legislative Proposals
Outside the context of fentanyl analogues and supervised consumption sites, the 117th Congress has seen
multiple proposals that would change how opioids are regulated under the CSA. (Numerous additional
proposals that would alter how opioids are regulated under the FD&C Act or other provisions of law are
outside the scope of this Sidebar.)
Some proposals would change the regulatory obligations of CSA registrants authorized to handle opioids.
For instance, the LABEL Opioids Act (H.R. 1026/S. 2353) would require certain opioid medications
subject to the CSA to bear a “clear, concise warning that the opioid dispensed can cause dependence,
addiction, and overdose.” The MATE Act of 2021 (S. 2235) would “require physicians and other
prescribers of controlled substances to complete training on treating and managing patients with opioid
and other substance use disorders.” The Mainstreaming Addiction Treatment Act of 2021 (H.R. 1384/S.
445) would relax CSA registration requirements for practitioners who dispense narcotic drugs in
Schedules III, IV, or V (such as buprenorphine) for maintenance or detoxification treatment. The Harm
Reduction Through Community Engagement Act of 2022 (H.R. 8917) would impose additional
registration requirements for opioid treatment programs. The Opioid QuOTA Act of 2021 (H.R. 6150/S.
3327) would require publication of the annual quotas that apply to each registered opioid manufacturer.
Other proposals would amend the CSA’s criminal provisions that apply to unauthorized activities
involving opioids. Some proposals would increase criminal penalties for certain fentanyl-related offenses,
imposing life in prison or the death penalty. Others would lower the amounts of fentanyl or fentanyl
analogues required to trigger existing mandatory minimum sentences. Some proposals would target
misrepresenting the content of a substance containing fentanyl or the manufacture of counterfeit
substances that contain fentanyl and bear identifying marks of another product. Another proposal would
authorize special agents of Homeland Security Investigations to perform certain enforcement functions
under the CSA.
Author Information
Joanna R. Lampe
Legislative Attorney
Disclaimer
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