Comparison of Proposed Legislation Concerning Fentanyl-Related Substances

Comparison of Proposed Legislation Concerning Fentanyl-Related Substances

Comparison of Proposed Legislation
May 24, 2023
Concerning Fentanyl-Related Substances
Joanna R. Lampe
On February 6, 2018, the Drug Enforcement Administration (DEA) issued a temporary
Legislative Attorney
scheduling order that placed certain “fentanyl-related substances” (FRS) in Schedule I of the

Controlled Substances Act (CSA) for two years. Placing a drug or other substance in Schedule I
Lisa N. Sacco
reflects a finding that the substance has no currently accepted medical use and a high potential
Analyst in Illicit Drugs and
for abuse. While previous scheduling actions by both DEA and Congress identified a specific
Crime Policy
substance or a list of several discrete substances for control, the FRS temporary scheduling order

instead imposed controls on a broad class of FRS that met specific criteria related to their
chemical structure. Although that class of substances is finite, it includes thousands of different

chemicals.
For multiple reasons, including the statutory and practical limitations on DEA’s scheduling authority, Congress has extended
the FRS temporary scheduling order several times, most recently on December 29, 2022. The order is now set to expire on
December 31, 2024.
This report compares the treatment of FRS under two bills introduced during the 118th Congress: the Save Americans from
the Fentanyl Emergency Act (SAFE Act, H.R. 568) and the Halt All Lethal Trafficking of Fentanyl Act (HALT Fentanyl
Act, H.R. 467). The report discusses both proposals in relation to current law under the CSA. This report focuses on these
two bills due to planned floor activity for the week of May 22, 2023, and the similarities between the two bills.
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Contents
Tables
Table 1. Comparison of the SAFE Act and the HALT Fentanyl Act with Current Federal
Law ............................................................................................................................................... 2

Contacts
Author Information ......................................................................................................................... 11

Congressional Research Service

Comparison of Proposed Legislation Concerning Fentanyl-Related Substances

This report compares the treatment of certain fentanyl-related substances (FRS) under two bills
introduced during the 118th Congress: the Save Americans from the Fentanyl Emergency Act
(SAFE Act, H.R. 568) and the Halt All Lethal Trafficking of Fentanyl Act (HALT Fentanyl Act,
H.R. 467). The report discusses both proposals in relation to current law under the Controlled
Substances Act (CSA).1 The report focuses on these two bills due to planned floor activity for the
week of May 22, 2023, and the similarities between the two bills.
As background, on February 6, 2018, the Drug Enforcement Administration (DEA) issued a
temporary scheduling order that placed certain FRS in Schedule I under the CSA for two years.2
The order defined FRS as follows:
(i) Fentanyl-related substance means any substance not otherwise listed under another
Administration Controlled Substance Code Number, and for which no exemption or
approval is in effect under section 505 of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. § 355], that is structurally related to fentanyl by one or more of the following
modifications:
(A) Replacement of the phenyl portion of the phenethyl group by any monocycle, whether
or not further substituted in or on the monocycle;
(B) Substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo,
haloalkyl, amino or nitro groups;
(C) Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether,
hydroxyl, halo, haloalkyl, amino or nitro groups;
(D) Replacement of the aniline ring with any aromatic monocycle whether or not further
substituted in or on the aromatic monocycle; and/or
(E) Replacement of the N-propionyl group by another acyl group.3
DEA subsequently began permanent scheduling proceedings for certain specific FRS but not for
the full class of FRS.4 Before DEA completed those proceedings, on February 6, 2020, Congress
enacted the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl
Analogues Act (P.L. 116-114), which extended the temporary scheduling order until May 6,
2021.5 Congress has since extended the temporary scheduling order several times, often through
appropriations law:
• The Extending Temporary Emergency Scheduling of Fentanyl Analogues Act
(P.L. 117-12) extended the temporary scheduling order until October 22, 2021.
• The Extending Government Funding and Delivering Emergency Assistance Act
(P.L. 117-43) extended the temporary scheduling order until January 28, 2022.

1 21 U.S.C. § 801 et seq. For more information on the Controlled Substances Act, see CRS Report R45948, The
Controlled Substances Act (CSA): A Legal Overview for the 118th Congress, by Joanna R. Lampe. This report refers to
the version of the SAFE Act introduced in the House on January 26, 2023, and the version of the HALT Fentanyl Act
reported in the House on May 17, 2023.
2 DEA, Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I, 83
Fed. Reg. 5,188 (Feb. 6, 2018). Fentanyl itself is in Schedule II, as it has recognized medical uses. Multiple non-
pharmaceutical substances chemically related to fentanyl are controlled in Schedule I. See generally 21 C.F.R.
§§ 1308.11-1308.12.
3 83 Fed. Reg. at 5191-92 (brackets in original).
4 See, e.g., DEA, Schedules of Controlled Substances: Placement of Four Specific Fentanyl-Related Substances in
Schedule I, 86 Fed. Reg. 14,707 (Mar. 18, 2021) (proposed action).
5 S. 3201 (116th Cong. 2020).
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• The Further Extending Government Funding Act (P.L. 117-70) extended the
temporary scheduling order until February 18, 2022.
• The Further Additional Extending Government Funding Act (P.L. 117-86)
extended the temporary scheduling order until March 11, 2022.
• The Extension of Continuing Appropriations Act, 2022 (P.L. 117-95), extended
the temporary scheduling order until March 15, 2022.
• The Consolidated Appropriations Act, 2022 (P.L. 117-103), extended the
temporary scheduling order until December 31, 2022.
• Most recently, the Consolidated Appropriations Act, 2023 (P.L. 117-328),
extended the temporary scheduling order until December 31, 2024.
Absent further legislative or administrative action,6 the full class of FRS is to remain in Schedule
I until December 31, 2024, and is subject to all restrictions and penalties applicable to Schedule I
substances until that date. If the temporary scheduling expires, FRS would no longer be scheduled
under the CSA as a class, though they may still be subject to control as controlled substance
analogues.7 DEA (or Congress) may also continue to schedule specific FRS.

6 As mentioned, DEA has continued to individually schedule specific fentanyl analogues that were included in the class
of FRS. However, DEA and the Department of Justice (DOJ) have indicated that they are unable to keep pace with the
onset of new fentanyl analogues and scheduling of these substances, and DOJ has asked that Congress schedule all FRS
as a class. See DEA, Statement of the U.S. Department of Justice Before the House Energy and Commerce Committee,
Subcommittee on Health, U.S. House of Representatives for a Hearing Entitled, The Overdose Crisis: Interagency
Proposal to Combat Illicit Fentanyl-Related Substances, December 2, 2021,
https://www.justice.gov/sites/default/files/testimonies/witnesses/attachments/2022/08/09/2021.012.02_doj_statement_r
e_overdose_crisis_frs.pdf.
7 For further discussion of regulation of controlled substance analogues, see CRS Legal Sidebar LSB10865, Recent
Developments in Opioid Regulation Under the Controlled Substances Act, by Joanna R. Lampe.
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Table 1 contains a CRS comparison of the current law regarding FRS (including temporary
scheduling), the law if Congress were to enact the SAFE Act, and the law if Congress were to
enact the HALT Fentanyl Act.

Congressional Research Service

1

Table 1. Comparison of the SAFE Act and the HALT Fentanyl Act with Current Federal Law
Current Law/Regulation
SAFE Act (H.R. 568)
HALT Fentanyl Act (H.R. 467)
21 C.F.R. § 1308.11 Schedule I.
Sec. 2. Class Scheduling of Fentanyl-Related
Sec. 2. Class Scheduling of Fentanyl-Related
21 C.F.R. § 1308.11(h) provides for temporary
Substances.
Substances.
scheduling of “Fentanyl-related substances, their
This section would amend the CSA, 21 U.S.C. §
This section would amend the CSA, 21 U.S.C. §
isomers, esters, ethers, salts and salts of isomers,
812(c), to add FRS to Schedule I permanently in a new
812(c), to add FRS to Schedule I permanently in a new
esters and ethers.” Pursuant to P.L. 117-328, the
subsection, Schedule I(e). The proposal uses a
subsection, Schedule I(e). The proposal uses a
temporary scheduling of FRS is currently in effect until
definition of FRS that is substantially the same as the
definition of FRS that is substantially the same as the
December 31, 2024.
current definition, defining FRS as a class based on
current definition, defining FRS as a class based on
21 C.F.R. § 1308.11(i) defines FRS as outlined above.
their chemical structure.
their chemical structure.
Fentanyl itself and some related chemicals, including
The bil would expressly provide that substances that
The bil would expressly provide that substances that
some that would otherwise qualify as FRS, have been
are individually scheduled, rescheduled, or removed
are individually scheduled shall not be considered FRS.
individually control ed in Schedules I and II on a
from control shall not be considered FRS. It would
The proposal would authorize the Attorney General
permanent basis. The definition of FRS includes only
further provide that FRS shall not be subject to
(as delegated to DEA) to publish a list of individual
substances not individually scheduled. Thus, the
specified quantity-based mandatory minimum penalties. substances that meet the definition of FRS. Similar to
classification of fentanyl and specific control ed
Section 3 of the bil , discussed below, would also limit
the SAFE Act, it would provide that “[t]he absence of
substances related to fentanyl would not change under
the applicability of mandatory minimums for FRS.
a substance from [such a list] does not negate the
either bil or if the temporary scheduling of FRS
The proposal would authorize the Attorney General
control status of the substance under this schedule if
expires.
(as delegated to DEA) to publish a list of individual
the substance satisfies the definition of the term
substances that meet the definition of FRS. It would
‘fentanyl-related substance.’”
provide that “[t]he absence of a substance on any such
Unlike the SAFE Act, the HALT Fentanyl Act would
list does not negate the control status of such
not exempt FRS from quantity-based mandatory
substance if the substance meets the criteria” for
minimum sentences.
treatment as FRS. Thus, it appears such a list would be
intended to provide notice of some substances that
qualify as FRS without limiting the class of covered
substances.
21 U.S.C. § 841 Prohibited acts A.
Sec. 3. Penalty Provisions with Respect to
Sec. 5. Penalties.
21 U.S.C. § 841(b)(1)(A)(vi) imposes a mandatory
Fentanyl-Related Substances—Domestic
The HALT Fentanyl Act would amend 21 U.S.C.
minimum sentence of 10 years in prison for offenses
Offenses.
§ 841(b)(1)(A)(vi) and 21 U.S.C. § 841(b)(1)(B)(vi) to
including the manufacture, distribution, or possession
The SAFE Act would amend 21 U.S.C.
provide expressly that quantity-based mandatory
with intent to distribute 400 grams or more of a
§ 841(b)(1)(A)(vi) to apply a 10-year mandatory
minimum prison sentences that currently apply to
mixture or substance containing a detectable amount
minimum prison sentence to offenses involving
certain offenses involving analogues of fentanyl also
of fentanyl or 100 grams or more of a mixture or
•
apply to offenses involving “fentanyl-related

400 grams or more of a mixture or
substance containing any analogue of fentanyl.
substance containing a detectable amount of
substance[s].”
fentanyl or
CRS-2

Current Law/Regulation
SAFE Act (H.R. 568)
HALT Fentanyl Act (H.R. 467)
21 U.S.C. § 841(b)(1)(B)(vi) imposes a mandatory
•
100 grams or more of a mixture or
minimum sentence of five years in prison for offenses
substance containing a detectable amount of
including the manufacture, distribution, or possession
any analogue of fentanyl that is in Schedule I or
with intent to distribute 40 grams or more of a
II or treated as a Schedule I control ed substance
mixture or substance containing a detectable amount
pursuant to the CSA’s analogue control ed
of fentanyl or 10 grams or more of a mixture or
substance provision, except for a FRS in
substance containing any analogue of fentanyl.
Schedule I(e).
While this statute does not define what constitutes an
The bil would also amend 21 U.S.C. § 841(b)(1)(B)(vi)
analogue of fentanyl, it appears that FRS may be
to apply a five-year mandatory minimum prison
treated as analogues of fentanyl for purposes of these
sentence to offenses involving
provisions.
•
40 grams or more of a mixture or substance
Other aggravating factors, such as repeated offenses
containing a detectable amount of fentanyl or
or causing serious bodily injury or death, may also
•
yield mandatory minimum sentences.

10 grams or more of a mixture or substance
containing a detectable amount of any
analogue of fentanyl that is in Schedule I or II
or treated as a Schedule I controlled substance
pursuant to the CSA’s analogue control ed
substance provision, except for a FRS in
Schedule I(e).
The effect of these amendments would be to state
expressly that the quantity-based mandatory minimum
penalties for fentanyl analogues apply to fentanyl
analogues in Schedules I and II and unscheduled
substances related to fentanyl that qualify as control ed
substance analogues under 21 U.S.C. § 813. It would
also exempt offenses involving FRS in Schedule I(e)
from mandatory minimum sentences based on the
quantity of drugs at issue. Other aggravating factors
could stil yield mandatory minimums for certain FRS
offenses.
21 U.S.C. § 960 Prohibited acts A.
Sec. 4. Penalty Provisions with Respect to
Sec. 5. Penalties.
21 U.S.C. § 960(b)(1)(F) imposes a mandatory
Fentanyl-Related Substances—Import and
The HALT Fentanyl Act would amend 21 U.S.C.
minimum sentence of 10 years in prison for offenses
Export Offenses.
§ 960(b)(1)(F) and 21 U.S.C. § 960(b)(2)(F) to provide
including unauthorized export or import of 400 grams
The SAFE Act would amend 21 U.S.C. § 960(b)(1)(F)
expressly that quantity-based mandatory minimum
or more of a mixture or substance containing a
to apply a 10-year mandatory minimum prison
prison sentences that currently apply to certain
detectable amount of fentanyl or 100 grams or more
sentence to offenses involving
CRS-3

Current Law/Regulation
SAFE Act (H.R. 568)
HALT Fentanyl Act (H.R. 467)
of a mixture or substance containing any analogue of
•
400 grams or more of a mixture or
offenses involving analogues of fentanyl also apply to
fentanyl.
substance containing a detectable amount of
offenses involving “fentanyl-related substance[s].”
21 U.S.C. § 960(b)(2)(F) imposes a mandatory
fentanyl or
minimum sentence of five years in prison for offenses
•
100 grams or more of a mixture or
including unauthorized export or import of 40 grams
substance containing a detectable amount of
or more of a mixture or substance containing a
any analogue of fentanyl that is in Schedule I or
detectable amount of fentanyl or 10 grams or more of
II or treated as a Schedule I control ed substance
a mixture or substance containing any analogue of
pursuant to the CSA’s analogue control ed
fentanyl.
substance provision, except for a FRS in
While this statute does not define what constitutes an
Schedule I(e).
analogue of fentanyl, it appears that FRS may be
The bil would also amend 21 U.S.C. § 960(b)(2)(F) to
treated as analogues of fentanyl for purposes of these
apply a five-year mandatory minimum prison sentence
provisions.
to offenses involving
Other aggravating factors, such as repeated offenses
•
40 grams or more of a mixture or substance
or causing serious bodily injury or death, may also
containing a detectable amount of fentanyl or
yield mandatory minimum sentences.
•
10 grams or more of a mixture or substance
containing a detectable amount of any
analogue of fentanyl that is in Schedule I or II
or treated as a Schedule I controlled substance
pursuant to the CSA’s analogue control ed
substance provision, except for a FRS in
Schedule I(e).
The effect of these amendments would be to state
expressly that the quantity-based mandatory minimum
penalties for fentanyl analogues apply to fentanyl
analogues in Schedules I and II and unscheduled
substances related to fentanyl that qualify as control ed
substance analogues under 21 U.S.C. § 813. It would
also exempt offenses involving FRS in Schedule I(e)
from mandatory minimum sentences based on the
quantity of drugs at issue. Other aggravating factors
could stil yield mandatory minimums for certain FRS
offenses.
CRS-4

Current Law/Regulation
SAFE Act (H.R. 568)
HALT Fentanyl Act (H.R. 467)
Rescheduling or descheduling.
Sec. 5. Removal from Schedule I of Fentanyl-
No related provision.
Either Congress or DEA can schedule, reschedule, or
Related Substances.
The HALT Fentanyl Act would not provide for
deschedule a control ed substance, including FRS.
The SAFE Act would add a new subsection to 21
expedited descheduling or rescheduling of FRS. It
Congress can take scheduling actions through
U.S.C. § 811 providing special procedures for
would remain possible for Congress to change the
legislation. DEA makes permanent scheduling decisions expedited descheduling or rescheduling of FRS
status of FRS via legislation or for DEA to do so
through an administrative process outlined in 21
deemed to pose a limited potential for abuse.
through generally applicable CSA scheduling
U.S.C. § 811 that involves participation by other
If the Secretary of Health and Human Services
procedures.
agencies and the public. DEA’s permanent scheduling
determines that a FRS has a potential for abuse that is
decisions can take years to consider and finalize.
less than the substances in Schedule V and submits to
When Congress adds, removes, or amends the
DEA a scientific and medical evaluation supporting its
schedule of a control ed substance, DEA implements
conclusion, the bil would require DEA to remove the
the legislative schedule change through rulemaking.
substance from the CSA schedules within 90 days.
If the Secretary determines that an FRS has a potential
for abuse that is less than the substances in Schedules I
and II and submits to DEA a scientific and medical
evaluation supporting its conclusion, the bil would
require DEA to move the substance to Schedule III
within 90 days.
The bil lists certain information the Secretary may use
in evaluating the potential for abuse of a FRS. The bil
would also authorize petitions for rescheduling of an
FRS to be considered pursuant to the foregoing
expedited procedures. It contains an exception to the
expedited descheduling or rescheduling process if a
substance is required to be control ed under the
United States’ international treaty obligations.
The bil contains a rule of construction specifying that
it does not limit DEA’s ability to deschedule or
reschedule FRS pursuant to the existing generally
applicable procedures. It also states that descheduling
pursuant to this section does not preclude DEA from
later imposing new controls.
CRS-5

Current Law/Regulation
SAFE Act (H.R. 568)
HALT Fentanyl Act (H.R. 467)
Convictions involving removed or rescheduled
Sec. 6. Past Cases Involving Removed or
No related provision.
substances.
Rescheduled Substances.
The HALT Fentanyl Act would not provide for vacatur
Multiple provisions of the CSA, including 21 U.S.C.
The SAFE Act would allow a federal court to vacate or or reduction of the sentence of a defendant convicted
§ 841(b) (discussed above), impose criminal penalties
reduce a sentence (fol owing a motion by the
of an offense involving an FRS (or any control ed
for violations of the CSA involving Schedule I
defendant, federal government, or the federal court
substance) that is removed from control or moved to
substances in general or fentanyl analogues specifically.
itself) for a defendant who has been convicted of an
a less stringent schedule.
There is currently no CSA provision that allows a
offense involving an FRS that has since been
federal court to vacate or reduce a sentence for a
descheduled or moved to any schedule other than
defendant convicted of an offense involving a FRS (or
Schedule I or II. The defendant would not be required
any control ed substance) that has since been removed to attend the hearing during which the court considers
from control or moved to a less stringent schedule.
vacating or reducing his or her sentence.
21 U.S.C. § 823 Registration requirements.
Sec. 7. Registration Requirements Related to
Sec. 3. Registration Requirements Related to
Even if a practitioner has a DEA registration for
Research.
Research.
research on Schedule II-V substances, the registrant
(a) Alternative Registration Process for
The HALT Fentanyl Act’s provisions designed to
must obtain a separate DEA registration for Schedule I Schedule I Research. The SAFE Act would create a
streamline research with Schedule I control ed
substances. 21 U.S.C. § 823(g) requires DEA registrant
simplified process for those whose research is (1)
substances, contained in subsections 3(a) through 3(g),
applications for research with Schedule I substances to
funded by HHS or the Department of Veterans Affairs, are substantively the same as subsections 7(a) through
be referred to the Department of Health and Human
or (2) done under an Investigative New Drug (IND)
7(g) of the SAFE Act.
Services (HHS; authority delegated to the Food and
exemption from FDA. Under the new process, the
Drug Administration [FDA]). FDA then determines
researcher would submit a notice to DEA containing
the qualifications and competency of each practitioner
only the fol owing information: the identity of the
requesting registration as well as the merits of the
control ed substance to be used in the research, the
research protocol. FDA, in determining the merits of
quantity of the substance to be used, demonstration
each research protocol, must consult with DEA
that one of the above criteria is met (e.g., the grant or
regarding effective procedures to adequately safeguard
project number and identification of the funding agency
against diversion of the control ed substances from
or the IND application number), and demonstration
legitimate medical or scientific use.
that the researcher is allowed to do the research
21 U.S.C. § 822 Persons required to register.
under the law of the state where the research wil be
conducted.
21 U.S.C. § 822(a) and (b) require that every individual
using a control ed substance in research must have a
Researchers currently registered to conduct research
registration to do so. 21 U.S.C. § 822(c) provides
with Schedule I or II control ed substances would be
several exceptions to the registration requirement,
permitted to begin their new research within 30 days.
such as for those who are employees of individuals
For a researcher without a current registration, DEA
who are registered.
would be directed to act within 45 days of receiving all
required information either to register the applicant or
issue an order for the applicant to show cause why
registration should not be denied.
CRS-6

Current Law/Regulation
SAFE Act (H.R. 568)
HALT Fentanyl Act (H.R. 467)
21 U.S.C. § 822(e) requires a separate registration for
(b) Separate Registrations Not Required for
each principal location where the registrant handles
Additional Researcher in Same Institutions.
control ed substances.
Registration exceptions under § 822(c) do not
Under DEA regulations, 21 C.F.R. § 1301.18, if a DEA
necessarily apply to researchers in the same institution
registrant wants to conduct research beyond the
as the Schedule I registrant (unless they are agents or
variations provided in the registrant’s approved
employees of individuals who are registered). This
protocol, the registrant must submit three copies of a
would add a subsection to § 822 which would clarify
supplemental protocol describing the new research.
that, under certain conditions, individuals in an
DEA processes supplemental protocols in the same
institution with a registered researcher may perform
manner as original research protocols.
research without being separately registered if
Under 21 U.S.C. § 822, manufacturing and research
performing research on a control ed substance in the
registrations are separate, although researchers may
same schedule. The registered researcher would be
conduct limited manufacturing as a coincident activity
required to inform DEA of the identities of all such
of their research registration without obtaining
persons conducting research without a separate
separate manufacturing registrations under certain
registration, authorize them to participate, and affirm
circumstances.
that any acts involving control ed substances by such
individuals wil be attributed to the registered
researcher.
(c) Single Registration for Related Research
Sites.
The proposal would add a subsection to § 822, which
would establish that a single registration would cover
multiple locations for the research or storage of
control ed substances so long as all the sites are under
the control of the same institution and are in the same
city or county and so long as the researcher notifies
DEA of each site before the site is used for research
or storage of the control ed substances. It would
specifically authorize DEA regulations to ensure
effective controls against diversion of substances at
these sites.
(d) New Inspection Not Required in Certain
Situations. While current law does not require a
new inspection if a registrant applies to research an
additional control ed substance under the same or a
less restrictive schedule, this new subsection would
clarify that a new inspection is not needed under this
circumstance. It would not, however, prevent DEA
CRS-7

Current Law/Regulation
SAFE Act (H.R. 568)
HALT Fentanyl Act (H.R. 467)
from conducting inspections deemed necessary to
maintain diversion control.
(e) Continuation of Research on Substances
Newly Added to Schedule I. This new subsection
under § 822 would allow researchers who have
Schedule I research registrations to continue to
conduct research with newly added Schedule I
substances on which they have been conducting
research. These researchers would have to apply
within 90 days for a registration (or a modification of
the existing registration) to work on the newly
scheduled substance, but the research could continue
uninterrupted until the application is withdrawn or
until DEA issues a show-cause order proposing to
deny the application.
(f) Treatment of Certain Manufacturing
Activities as Coincident to Research.
This new subsection under § 822 would more
generally make clear that a DEA-registered researcher
would not be required to obtain a separate
manufacturing registration if the manufactured
quantities are small and are produced for purposes of
the research and if the researcher notifies DEA of the
manufacturing activities and the quantities of the
substance in question. It would allow the creation of
different forms of the substance consistent with the
research, and it would allow dosage form development
studies performed in order to apply to FDA for an
IND exemption. It would also specify that it does not
provide authority to grow marijuana.
(g) Transparency Regarding Special
Procedures.
This new subsection under § 822 would require DEA
to make public which substances are subject to special
processes or criteria, what special processes or
criteria apply to these substances, and how those
CRS-8

Current Law/Regulation
SAFE Act (H.R. 568)
HALT Fentanyl Act (H.R. 467)
processes or criteria differ from those that apply to
other substances on the same schedule.
21 U.S.C. § 821 Rules and regulations.
Sec. 8. Rulemaking.
Sec. 4. Rulemaking.
Under 21 U.S.C. § 821, the Attorney General
This section would require DEA to issue rules
This section of the HALT Fentanyl Act is substantively
(authority delegated to DEA) is authorized to
implementing the law within one year of enactment
the same as section 8 of the SAFE Act.
promulgate rules and regulations relating to the
and authorize DEA to issue such rules as interim final
registration and control of the manufacture,
rules. An interim final rule issued by DEA under this
distribution, and dispensing of control ed substances.
subsection would become immediately effective as an
interim final rule without requiring DEA to
demonstrate good cause but would be required to
give interested persons the opportunity to comment
and to request a hearing. The bil would then require a
final rule to be issued in accordance with the
Administrative Procedure Act (5 U.S.C. § 553).
No related provision.
Sec. 9 GAO Report.
No related provision.
This section would require the Government
The HALT Fentanyl Act would not require a GAO
Accountability Office (GAO) to consult with HHS,
report.
DOJ, the Department of Homeland Security, the
Department of State, the Office of National Drug
Control Policy, the medical and scientific research
community, the law enforcement community, and the
civil rights and criminal justice reform communities
and to publish a report analyzing the implementation
and impact of permanent FRS class scheduling. GAO
would be required to analyze the impact on FRS
research, removal and rescheduling actions, the effects
on il icit FRS manufacturing and trafficking, criminal
sentences related to FRS, and the proliferation of new
control ed substance analogues.
CRS-9

link to page 15
Current Law/Regulation
SAFE Act (H.R. 568)
HALT Fentanyl Act (H.R. 467)
No related provision.
No related provision.
Sec. 6. Applicability; Other Matters.
This section would provide that the HALT Fentanyl
Act is effective upon enactment. It would further
provide that the Act may not be construed as
evidence that, with respect to conduct occurring
before the date of the enactment, an FRS is not an
analogue of fentanyl. Finally, this section would express
the sense of Congress that “[t]he Congress agrees
with the interpretation of the Control ed Substances
Act (21 U.S.C. 801 et seq.) in United States v. McCray,
346 F. Supp. 3d 363 (2018).”a
Source: Table created by CRS based on bil s introduced in the 118th Congress.
Notes: Section 1 (Short Title) of each bil was excluded because it contains only the bil title.
a. In McCray, a district court held that an “analogue of fentanyl” subject to quantity-based mandatory minimum sentences under 21 U.S.C. § 841(b) need not be a
“control ed substance analogue” as defined under 21 U.S.C. § 802(32). 346 F. Supp. 3d 363, 365 (W.D.N.Y. 2018).

CRS-10

Comparison of Proposed Legislation Concerning Fentanyl-Related Substances

Author Information

Joanna R. Lampe
Lisa N. Sacco
Legislative Attorney
Analyst in Illicit Drugs and Crime Policy

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Congressional Research Service
R47572 · VERSION 1 · NEW
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